empirical research articles on schizophrenia

• Research article
• Open access
• Published: 21 July 2017

Treatment outcomes in schizophrenia: qualitative study of the views of family carers

• Joanne Lloyd 1 ,
• Helen Lloyd 2 ,
• Ray Fitzpatrick 3 &
• Michele Peters 3  

BMC Psychiatry volume  17 , Article number:  266 ( 2017 ) Cite this article

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Schizophrenia is a complex, heterogeneous disorder, with highly variable treatment outcomes, and relatively little is known about what is important to patients. The aim of the study was to understand treatment outcomes informal carers perceive to be important to people with schizophrenia.

Qualitative interview study with 34 individuals and 8 couples who care for a person with schizophrenia/schizoaffective disorder. Interviews were transcribed verbatim and analysed by a thematic framework based approach.

Carers described well-recognised outcomes of importance, alongside more novel outcomes relating to: Safety (of the patient/others); insight (e.g. into non-reality of psychotic phenomena); respite from fear, distress or pain; socially acceptable behaviour; getting out of the house; attainment of life milestones; changes in personality and/or temperament; reduction of vulnerability to stress; and several aspects of physical health.

Conclusions

These findings have the potential to inform the development of patient- or carer- focused outcome measures that take into account the full range of domains that carers feel are important for patients.

Peer Review reports

Improving treatment outcomes and quality of life for people with long-term mental health conditions are key aims of health care policy [ 1 , 2 ]. Schizophrenia is a particularly important target, being associated with poor quality of life [ 3 ] and individual and societal impacts [ 4 , 5 , 6 ], and requiring long-term treatment [ 7 ]. Antipsychotic medications can ameliorate some symptoms and improve quality of life [ 3 , 8 , 9 ], but individual responses vary [ 10 , 11 ], and many discontinue medication due to poor efficacy or debilitating side effects [ 12 , 13 ]. Treatment outcomes are often assessed by clinician ratings, and/or symptom scales [ 14 ], but patients and carers may prioritise different outcomes to clinicians [ 15 , 16 , 17 ], and controlling symptoms is not the only outcome of importance [ 14 ]. The recovery literature draws attention to the importance of recognising a broad array of outcome domains in schizophrenia treatment, highlighting the relevance of improved social and domestic functioning, alongside subjective wellbeing, optimism and empowerment (e.g. [ 18 , 19 ]). Patients and relatives, in particular, refer to subjective wellbeing when defining ‘remission’, in contrast to traditional clinical definitions focused around reduced symptom scores [ 17 ]. People with schizophrenia value outcomes such as achieving life milestones, feeling safe, improved physical activity, employment, a positive sense of self and psychosocial outcomes [ 20 ]. Understanding the full range of treatment outcomes important to people with schizophrenia and their carers is key for ensuring that clinical practice, research and assessment are aligned with patient and carer priorities [ 4 , 21 ].

While people with schizophrenia can give valid and reliable accounts of outcomes [ 22 , 23 , 24 ], symptoms can make it difficult to participate in research [ 25 ], and carers represent a valuable additional resource [ 15 , 21 , 26 ]. Furthermore, carers have the potential to influence treatment decisions [ 26 ], and experience, indirectly, the impact of outcomes. This study sought to explore the treatment outcomes that carers feel are important for people with schizophrenia. It used a framework informed by a thematic review of the existing literature on treatment outcomes of importance to patients and carers, and a consensus conference with professionals, carers and patients, and aimed to identify whether carers report any outcome domains that have not been emphasised in the current literature.

Design of the study

A qualitative study using in-depth semi-structured interviews was conducted with self-identified ‘carers’ of a family member with a diagnosis of schizophrenia made at least 2 years previously. Ethical approval was obtained from NHS East of Scotland Research Ethics Service (EoSRES) REC 1 by proportionate review (Application Number 13/ES/0143). All participants gave written informed consent.

Participants and recruitment

A total of 34 individuals and 8 couples were interviewed (i.e. 50 people in 42 interviews). While qualitative methodology papers tend to avoid prescribing hard guidelines for sample sizes for qualitative studies, 25–30 participants have been deemed an acceptable minimum by Dworkin [ 27 ] and this number is usually sufficient for reaching data saturation. An email circulated by charity ‘Rethink Mental Illness’ was responded to by 102 people who were screened via telephone to confirm that they were the carer of someone with a ≥ 2-year diagnosis of schizophrenia or schizoaffective disorder. Within this self-selecting convenience sample, participants were then recruited purposively to generate a relatively heterogeneous final sample, consisting of 38 females and 12 males, aged from 20s–80s (48% in their 60s, 26% in their 50s, and the remainder in their 20s, 40s, 70s or 80s), and coming from urban (e.g. Greater London) and rural (e.g. Wiltshire) locations. Thirty-seven were the mother of a person with schizophrenia, 10 were the father or stepfather, one the husband, one the wife, and one the sibling. Duration of illness of the patients discussed ranged from 2 to 20+ years, with a modal duration of 11–15 years (42%). The majority ( n  = 44) cared for someone with schizophrenia, and six cared for someone with schizoaffective disorder.

Most participants chose to be interviewed at home, but approximately 20% chose to come to the University. At the beginning of the interviews, carers re-confirmed that the patient had received a formal diagnosis of schizophrenia or schizoaffective disorder from a GP or psychiatrist, at least two years prior to the interview. Carers were then asked what they felt were important outcomes of treatment for the patient who they cared for: at present; at a time when the patient was particularly ill or unwell; at a time when they were more stable; and at a time when they were doing particularly well. Prompts were designed to encourage participants to discuss both directly-experienced outcomes, and important/desired but unattained outcomes. In addition, a series of prompts relating to key outcomes were compiled based on the conceptual review of the literature and feedback from a consensus conference, but were not in fact utilised in any of the interviews, as participants spontaneously discussed a broad array of outcomes of importance in response to the preliminary, general questions. After the initial 6 interviews, when it became apparent that participants identified multiple outcomes in response to the primary questions, without need for prompts, the researchers agreed that all future interviews in the study would proceed without prompts. Carers were encouraged to expand upon ideas that they themselves raised in relation to outcomes, rather than directed towards any specific topic. It was felt that this strengthened the data, as it reduced the potential for investigator bias. The topic guide, which was reviewed for tone and content prior to use by two carers and one person with schizophrenia, can be found in online Additional file 1 . Interview duration ranged from 40 to 125 min (average, approx. 60 min).

Interviews were transcribed verbatim by a professional transcriber, and anonymised. Transcripts were analysed in NVivo 8 by JL, using a thematic, framework based approach [ 28 ]. This involved the creation of a preliminary framework based on a literature review and consensus conference. Transcripts were then analysed, with themes being coded into appropriate categories within that framework, wherever appropriate categories existed. Where themes did not fit well into an existing category, novel categories were created. Interviews were continued until no further novel categories emerged, by which point all categories had been spontaneously mentioned by several participants, and saturation was deemed to have been reached. Once all interviews had been coded, the categories were reviewed by the research team, to ensure that they were representative of all the statements coded within them. Where categories were ambiguous, e.g. contained material that could potentially be better conceptualised within different domains, or could be better represented by different titles, they were revised, and the material coded within them was re-coded in order to ensure that it was coded within the most appropriate category. A final framework that encompassed the original and the novel categories was then agreed amongst the researchers. All of the interviews were then re-coded, using the final framework. In this second iteration, the majority of the material was coded into the same categories as during the initial coding. However, this process was important to ensure that any statements that had originally been coded into categories within the preliminary framework, but in retrospect better-reflected a novel category that had been added to the final framework, were coded appropriately. RF and MP independently cross-checked the final categorisation by coding a random selection of 6 transcripts, and no disagreements emerged. Categorized data were summarized and synthesized, and the resultant categories (and associations between them) were interpreted in relation to the categories already identified within the literature and consensus conference. After the final coding, the number of interviews in which each category occurred was calculated.

Outcomes of importance in schizophrenia reported by the carers included symptom related outcomes, quality of life, functional outcomes, personal recovery, physical health and lifestyle, and satisfaction with treatment. Table 1 lists these outcomes, and their sub-categories, and the proportion of interviews in which they occurred (using the conventions: ‘few’ for 2–10% ( n  = 1–4), ‘some’ for 12–24% ( n  = 5–10), ‘many’ for 25–50% ( n  = 11–21), and ‘most’ for >50% ( n  = 22–42)). It was not necessary for a participant to overtly state that an outcome had been experienced by the person they care for, in order to code their statement as an endorsement of that domain. While ‘endorsement’ of an outcome domain did, in some cases, take this form, any statement that either explicitly or implicitly indicated that a domain was relevant or important to that carer, was also coded within that domain. For example, where a carer identified that the person they cared for experienced ongoing difficulties with engaging in physical activity, or that they wished the person they cared for could have the energy to engage in physical activity, this was interpreted as the carer indicating that being able to engage in physical activity was an important outcome, and hence it was coded within the ‘physical activity’ category.

The categories in Table 1 were first identified through a literature review and consensus conference and subsequently adapted to include the newly identified and/or expanded categories from the interview data reported here. Standard font indicates categories which were pre-identified from the literature review (and replicated in the current study), and italic font indicates novel/ modified categories which emerged from the current study (which are illustrated by quotations in Tables 3 and 4 , and discussed below). All categories in Table 1 were identified as relevant by at least some of the carers interviewed, and the majority were mentioned in >50% of the interviews.

Symptom-related outcomes (Table 2 )

Safety was mentioned in most interviews, and encompassed safety from dangerous behaviours prompted by psychosis (such as absconding/ putting oneself or others into risky situations); from health risks linked to negative symptoms (e.g. not eating, living in squalor); and from potential for deliberate self-harm related to affective symptoms.

‘It's great for it to be diagnosed, to be put on your medication and you're safe’ [C41]

The importance of reduction of, or relief from fear, distress and emotional (or even physical) pain was raised in most interviews, often closely related to positive symptoms, but at the level of their physical and emotional consequences.

‘He was absolutely intimidated by his environment… he felt frightened and threatened’ [C25]

Insight was also mentioned in most interviews, encompassing both recognition that current/prior psychotic phenomena are not real, and understanding that one has a long-term illness. It was described as a gatekeeper to many other treatment benefits, partly through its impact upon treatment adherence, and was important in helping people deal with residual psychotic phenomena.

‘He can rationalise…although he hears the voices he has a sense of reality.’ [C40]

Side-effects are not described in detail here as they are well reported within existing literature (e.g. [ 29 ]), but they were identified as important in the majority of interviews, and in addition to commonly-reported side effects (e.g. weight gain and fatigue), a few participants mentioned negative impact of medication on imagination and/or creativity, and concerns over toxicity of medication during pregnancy and breastfeeding.

Quality of life (Table 2 )

The concept of ‘social acceptability’ was raised in most interviews, i.e. behaving in a socially appropriate way and avoiding bizarre/unconventional behaviour. Many discussed the importance of treatment in helping patients avoid illegal behaviour (sometimes precipitated by symptoms).

‘[When] he's not taking his medication, he occasionally offends people in the street’ [C25]

Functional outcomes (Table 3 )

The domain of ‘life milestones’ was added to encompass many carers’ reports of the importance of reaching key life/developmental milestones, such as attaining qualifications, learning to drive, moving out of the caregiver’s home, or having a family.

‘I think he missed out all his twenties and thirties so maybe catching up in some ways.’ [C03]

Simply ‘getting out’ of the house was mentioned in most interviews, and was consequently added as a sub-category of ‘leisure pursuits’. This encompassed the importance of being well enough to leave the house, which was something many patients needed to achieve before the more ambitious step of engaging in structured leisure activities or even activities of daily living.

‘The worst time that we've had was… when he was so unwell he didn’t go out the house for a year’ [C24]

A novel sub-category of ‘pets’ was added within the ‘role functioning and productivity’ category, because the importance of being able to care for a pet was raised in some interviews.

Personal recovery (Table 3 )

The importance of ‘personality/temperament’ was raised in most interviews, and was often particularly valued by carers themselves. This encompassed emergence of aspects of the patient’s character, such as sense of humour, consideration, and thoughtfulness, and of a generally calmer temperament, more ‘like oneself’.

‘He reverted to his old self. You could reason with him, you could have a laugh with him’ [C46]

The vast majority of carers also mentioned ‘vulnerability/sensitivity’ to all kinds of stress, in most cases as a residual difficulty that treatment failed to resolve, rather than a positive, attained outcome.

‘Although he seems fairly even I don’t think it would take a huge amount to kick him over the edge.’ [C06]

Physical health and lifestyle (Table 4 )

Exercise/physical activity and diet/weight were raised by the majority of carers, who sometimes described how treatment facilitated physical activity and healthy diet (by improving symptoms that create barriers), but also described how side-effects (such as alteration in appetite/metabolism, and fatigue) could act as barriers.

‘On such a high dose… of a sedating medication. Motivation is just not there’. [C46]

Many described the importance of outcomes related to drugs/alcohol/smoking, such as decreased reliance upon substances previously used to self-medicate positive or affective symptoms, or compensate for lack of social/functional activities.

‘She was drinking herself to sleep, I think, mostly because she had recurrent nightmares, and day time nightmares’ [C50]

Daily routine was mentioned in many interviews, in relation to sleep and waking, eating and self-care, and was described both as a factor that contributed to improving other outcomes, and as an outcome in itself.

Principle findings

All the schizophrenia treatment outcomes identified in the literature review and consensus conference preceding the study (i.e. symptom-related outcomes; functional outcomes; personal recovery; quality of life; and satisfaction with treatment) were confirmed in these qualitative interviews, along with several novel sub-categories within existing domains and a novel category of physical health and lifestyle, thus giving a deeper understanding of outcomes in this condition. While a large proportion of the sample endorsed most of the themes, it should be noted that frequency information are indicative of the frequency of these domains within our sample, and cannot be extrapolated from to estimate the prevalence of these concerns in carers of persons with schizophrenia.

While the importance of physical activity for persons with schizophrenia is recognised within the literature [ 30 ], and low levels of physical activity have been demonstrated empirically to be associated with poorer outcomes in schizophrenia [ 31 ], its importance as a treatment outcome is not expressed in existing outcome measures. This highlights the need to consider physical activity as a potentially relevant outcome domain in its own right. Designing interventions for schizophrenia that include attention to physical health and lifestyle, could help improve outcomes for many patients.

Safety of the patient (and those around them), and reduction of their fear, distress or pain, were considered important by most carers, and it is easy to see why they would value these outcomes, relating to resolution of negative practical and emotional consequences of symptoms. While the importance of these outcomes may be intuitive, they are not explicitly represented in current outcome measures, and this study is novel in highlighting their particular salience. These outcomes could be described as ‘secondary’, in the sense that they could be logically expected to follow on from the more ‘primary’ outcome of amelioration of (particularly, positive) symptoms. However, it could also be argued that there are other means of reducing patients’ fear, distress, or pain, aside from by symptom resolution, and thus outcome measures could benefit from assessing the extent to which treatments help to reduce a patient’s experience of these negative states. This could help professionals to gain a fuller understanding of how a given treatment programme is impacting on the individual’s level of fear and distress.

Most carers also valued insight which they often reported to be associated with improved communication with the person with schizophrenia, and a return of their personality and/or of a more favourable, ‘normal’ temperament. This is consistent with findings that insight in schizophrenia is associated with social cognition [ 32 ], and lower scores on an aggression scale [ 33 ]. Carers also described insight’s importance for enabling patients to apply cognitive strategies to counter paranoid thoughts, delusions or hallucinations, consistent with the finding that insight can be predictive of prognosis [ 34 ]. Monitoring level of insight may be beneficial in order to inform decisions about when cognitive interventions may be more effective. Exploring the value of educating carers in ways to cope with poor insight in the person for whom they care, could be another important target for future work.

Within functional outcomes, many carers talked of ‘getting out’ (i.e. leaving the house), similar to the existing domain of engaging in leisure pursuits, but at a more preliminary level. Caring for pets, similarly, could be conceptualised as a specific form of role functioning/productivity. Where residual difficulties are considerable and/or recovery is particularly limited, less ‘ambitious’ functional outcomes such as these may be particularly relevant. This is consistent with the observation that traditional social functioning measures may not be relevant to people with severe disabilities related to schizophrenia [ 35 ], and with carers’ comments about reduced potential and lowering of expectations. From carers’ references to a range of key developmental/life events such as moving out of the family home, getting a job, learning to drive, and having a romantic relationship, we identified ‘reaching life milestones’ as an important and novel outcome. Because schizophrenia onset is typically during adolescence or early adulthood [ 36 ], before traditional milestones have been reached, it is logical that the reaching of milestones would for many be the goal, rather than the resumption of familial, domestic, occupational or educational roles and responsibilities. This highlights the fact that functional outcome measures in schizophrenia may need to take subtle levels of attainment into account, in order to accurately capture small gains.

Within the realm of ‘personal recovery’ many carers highlighted the importance of changes in personality and temperament, and several described the return of the person they used to know as the most important outcome; understandably so, considering that these are good outward indicators of wellness and ‘personal recovery’ and directly impact upon the patient-carer relationship. Indeed, temperament has been linked with functional outcomes and psychological health [ 37 ]. Also relating to personal recovery, many carers discussed patients’ vulnerability (to stress, and in general) and sensitivity, consistent with empirical findings of increased biological reactivity to stress in schizophrenia [ 38 ]. These were typically described as residual unresolved difficulties, and several carers reported that they limited patients’ attainment of functional outcomes and acted as precipitants of relapse, requiring careful monitoring. This could indicate a potential benefit to be found in involving carers, where appropriate, in helping patients to monitor level of stress, and react quickly to try and reduce its impact.

In the sub-category of ‘leading a normal life’, a number of carers spoke of the importance of treatment for helping patients to avoid socially unacceptable/antisocial/illegal behaviours, (often precipitated by positive symptoms), in order to reduce risk of arrest or sectioning, facilitate social interactions and minimise stigma – consistent with findings that socially unacceptable behaviour is strongly associated with stigma in schizophrenia [ 39 ].

Consistent with other studies, many carers expressed desire for greater monitoring of physical health [ 40 ]. Exercise/physical activity, diet, and weight were all salient concerns; again consistent with findings of elevated obesity [ 41 ] and low activity [ 42 ] in schizophrenia/severe mental illness. A wide range of contributing factors were cited by the carers, including medication side effects, positive, negative and affective symptoms, and eating replacing less attainable leisure pursuits. Several also described patients who used alcohol or drugs to self-medicate and/or compensate for a lack of alternative leisure outlets; consistent with reported motivations for substance use in schizophrenia [ 43 ]. Some carers did describe physical health benefits of treatment, e.g. where it reduced use of drugs or alcohol for self-medication, or reduced symptoms enough to allow patients to exercise or shop for healthy food. In relation to lifestyle more generally, several carers emphasised the importance of routine, as a desirable outcome and useful intervention for facilitating the attainment of other outcomes (consistent with a study where people with schizophrenia rated organization of time as a useful coping strategy [ 44 ]). The discovery that physical health is an important concern in schizophrenia is not novel, but this study does support the growing body of work emphasising the importance of incorporating physical health interventions into schizophrenia treatment programmes (e.g. [ 45 ]).

Strengths and limitations

This study confirms the key treatment outcome categories found in the current literature, and contributes evidence of additional outcomes that carers feel are important for patients but are not apparently captured in current thinking about, and measurement of, schizophrenia outcomes. However, there are some possible biases in the sample. The majority of carers interviewed were parents of a person with schizophrenia, with a gender bias in the sample, such that around three quarters of participants were female. However, this is in line with the gender balance found in other convenience samples of carers of persons with schizophrenia [ 46 ], and reflects the fact that mothers are most frequently the primary carer in schizophrenia [ 47 ]. It is possible that spouses, siblings, or children (or those of a younger age in general) may have different perceptions of what the important outcomes are. Most participants were recruited via Rethink Mental Illness, which may have meant they were particularly well-informed about features of schizophrenia and issues around treatment. Finally, the patients discussed were typically quite advanced in chronicity (in most cases >10 years post-diagnosis). While carers were asked to discuss outcomes that they felt were important at different phases of illness, it is nevertheless possible that carers of patients more immediately post-diagnosis would report different outcomes. Future studies could benefit from exploring outcomes with younger carers with different relationships to the patient, from a range of backgrounds, and those caring for people more early post-diagnosis.

The outcomes carers identified as being important for patients may not be identical to the outcomes that patients themselves would identify. However, there is generally good agreement between the two [ 21 ], and as agents who potentially influence patients’ treatment decisions [ 16 ], and experience the consequences of the illness [ 48 ], carers’ views are important in their own right. Furthermore, we were able to gain insight into outcomes that might not otherwise have been represented, as most of the carers interviewed reported that the patients they were speaking about would have been unwilling/unable to participate (e.g. ‘he hates talking about it when he was really ill… he said, “It makes me feel so ill again” [C41]).

The findings from this study contribute to our understanding of the full range of treatment outcomes that carers feel are important to people with schizophrenia, and could contribute to ensuring research, treatment planning and assessment are aligned with the needs and priorities of patients [ 4 ]. The breadth of information gleaned from these interviews with family carers indicates what an important resource this population represents. Furthermore, it is clear that informal carers typically bear a high burden of care in schizophrenia [ 49 ]. Working with carers to gain insights and coordinate interventions, where appropriate, could be a valuable way for professionals to develop person-centred approaches in schizophrenia. Outcomes of treatment should ideally be assessed with measures that both complement existing clinical scales and incorporate patient and carer priorities. The domains and more specific experience emphasised here should inform the further development of such patient- or carer- focused outcome measures in order to ensure more appropriate and complete evaluation of interventions.

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Acknowledgments

The authors would like to acknowledge the support of Rethink Mental Illness in advertising the study, and the input of all the carers who took part.

This work was supported by EUFAMI, the European Federation of Associations of Families with Mental Illness.

Dr. Joanne Lloyd was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford whilst working on drafts of this article. Dr. Helen Lloyd was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula whilst commenting on drafts of this paper. Throughout this project, Prof Ray Fitzpatrick and Dr. Michele Peters were supported by the Department of Health funded Policy Research Unit on Quality and Outcomes of Person Centred Care (QORU), a collaboration between the London School of Economics and Political Science (LSE) and the Universities of Kent and Oxford. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

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Lloyd, J., Lloyd, H., Fitzpatrick, R. et al. Treatment outcomes in schizophrenia: qualitative study of the views of family carers. BMC Psychiatry 17 , 266 (2017). https://doi.org/10.1186/s12888-017-1418-8

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Functioning in schizophrenia from the perspective of psychologists: A worldwide study

Roles Conceptualization, Data curation, Formal analysis, Methodology, Software, Visualization, Writing – original draft

* E-mail: [email protected]

Affiliations Clinical Institute of Neurosciences (ICN), Hospital Clinic, Barcelona, Spain, Department of Social Psychology and Quantitative Psychology, University of Barcelona, Barcelona, Spain

Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Software, Supervision, Validation, Writing – review & editing

Affiliations Department of Social Psychology and Quantitative Psychology, University of Barcelona, Barcelona, Spain, Group on Measurement Invariance and Analysis of Change (GEIMAC), Institute of Neurosciences, University of Barcelona, Barcelona, Spain

Roles Conceptualization, Investigation, Methodology, Writing – review & editing

Affiliations Institute for Medical Information Processing, Biometry and Epidemiology–IBE, Research Unit for Biopsychosocial Health, Ludwig-Maximilians-Universität (LMU), Munich, Germany, Pettenkofer School of Public Health, Munich, Germany, ICF Research Branch, a cooperation partner within the WHO Collaborating Centre for the Family of International Classifications in Germany (at DIMDI), Munich, Germany

Affiliations Hospital Benito Menni CASM, Sisters Hospitallers, Sant Boi de Llobregat, Spain, Department of Psychiatry, International University of Catalonia, Barcelona, Spain

Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing

Roles Conceptualization, Data curation, Formal analysis, Resources, Software, Supervision, Writing – review & editing

• Laura Nuño, 
• Georgina Guilera, 
• Michaela Coenen, 
• Emilio Rojo, 
• Juana Gómez-Benito, 
• Maite Barrios

• Published: June 6, 2019
• https://doi.org/10.1371/journal.pone.0217936
• Reader Comments

Schizophrenia is a severe mental disorder associated with impairment in functioning. A multidisciplinary approach is essential to help individuals with this health condition, and psychological interventions are considered a priority. The International Classification of Functioning, Disability and Health (ICF) offers a theoretical framework for assessing functioning and disability. The ICF Core Sets for schizophrenia are a list of ICF categories describing the most common problems in functioning of persons affected by this health condition. This study aimed to explore the content validity of these ICF Core Sets and to identify the most common problems in people with schizophrenia from the perspective of psychologists. Psychologists with experience of schizophrenia treatment were recruited for a three-round Delphi study in order to gather their views regarding the problems commonly presented by these patients. A total of 175 psychologists from 46 countries covering the six WHO regions answered the first-round questionnaire, and 137 completed all three rounds. The 7,526 concepts extracted from first-round responses were linked to 412 ICF categories and 53 personal factors. Consensus (≥75% agreement) was reached for 76 ICF categories and 28 personal factors. Seventy-three of the 97 ICF categories that form the Comprehensive ICF Core Set for schizophrenia achieved consensus, and only three categories that yielded consensus do not feature in this Core Set. These results support the content validity of these ICF Core Sets from the perspective of psychologists. This provides further evidence of the suitability of the ICF framework for describing functioning and disability in persons with schizophrenia.

Citation: Nuño L, Guilera G, Coenen M, Rojo E, Gómez-Benito J, Barrios M (2019) Functioning in schizophrenia from the perspective of psychologists: A worldwide study. PLoS ONE 14(6): e0217936. https://doi.org/10.1371/journal.pone.0217936

Editor: Eduardo Fonseca-Pedrero, University of La Rioja, SPAIN

Received: January 26, 2019; Accepted: May 21, 2019; Published: June 6, 2019

Copyright: © 2019 Nuño et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: The data will be held in the University of Barcelona's repository by clicking this link: http://hdl.handle.net/2445/127181 .

Funding: This work was supported by Spain’s Ministry of Economy and Competitiveness [grant PSI2015–67984-R], and by the Agency for the Management of University and Research Grants of the Government of Catalonia [grant 2017SGR1681]. J. Gómez-Benito was the author who received the funding. The grants financed the preparation of the materials in the five languages in which it was applied, the Qualtrics platform through which the data were collected, and the linguistic revision of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Schizophrenia is a severe mental disorder that afflicts more than 21 million people worldwide [ 1 ]. It has a multifactorial etiology, with numerous individual variables interacting with several environmental factors [ 2 ]. Its lifetime prevalence is estimated at between 0.3% and 0.7%. The disorder is characterized by the presence of delusions, hallucinations, disorganized thinking, abnormal motor behavior (including catatonia), and negative symptoms[ 3 ]. Although this wide range of symptoms can be present in different combinations[ 4 ], patients across the schizophrenia spectrum commonly experience impairments, limitations, and restrictions in major areas of functioning (such as education, work, interpersonal relations, or self-care). Better and more targeted treatment of these areas would help to decrease the stigma that surrounds this illness and empower patients to improve their quality of life [ 5 ].

A multidisciplinary approach to both assessment and clinical intervention is essential to support individuals with this health condition. Worldwide clinical guidelines consider psychological interventions to be one of the mainstays of treatment and emphasize the importance of cognitive-behavioral therapy, cognitive remediation, and family intervention [ 6 – 8 ]. The goals of these interventions are manifold, with key targets being to improve psychological wellbeing and quality of life, neurocognition, and family communication. Other main objectives include training in social skills and problem solving, reducing positive and negative symptoms, and modifying contextual factors to facilitate recovery [ 9 ]. Psychological assessment focuses on the same areas and encompasses both neuropsychological testing and the evaluation of psychosocial functioning [ 10 ].

Achieving these therapeutic goals requires a proper understanding of each patient’s functioning and health status. At the 54th World Health Assembly on 22 May 2001 the International Classification of Functioning, Disability and Health (ICF) was officially endorsed (resolution WHA 54.21 ) by all 191 member states of the World Health Organization (WHO) as the international standard to describe and measure health and disability [ 11 ]. The ICF is based on a multidimensional, biopsychosocial approach (see Fig 1 ) and considers a patient’s functioning as a dynamic interaction between the underlying health condition and specific personal and environmental contextual factors. Its worldwide acceptance and applicability to all health conditions is one of its main contributions in comparison with other evaluation systems. Another key strength is its multidisciplinary approach, insofar as it provides a common language that can be used by all the professionals and healthcare disciplines involved in a person’s care. A comprehensive framework employing a universal language that is understood by all actors could improve the implementation of care plans, leading to a common understanding and shared goals between all health professionals. The ICF provides just such a framework.

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The ICF as a whole includes more than 1400 categories and hence is not suited to application in everyday clinical practice. Consequently, the WHO has established a protocol to develop ICF Core Sets (ICF-CSs) for specific health conditions. Each ICF-CS comprises a selection of ICF categories that are considered essential for describing the functioning of a person living with the corresponding health condition. Following the methodology endorsed by the WHO [ 12 ], the ICF-CSs for schizophrenia have already been developed through a formal decision-making consensus process, integrating evidence from four preparatory studies and expert opinion [ 13 ]. The Comprehensive ICF-CS for schizophrenia consists of 97 categories covering the characteristic spectrum of problems in functioning and health that are experienced by individuals with this disorder; it also includes environmental factors. The Brief ICF-CS for schizophrenia includes just 25 of these categories, the ones considered most important for the purposes of assessment and treatment. The two ICF-CSs for schizophrenia are available for free download at: https://www.icf-research-branch.org/icf-core-sets-projects2/mental-health/icf-core-set-for-schizophrenia .

A basic requirement for the implementation of these ICF-CSs in clinical practice is their validation from different perspectives. The content validity of the ICF-CSs for schizophrenia has already been examined and supported from the perspective of psychiatrists [ 14 ]. The goal of the present study was to build on this by exploring content validity from the perspective of psychologists, another group of health professionals closely involved in the care of individuals with schizophrenia. Specifically, our two objectives were: 1) to identify the problems, personal characteristics/resources, and aspects of the environment that psychologists regard as most important for understanding functioning in people with schizophrenia; and 2) to analyze the extent to which the problems and aspects identified are represented in the ICF-CSs for schizophrenia.

We conducted a three-round worldwide Delphi study by means of an e-mail survey. This is a multistage process in which each stage or round builds on the results of the previous one in order to gather and provide information about a particular subject [ 15 ]. The purpose is to achieve consensus from a panel of individuals with knowledge of the topic of interest (hereinafter, experts). The Institutional Review Board Committee of University of Barcelona approved the Study IBR00003099. Participants were provide with a written consent form. The study procedure was the same as that used in the validation study of the ICF-CS for schizophrenia from the perspective of psychiatrists, and hence further details can be consulted in Nuño et al. (2018) [ 14 ].

Recruitment of participants

Expert psychologists from around the world were recruited by contacting international associations of psychologists, universities with health professional training programs, and hospitals. We also made use of literature searches, LinkedIn contacts, and personal recommendations. To ensure that study participants were all “informed individuals” with regard to the treatment of individuals with schizophrenia, the initial invitation letter specified that they should be “psychologists experienced in the treatment of schizophrenia”. In addition, it was made clear that they should have at least one year experience of treating adults with schizophrenia.

Our aim was to recruit a panel of experts as broad and heterogeneous as possible and to achieve consensus and common opinion despite and across this variability. Indeed, we sought to obtain a sample of experts that, as far as possible, reflected worldwide variety in all the variables considered (e.g., gender, age, years of experience, and region). Furthermore, experts did not need to have specific knowledge about the ICF, and they were selected without taking into account their therapeutic orientation or training background. It was made clear that they should base their answers on their clinical experience. Those psychologists who had participated in any earlier stage of developing the ICF-CS for schizophrenia were not eligible for the present study.

All potential participants received an invitation with basic information about the study and what would be required of them. They were also asked to provide demographic and professional data. Of the 1,555 health professionals who agreed to take part and who provided demographic and professional data, 223 were psychologists who met the eligibility criteria and who were therefore invited to begin round one of this study.

A total of 175 psychologists from 46 countries covering the six WHO regions answered the first-round survey (78.5% of the 223 who were sent the survey material). They primarily worked in clinical practice (mean 46.3% of their time), followed by research (28.1%), teaching and training (16.9%), management (7.8%), and other tasks (0.9%). Table 1 shows participants’ demographic and professional characteristics. The second-round survey was answered by 151 psychologists, and 137 completed the third round, with a response rate across rounds one to three of 78.3%.

https://doi.org/10.1371/journal.pone.0217936.t001

There were no statistically significant differences in age, gender, or population treated (urban, rural, acute, and chronic) between psychologists who responded in the first round and those were invited to take part but did not do so. However, there was a significant difference between these two groups in years of experience (p < .01), since the invited experts who did not respond were less experienced than those who did take part. Specifically, 52% of invited experts who did not respond had less than five years’ experience in the treatment of individuals with schizophrenia, while this was the case for only 20% of the experts who did take part in the first round.

There were no significant differences in age, gender, or years of experience in treating individuals with schizophrenia between the groups that responded across rounds 1 to 3.

Material and data collection

With the aim of avoiding language barriers and encouraging participation by experts from different world regions, the study was conducted in five languages (Chinese, English, French, Russian, and Spanish). The survey materials were independently translated and supervised by at least two native speakers. The Delphi process is shown in Fig 2 . Data were collected between March and June 2017, with participants being allowed two weeks to respond in each round.

https://doi.org/10.1371/journal.pone.0217936.g002

Responses in the first Delphi round were logged using an online survey system ( www.qualtrics.com ). Participants were sent an e-mail with a link to the survey homepage and instructions (i.e., to list all the aspects they considered to be relevant when assessing and/or treating individuals with schizophrenia). To help them with this survey they were asked to consider six open-ended questions that covered all four components of the ICF-CS; the Environmental factors component was divided into supportive and hindering factors (survey questions can be consulted in S1 Text ). The expected completion time for each survey round was about 15 minutes.

The responses gathered in the first round were then linked to ICF categories using established ICF linking rules [ 16 , 17 ]. All categories reported by at least 5% of the experts were listed and presented to the panel in the second Delphi round. Specifically, all the panelists who had responded in the first round were sent a list of the selected ICF categories linked to the responses of all participants, as well as a list of the categories proposed for Personal factors , along with their respective definitions. The categories included in the ICF-CSs for schizophrenia were also listed. For each category, they were asked to indicate whether it was relevant from their perspective as a psychologist to the assessment and/or treatment of individuals with schizophrenia. They were reminded that the aim was to obtain a final list that was both short enough to be applicable in clinical practice and sufficiently comprehensive to cover the most important needs of people with schizophrenia. Participants in the third round were asked to evaluate the same list of categories again, this time taking into account the feedback they were sent concerning the responses of the panel and their own previous responses.

All components of the ICF, except Personal factors , are organized hierarchically in an exhaustive list of categories (see Fig 3 ). Third- and fourth-level categories are more specific than second-level categories, and they share the attributes of the second-level category with which they are associated. Therefore, their use implies that the corresponding second-level category is applicable.

https://doi.org/10.1371/journal.pone.0217936.g003

Two health professionals with experience of treating persons with schizophrenia and trained in the use of the ICF independently linked all responses from the first Delphi round to the corresponding ICF categories. For instance, if the reported problem was ‘executive dysfunction’, the concept ‘executive function’ was extracted and assigned to the ICF category b164 Higher-level cognitive functions . Any disagreements between the two independent coders were reviewed and discussed by two other health professionals with the aim of achieving consensus.

Personal factors were defined as the particular background of an individual’s life and living situation (e.g., age) [ 18 ]. Personal traits that constitute a premorbid predisposition of individuals and which affect how they cope with their illness were considered as Personal factors , whereas personality traits that are altered due to the illness were coded under category b126 of Body functions . As Personal factors are not currently categorized in the ICF, they do not feature in the ICF-CS for schizophrenia. However, as they are relevant to assessment and intervention planning, concepts related to Personal factors were summarized and considered in rounds two and three of the Delphi study. The proposed categorization of Personal factors was developed by consensus among three psychologists (L.N., M.B., G.G.) based on previously proposed categorizations of personal factors [ 14 , 18 , 19 ] and on the experts’ responses to the question about personal factors.

Data analysis

We calculated descriptive statistics for the sociodemographic characteristics of participants and the frequencies of ICF categories. In order to be able to compare our findings with the ICF-CSs for schizophrenia, which comprise solely second-level categories, all third- and fourth-level categories identified in the Delphi process were aggregated to their corresponding second-level category.

Based on previous studies [ 14 , 20 ], consensus was defined as agreement among at least 75% of participants. Inter-coder reliability was assessed by calculating the delta statistic and 95% confidence intervals (95% CI) [ 21 ]. In order to facilitate comparison with previous studies that use the kappa index, we also calculated this statistic and its 95% CI [ 22 ].

The categories for which there was agreement in the third round were compared with the categories included in both the Brief and Comprehensive ICF-CSs.

Linking process

From the experts’ answers in round one, a total of 7,526 concepts were extracted and linked to 412 ICF categories (219 second-level, 189 third-level, and 4 fourth-level). Fifty-three categories were proposed for the Personal factors identified. Aggregation of third- and fourth-level categories to their corresponding second-level category yielded a list of 223 second-level ICF categories. Those ICF categories and Personal factors that were reported by less than 5% of the experts (98 ICF categories and 20 personal factors) were excluded from the second round; ICF categories coded as ‘other specified’ or ‘unspecified’ at the second-level ( n = 11 ICF categories) were also excluded. This meant that in round two, the panel had to consider a list of 114 second-level ICF categories and 33 Personal factors . In the third round, consensus (i.e., agreement of at least 75%) was reached for 76 ICF categories and 28 Personal factors . Data regarding the categories presented to experts in rounds two and three and the degree of consensus reached are shown in the first two rows of Table 2 . Applying the delta statistic method, a general index of .90 [95% CI: .89 - .91] was obtained, indicating that 90% of agreements were not due to chance. The kappa coefficient for the linking process was .90 [95% CI: .88 - .92].

https://doi.org/10.1371/journal.pone.0217936.t002

Correspondence between panel responses and the ICF core sets for schizophrenia

Agreement of 75% or higher was reached for 75.3% of the categories included in the Comprehensive ICF-CS for schizophrenia and for all the categories in the Brief version. Therefore, the following analysis refers solely to the Comprehensive ICF-CS. A summary of the results is shown in the third and fourth row of Table 2 . More detail regarding the categories listed by the experts and the corresponding percentage analyses is provided in S1 – S5 Tables. Table 3 lists the categories that did not match in the two sets of data (the set of categories included in the ICF-CS for schizophrenia and the set of categories that reached consensus).

https://doi.org/10.1371/journal.pone.0217936.t003

With respect to the Body functions component, an agreement of 75% or higher was achieved for 14 categories. Of these, only one ( b126 Temperament and personality functions ) does not feature in the ICF-CS for schizophrenia. Four of the 17 categories that are included in the ICF-CS for schizophrenia ( b330 Fluency and rhythm of speech functions , b530 Weight maintenance functions , b640 Sexual functions , and b765 Involuntary movement functions ) did not achieve consensus in the Delphi study (see S1 Table for more details).

Regarding the Body structures component, the ICF-CS for schizophrenia does not contain any category from this component. However, one of its categories ( s110 Structure of brain ) reached an agreement of 90% in the Delphi study (for more details, see S2 Table ). With respect to the Activities and Participation component, all the categories that reached consensus ( n = 32) form part of the ICF-CS for schizophrenia. Sixteen categories from this component that are included in the ICF-CS for schizophrenia did not yield consensus (see S3 Table for more information).

Twenty-nine categories from the Environmental factors component yielded agreement of at least 75%, and only one of them ( e135 Products and technology for employment ) is not included in the ICF-CS for schizophrenia. Four categories from this component that do feature in the ICF-CS for schizophrenia did not reach consensus in the Delphi study (see S4 Table ).

In summary, only three of the 76 categories that yielded an agreement of at least 75% do not feature in the Comprehensive ICF-CS for schizophrenia. Twenty-four categories that form part of the ICF-CS did not achieve consensus among the experts. Regarding Personal factors , which are not classified in the ICF, 33 concepts were presented to the experts, and 28 of these yielded consensus (see S5 Table ).

This validation study highlights the functioning-related issues that psychologists encounter in their work with individuals with schizophrenia and considers the extent to which these aspects are covered by the ICF Core Sets for schizophrenia. All categories included in the Brief ICF-CS for schizophrenia were selected by 75% or more of participating experts, thus supporting the relevance of the categories that form this ICF-CS. We will therefore focus on comparing our results with the categories featured in the Comprehensive ICF-CS for schizophrenia. As many of the categories listed in that Core Set were considered important by more than half the experts but did not reach the threshold for consensus (75% agreement), the results are discussed by considering categories that were clearly excluded (50% or less of agreement), those whose relevance appears to be ambiguous (between 50% and 75% of agreement), and those for which there was consensus (75% or more agreement).

Concerning the Body functions component, all the categories that yielded consensus belong to chapter b1 Mental functions . Some of the categories that achieved higher consensus refer to cognitive functions, such as b164 Higher-level cognitive functions . This area is one of the main targets of psychological interventions such as cognitive remediation therapy (CRT), which aims to improve neurocognition and other functional outcomes in individuals with schizophrenia [ 23 ]. Psychological interventions also address other categories that were associated with high agreement, namely psychosocial functions ( b122 Global psychosocial functions [ 24 ]), functions affected by negative symptoms (e.g., b130 Energy and drive functions and b152 Emotional functions [ 25 , 26 ]), and classical symptoms in schizophrenia such as delusions and hallucinations (e.g. b156 Perceptual functions [ 27 ]). These results differ slightly from those obtained from the perspective of psychiatrists [ 14 ]. Although psychiatrists highlighted the importance of many categories from chapter b1 Mental functions , they also emphasized other categories from the Body functions component, such as b530 Weight maintenance functions or b765 Involuntary movement functions . This is consistent with the more biomedical perspective of psychiatrists.

Only one of the categories from the Body functions component ( b126 Temperament and personality functions ) that reached an agreement of at least 75% is not included in the ICF-CS for schizophrenia. As this category also reached consensus in the validation study from the perspective of psychiatrists it clearly reflects a problem area for these patients [ 28 , 29 ], and therefore its exclusion from the ICF-CS for schizophrenia should be reconsidered. Four categories from the Body functions component of the ICF-CS (i.e., b330 Fluency and rhythm of speech functions , b530 Weight maintenance functions , b640 Sexual functions , and b765 Involuntary movement functions ) did not achieve consensus in the Delphi study but were considered important by more than half the experts. This suggests that these categories are relevant to the assessment of and intervention with persons with schizophrenia, but that they may not be the most common target of psychologists’ interventions, which focus primarily on mental rather than other body functions [ 23 ]. In fact, these functions are mainly assessed by other professionals, such as endocrinologists (weight maintenance) or physiotherapists (movement abnormalities).

Although no category from the Body structures component is currently included in the ICF-CS for schizophrenia, 90% of the psychologists agreed that brain structure ( s110 Structure of brain ) is an essential aspect to consider when treating individuals with schizophrenia. The relevance of this category was likewise noted in the Delphi study from the perspective of psychiatrists [ 14 ], where agreement was even higher (97%). The literature also supports the idea that the brain is the main altered structure in this illness and it is considered to be the basis of other dysfunctions such as neuropsychological impairment [ 30 ]. There is also evidence that psychological interventions produce changes in brain structure and its functioning [ 31 ], with this being the goal of interventions such as cognitive remediation. Thus, from the perspective of psychologists, inclusion of this category in the ICF-CS for schizophrenia should be considered.

The component with the largest number of categories achieving consensus was Activities and Participation . These categories covered all its chapters and focused especially on learning and applying knowledge (e.g., d160 Focusing attention ), interpersonal interactions (e.g., d720 Complex interpersonal interactions ), and major life areas such as education (e.g., d830 Higher education ) and employment (e.g., d845 Acquiring , keeping and terminating a job ). Once again, these results are consistent with those obtained in the validation of the ICF-CS for schizophrenia from the perspective of psychiatrists. All categories of the Activities and Participation component for which consensus was reached are listed in the ICF-CS for schizophrenia. This reflects the fact that schizophrenia has a major impact on everyday functioning in all these areas, and illustrates why the main long-term therapeutic goals in the psychological treatment of these individuals are not limited to specific symptoms, but rather focus on improving patients’ psychosocial functioning [ 32 , 33 ]. Sixteen categories that are included in the Activities and Participation component of the Comprehensive ICF-CS for schizophrenia were initially referred to by many of our experts but did not reach the threshold for consensus. Of these, the ambiguous categories (i.e., those selected by more than 50% but less than 75% of the expert panel) mainly belong to chapter d6 Domestic life (e.g., d640 Doing housework ) or are related to employment (e.g., d855 Non-remunerative employment ). It is worth noting that these categories did yield agreement of 75% or higher in the Delphi study from the perspective of psychiatrists, thus highlighting how different professional views may complement one another. The Comprehensive ICF-CS categories that were selected by fewer than 50% of psychologists mainly referred to simple activities such as d210 Undertaking a single task and d330 Speaking , whereas consensus was achieved for the equivalent more complex categories (e.g., d220 Undertaking multiple tasks ). These results offer a more positive view of the abilities of people with schizophrenia, since it suggests that their difficulties mainly depend on the complexity of the task.

As in the previous study from the perspective of psychiatrists, the component with the second highest number of categories showing agreement of at least 75% was Environmental factors . The agreed-upon categories especially concerned support and relationships (e.g., e320 Friends ), attitudes ( e410 Individual attitudes of immediate family members ), and the accessibility of health services ( e580 Health services , systems , and policies ). These results suggest that psychologists ascribe considerable importance to the impact of environmental factors on the functioning of a person with schizophrenia, a point already made by other authors [ 34 , 35 ]. Of the 29 categories from this component that yielded consensus in the Delphi study, only one (i.e., e135 Products and technology for employment ) is not included in the ICF-CS for schizophrenia. This category belongs to chapter e1 Products and Technology , and it should be noted that the ICF-CS for schizophrenia already contains four categories from the same chapter (i.e., e110 Products or substances for personal consumption , e125 Products and technology for communication , e130 Products and technology for education and e165 Assets ). Given that an ICF-CS needs to be as short as possible, this domain may already be sufficiently covered by these four categories. Four categories from the Environmental factors component of the ICF-CS for schizophrenia did not achieve consensus but were selected by more than 50% of the experts surveyed. This suggests that these categories (e.g., e555 Associations and organizational services , systems , and policies ) may be relevant to the assessment and treatment of individuals with schizophrenia, but that they are not primary targets of psychological intervention. Once again, these categories did yield agreement of at least 75% in the Delphi study from the perspective of psychiatrists, underlining the importance of analyzing functionality from a multidisciplinary point of view.

Concerning the Personal factors component, we drew up a proposed list of 33 personal factors, 28 of which achieved consensus in the third Delphi round. This level of agreement supports the relevance of personal factors to the assessment and treatment of individuals with schizophrenia. Personal factors, such as resilience [ 36 , 37 ], premorbid cognitive skills [ 38 ], premorbid social skills [ 39 ], personal history and biography [ 40 ], premorbid drug use and lifestyle [ 41 ], and premorbid personality [ 42 ] have been considered to influence how people with schizophrenia cope with their illness. Most of the categories that psychologists regarded as important coincide with those identified in the validation study from the perspective of psychiatrists [ 14 ], suggesting that the proposed list of Personal factors captures the aspects that merit particular consideration in this population. In light of these results, it would be useful if the ICF included comprehensive specifications of ‘Personal factors’, or at least a list of such factors, so as to enable more systematic reporting of the personal factors that influence functioning and health and to further stimulate research in this important area [ 43 ].

Twenty-four categories that feature in the ICF-CS for schizophrenia did not achieve agreement of 75% in the present Delphi study. This is likely due to the multidisciplinary approach that was used to develop this ICF-CS, which aims to cover the main intervention targets not merely of a specific professional group (in this case, psychologists) but of all health professionals involved in the treatment of individuals with schizophrenia [ 11 ].

A particular strength of the present study is that the panel of experts comprised 175 psychologists from 46 countries covering all six WHO regions. Such a large sample is not common in this kind of study [ 44 , 45 ]. Furthermore, all the experts surveyed had considerable experience (54.7% with 10 or more years) in the treatment of patients with schizophrenia, both acute and chronic and from both rural and urban settings. Another strength of the study is that participation was possible in any of five languages, and this is likely to have been a key factor in achieving such a multicultural and multinational representation. It should also be noted that the response rate across rounds one to three was 78%, considerably higher than the mean across rounds of 50% that is reported in the literature [ 46 ]. The primary limitation of the study concerns the representativeness of the panel of experts. Although psychologists from all over the world took part, the Eastern Mediterranean, Western Pacific, and African WHO regions were under-represented, and this may limit the external validity of our results. Possible reasons for this under-representation include limited internet access and lower numbers of psychologists in these regions.

To conclude, the results of this study provide strong support for the content validity of the Comprehensive ICF-CSs for schizophrenia as they were obtained by surveying psychologists from all six WHO regions. Of the ICF categories that were selected by at least 75% of experts in the Delphi study, 96% feature in the Comprehensive ICF-CS for schizophrenia. Consensus was achieved for 75.3% of the ICF categories included in the Comprehensive ICF-CS, and 100% of those in the Brief ICF-CS. These results are in line with those obtained in the validation study from the perspective of psychiatrists, where all the categories of the Brief ICF-CS and 90% of those in the Comprehensive version yielded consensus. The fact that there are also some differences in emphasis between psychologists and psychiatrists highlights the importance of considering different professional points of view in order to achieve a fuller picture of how functioning is affected in this population. Taken together, these results suggest that the ICF-CSs for schizophrenia provide a clinically relevant framework for organizing information about this health condition. Having a basic set of categories that addresses a particular patient population at different stages of an illness and that helps both to improve communication within multi-professional teams and to guide the management and treatment of patients by different health professionals is important for ensuring optimal care [ 47 ]. The ICF-CSs for schizophrenia can be used as a standard set of ICF categories to facilitate the assessment of functioning in real-life clinical practice by using the ICF qualifiers, which are codes used to record the extent of functioning or disability in a domain or category, or the extent to which an environmental factor is a facilitator or barrier. Importantly, improvement and decline in aspects of functioning can be displayed in a functioning profile over the course of treatment or over the life span. The ICF-CSs for schizophrenia may also be used as a framework for analyzing the content of patient-reported outcome measures or to inform instrument developers about what needs to be included in tools designed to assess the functioning of persons with schizophrenia. Further validation studies from the perspective of other professionals (i.e., nursing, occupational therapy, social work, and physiotherapy) are now needed in order to complement the present findings and to move a step closer towards a definitive version of the ICF-CS for schizophrenia.

Supporting information

S1 text. survey questions (round 1)..

https://doi.org/10.1371/journal.pone.0217936.s001

S2 Text. Acknowledgments.

https://doi.org/10.1371/journal.pone.0217936.s002

S1 Table. Body functions component.

https://doi.org/10.1371/journal.pone.0217936.s003

S2 Table. Body structures component.

https://doi.org/10.1371/journal.pone.0217936.s004

S3 Table. Activities and participation component.

https://doi.org/10.1371/journal.pone.0217936.s005

S4 Table. Environmental factors component.

https://doi.org/10.1371/journal.pone.0217936.s006

S5 Table. Personal factors component (proposed categories).

https://doi.org/10.1371/journal.pone.0217936.s007

Acknowledgments

The authors would like to thank all the participating experts for their commitment and the time spent, without which the study would not have been possible. Further information about the experts who formed part of this study is available as supplementary data ( S2 Text ).

• 1. World Health Organization (WHO) | Schizophrenia. In: World Health Organization. World Health Organization; 2016.
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• 3. American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5). American Psychiatric Pub; 2013.
• 11. ICF; World Health Organization. International Classification of Functioning, Disability and Health: ICF. World Health Organization; 2001.

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• Published: 08 November 2023

Conceptualizing a less paranoid schizophrenia

• James Long 1 &
• Rachel Hull 2  

Philosophy, Ethics, and Humanities in Medicine volume  18 , Article number:  14 ( 2023 ) Cite this article

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Schizophrenia stands as one of the most studied and storied disorders in the history of clinical psychology; however, it remains a nexus of conflicting and competing conceptualizations. Patients endure great stigma, poor treatment outcomes, and condemnatory prognosis. Current conceptualizations suffer from unstable categorical borders, heterogeneity in presentation, outcome and etiology, and holes in etiological models. Taken in aggregate, research and clinical experience indicate that the class of psychopathologies oriented toward schizophrenia are best understood as spectra of phenomenological, cognitive, and behavioral modalities. These apparently taxonomic expressions are rooted in normal human personality traits as described in both psychodynamic and Five Factor personality models, and more accurately represent explicable distress reactions to biopsychosocial stress and trauma. Current categorical approaches are internally hampered by axiomatic bias and systemic inertia rooted in the foundational history of psychological inquiry; however, when such axioms are schematically decentralized, convergent cross-disciplinary evidence outlines a more robust explanatory construct. By reconceptualizing these disorders under a dimensional and cybernetic model, the aforementioned issues of instability and inaccuracy may be resolved, while simultaneously opening avenues for both early detection and intervention, as well as for more targeted and effective treatment approaches.

Schizophrenia is one of the oldest and most studied mental disorders within the history of psychological science. Mental and medical health practices consistently fall short for patients diagnosed with schizophrenia spectrum conditions. Treatment plans are predominantly stereotyped, heavily reliant on second-generation antipsychotics [ 1 , 2 , 3 , 4 ], and rarely include validated psychosocial or psychotherapeutic interventions [ 5 , 6 , 7 ], Verdoux et al., 2010). This pattern persists despite widespread agreement on heterogenous presentation and treatment outcome [ 3 , 8 , 9 , 10 , 11 ], moreover, a tremendous amount of the variability in prognosis, etiology, and even the effectiveness of pharmacotherapy is accounted for by factors overlooked in diagnosis and/or outcomes monitoring [ 10 , 12 , 13 , 14 ]. This poses an ethical issue in that, to the extent that the goal of the mental health field is to alleviate human suffering and to promote human flourishing, past and present approaches miss the mark. This also implies that the currently accepted conceptualization(s) of schizophrenia spectrum disorders is at least partially flawed. Finally, this treatment failure incurs a heavy social and economic cost. The US domestic economic cost of schizophrenia is staggering, estimated at US$60 billion per annum [ 15 ], moreover, accounting for indirect costs, this is likely a conservative estimate.

The reasons for this systemic deficiency are as diverse as the schizotypy spectrum itself, ranging from foundational flaws in the current diagnostic model of mental health to constraints inherent in the contemporary mental health system. The increase in biologization of the field [ 16 ] has encouraged efforts to identify neural correlates in line with a disease model, while the preponderance of evidence indicates that schizotypy, in all of its manifestations, is profoundly moderated by environment. Such emphasis on materialism has not mitigated stigma or improved treatment outcomes and likely contributes to the current and historical plight of the population [ 5 ]. Accounting for the schizotypal population as a whole, it may be appropriate to conceptualize schizophrenia as “the story of the way that poverty, violence, and being on the wrong side of power drive us mad” ([ 17 ], p.197), or perhaps more succinctly, “bad things happen and can drive you crazy” ([ 3 ], p. 145).

Housing the etiological locus solidly within the realm of environment and not genetics is consistent with the Hearing Voices Movement (HVM; [ 18 ], which seeks to reframe psychosis symptoms within culture and context, and refrain from treatment of those experiences as a “biogenetic disease state,” [ 18 ], p. 134) which is not supported by recent data. While the model and perspective proposed in this paper aspire towards a new operational explanation, the body of research necessary and sufficient for such a definition is either nascent or theoretical,nonetheless, there exists precedent for de-stigmatizing and de-pathologizing psychosis (the symptom) and schizotypy (the syndrome).

The heterogeneity of presentation and treatment outcome has lead other researchers to argue that the construct of schizophrenia as a whole needs to be reconceptualized [ 3 , 18 , 19 , 20 , 21 , 22 ]. Inasmuch as disagreement may be attributed to the unknowns inherent in any scientific dispute, the issues around schizophrenia are more pronounced. This is likely due to numerous factors. The foremost being that all issues involving psychosis lie contrary to the unspoken morality of post-enlightenment societies, the overarching dogma of which describes a world which is ultimately without contradiction, and which can only be truly understood through the mechanisms of reason. The second unspoken assumption is that such an understanding is unquestionably good. Given the ubiquity of instrumental rationality as final arbiter of value, the ability to participate in consensus reality becomes a measure of one’s human worth, and one’s divergence from said explanatory consensus is an index of one’s illness. This cultural and methodological axiom thus doubly binds the schizotype, as their phenomenological position is simultaneously given an unspoken moral dimension while providing tools for study and care predisposed to pathologize and dispense with said position as inherently aberrant and symptomatic.

The present article will begin with rationale explicating the historical, philosophical, and conceptual difficulties precipitating myopic approaches to treatment and research within the population. Secondly, it will survey relevant evidence from various disciplines which provide converging evidence toward a more comprehensive view of schizotypy and its manifestations with psychotic features. Finally, the present authors propose a more thorough conceptualization of the schizotypal spectrum, along with a framework to reconceptualize schizotypal diagnoses as identifiable patterns within a dimensional paradigm incorporating both “healthy” and “pathological” members. Finally, clinical implications will be discussed.

Ultimately, it will be argued that a properly developed cybernetic model, rooted in trauma-informed personality theory, best captures the nature and breadth of this human experience. It is the present authors’ hope that with such a reconceptualization, self-stigma in those with schizophrenia will mitigate as well, as self-stigma in individuals on the schizotypal spectrum has been recognized as a “second illness” [ 23 ], as cited in [ 3 , 24 , 25 , 26 , 27 , 28 , 29 ].

Historical and philosophical precedents

Underlying axioms and paradigmatic blind spots.

Although there is room to debate many of his specific points and inferences, Foucault (1965) addressed many of the genealogical ideas that underlie current mental health practice. Salient are the social and moral implications of mental illness in a post-enlightenment age. Reason and empiricism were held up as the means by which humanity would extract itself from the arbitrary and oppressive moral and social systems that characterized the preceding epochs. However, as no human or society can exist without an orienting value system (ought from is) [ 30 ], this revolution merely altered the parameters. Moral punishment became reserved for “healthy” individuals with deviant behavior, while those whose behavior was determined to be medical in origin were to be cured (i.e. brought back to reason and regulated passions). However, in both cases it was deviance from the collectively understood “good” which was targeted. In the former case, deviant behavior was punished or corrected through learning, while in the latter psychological deviance imbued society with a moral duty to treat or cure. Much of our current approach to treatment, such as cognitive-behavioral theory, is predicated on this idea, that it is irrational thoughts that cause distress, based on the underlying assumption that showing the person that their thinking is irrational is itself a kind of cure for their experience.

In a recent review of 30 consecutive court-mandated medication hearings, 29 were approved without a jury, most in cases where serious neurological damage had been caused by medications and at higher doses than would be recommended. All cases of treatment had entirely discounted options such as psychotherapy, despite defendant and family protest, demonstrating that the line between moral capability, medical impairment, and societal responsibility is still quite blurry [ 5 ].

The presenting issues involving psychosis are inherently aberrant against the axioms of the age, giving their expression a numinous quality absent from comparable symptomology. While a “healthy” person can empathize with a depressive or obsessional person (seeing their experience as merely an extreme version of their own), the hallucinations, delusions, disorganized thoughts, and behaviors of psychosis are deeply unsettling. Such a person may be pitied or sympathized with, but how can one empathize with a person who is not participating in consensus reality, let alone take their perspective seriously?

The rational-empirical model Foucault was dissecting had more comprehensive effects as well, establishing the parameters by which reality was defined. Truth was to be determined through careful observation, data collection, and objective analysis of results. One could subsequently remove the confounds of arbitrary values and subjectivity and determine what was and was not “real.” This idea has been one of the most important and useful tools in human history, and its benefits cannot be overstated; however, as with any idea, it rests upon axioms and results in outcomes with predictable constraints.

As much of the unspoken paradigm scaffolding within scientific models can be traced back to the ideas of rationalism and empiricism, and to the extent this paper aims to address axiomatic flaws in those models, it is worth exploring the concepts. Broadly speaking, the rationalists argued that knowledge was attained through logic and reason and that human understanding was founded on innate ideas. In contrast, the empiricists argued that humans were tabula rasa, and that knowledge was gained exclusively through sensory experience. Responding to both, Kant [ 31 ] outlined his synthetic a priori propositions on reason and its recognition of necessary cognitive structures preceding sensory modification. He argued that the only way in which a human being could have knowledge in a functionally infinite sea of data was through categorization. That we contained an innate scaffolding which predisposed us to select and judge our sensory data, and that without such we could not possibly perceive the world in any meaningful way at all. Moreover, as we were goal-oriented creatures, this was an inherently value-laden conceptualization. While this perspective was revolutionary in overall enlightenment thinking, its ultimately phenomenological approach to reality has had little impact on the scientific endeavor to understand that very rationality.

What has been retained is something of the desire which drove Kant’s deductive exploration; namely to arrive at a surety of knowledge without call to a divine authority. His endeavors into synthetic a priori knowledge assumed and ultimately sought to prove that foundational sure knowledge could be found and worked upwards from to arrive at universal and objective truth. The distillation of this is the reductionism which subtly underlies scientific inquiry to this day; the belief that the best way to understand a complex system is to break it into its smallest constituent units and then extrapolate upwards. From this we may identify the roots of the atomism and materialism which will be discussed further in this paper.

Equally important to these methodological axioms however is the subtle implications of a unitary truth when applied to the psyche and its inquires (i.e. that a single correct perspective is attainable and thus deviation therefrom is an error to be corrected). Through this lineage one has dispensed with subjectivity (the valuing ‘ought’ and its many constraints) in favor of objective proxies as a means of study and have thus over time, often with a sense of moral duty, come to see subjectivity as (at best) epiphenomenal. This trend has likely reinforced, if not outright caused, the current preference for biological interventions for subjective experiences while viewing aberrant subjectivities as a problem to be solved. The more strictly empirical approach can likely be attributed to the structural disconnect between verifiable data and subjective experience endemic to objective and materialistic approach to science; however, this inattention has created potential blind-spots in investigative assumptions.

Congruent models and fractal patterns

While Kant arrived at his categorical phenomenological conclusions from deduction and intuition, Jean Piaget [ 32 ] outlined a nearly identical process by observing the developmental construction of schemata in young children. In highlighting the evolution of children’s reports and understandings of reality, Piaget stands as a kind of naturalist of the same process proposed by Kant, in which a rather simple set of structures give rise over time to the operations of intelligence. In both Kant’s concept of understanding and Piaget’s concept of a schema (in a total sense), a person can only conceive of realities congruent with the structure of their framework,that is, they have a subjective perspective. Where Piaget’s observations stand out is in his detailing of the process by which these structures update and organize themselves across time (e.g. the famous cognitive revolution children experience when developing a theory of mind). In light of contemporary evolutionary, genetic, and personality research though, the full scope of potential schematic diversity remains an open question. That is, to what degree do we converge upon a universal perception of reality and to what degree are we perceiving and conceptualizing differently?

Regardless, the implication of the symptom-focused taxonomy of the DSM or ICD is that subjective diversity is either irrelevant or non-existent and thus our scientific study of the mind cannot account for it. Given that our schemata expand and evolve through assimilation and accommodation, and that they are the medium through which we construct our reality, the means by which that dynamic equilibrium is affected by biological predisposition and the specific nature of events experienced during this process must be accounted for if psychology is to succeed as a scientific pursuit. Understanding the forces which led to and maintain such an equilibrated structure carries implications for psychological models of cognition and perception as well as for clinical treatment.

Symmetrical to Piaget’s schemata, Kuhn’s [ 33 ] description of the paradigmatic nature of scientific discovery demonstrates this process at the level of consensus reality and may also indicate the core problem with current models of schizophrenia-spectrum disorders. Much in the same way a developing child in Piaget’s model works pragmatically within a ‘good enough’ schema until sufficient development and anomalous information induces a reorganizational (and thus perceptual) classification, Kuhn noted that scientific paradigms (collective schemata of interpretation and behavior) progress until sufficient anomalous data induces a reorganization of core assumptions, such that previous evidence and anomalous evidence remain, are accounted for, and explained. Much as two individuals with incompatible schemata would find mutual understanding impossible without accommodation on one or both ends, the current paradigms informing much of psychological research (e.g. objectivism, materialism, etc.) cannot account for the symptomatic manifestations of the schizotypal spectrum other than as pathological deviation, and thus remain obtusely focused. Instead, models must account for the biological and environmental impacts on schematic development as a necessary component in any defensible definition of mental health. Currently, models such as the Five-Factor Model of personality (FFM); [ 34 ] offer avenues to begin exploring and discussing this scientifically, however their implications have yet to meaningfully propagate throughout the psychological field.

Outcomes and limitations of unexamined axioms

In a discussion on the theoretical challenges facing psychology today, Slife (as cited in Lambert, 2004) identified numerous constraints on theory and its practical application. Objectivism essentially posits that the logic inherent in the methods and techniques of science and clinical practice can be relatively free of systematic biases and values. This is achieved through the use of logical reasoning (rationalism) and unbiased observation of phenomena (empiricism). This permits a certain unbiased standard of proof that can be verified and agreed upon without appeal to arbitrary authority or preconceived assumptions; however, it also leads to limitations. It bounds what can be studied (and thus proven) to those things which can be observed and replicated. In psychology, this translates to examining the psyche by proxy. As one can have no direct observation of experience, various behaviors are examined instead with the assumption that these act as indicators of internal states and dynamics. Where behaviors cannot be determined, states are operationalized; anxiety becomes the nexus of racing thoughts, restlessness, distractibility, etc. What cannot be captured is the valence, meaning, and experience of anxiety, or the idiosyncratic relationships an individual's anxiety has with their own history, conceptual framework, and day-to-day experience.

For example, within a psychodynamic framework, a clinician would find it important to determine whether a patient’s depression was anaclitic or introjective, thus accounting for the inner subjectivity underlying the overall state. However, most strictly empirical research and certainly most pharmacological research must measure itself by symptom reduction within the DSM criteria of depression, which does not account for personality style. In this way, the methods by which research is conducted systemically deem irrelevant domains of human experience and psychological evolution, becoming blind to them.

A second axiom is materialism, which posits that psychological experiences will eventually be shown to have observable and biological bases. All psychology is simultaneously biology. As with objectivism, this assumption is predominantly benign or beneficial; however, it too creates complications. One is the implicit causal direction; that the core problem is contained within, and thus solvable and explicable through, biology. Indeed, materialism is tightly wedded to objectivism as it is often far easier to study physical systems than social or psychological ones. This belief underlies much of the faith in and reliance on pharmaceuticals as “cures” for psychological disorders. Once a biological correlation is identified, it is treated as the cause despite our knowledge that the relationship is more complicated; moreover, the entire DSM/ICD classification systems assume biologic etiology. This causal direction also promotes an aura of preeminence to biological markers over holistic biopsychosocial assessment. For example, if research finds that serotonin differences act as a biomarker of depression, it is assumed that such differences causally precede the psychological state and so become the target of treatment, despite evidence that such neurotransmitters are themselves greatly influenced by environment and cognitive framing [ 35 , 36 ].

Finally, the axiom of atomism assumes that the qualities of people are contained within the individual, and so treatment should focus on individual cognition, biology, and behavior. As can be seen, atomism dovetails seamlessly with reductionism (the individual is the indivisible member of the collective), materialism (the biological operations of others do not influence those around them), objectivism (it is easiest to observe the components of an individual rather than the network of influences between them and their environment over time) and implicit morality (the locus of choice and thus moral human agency exists within the individual). These assumptions, while almost certainly a necessary heuristic, can lead researchers and practitioners to underestimate or ignore the impact of relationship factors or social context.

These and other axioms inform many more areas of human life than the field of psychology, and in many of them (e.g. particle physics), they may operate more or less perfectly. Inasmuch as psychology is to be the study of the psyche, however, it must at some point include the study of human subjectivity; moreover, it is the experience of suffering that we aim to alleviate, not its proxies. This is decidedly difficult within a framework that goes to great lengths to remove all subjectivity before even beginning its search.

Furthermore, whatever it is one means by the psyche, it is a dynamic and multi-level phenomenon. It is shaped by the past through memories and biological alterations (processes which continue to change throughout the lifetime); simultaneously, how a person conceives of the future continuously alters behaviors, cognitions, and relationships (which in turn recontextualizes memories and alters biology). Each of these is further informed by the idiosyncratic relationships a person has (as well as how he conceives of them) and the environment in which he lives (physical and social). It is in fact this entire set of inter-penetrating and interlocking systems which determine how any particular experience manifests. Within the framework above, those elements which are most difficult to operationalize or which lie perpendicular to accepted rigor are granted a reality significantly less substantial than those which are considered more “evidence-based,” and thus most often lay unaccounted for in final etiology and nosology.

The DSM’s taxonomy, as well as its preeminence in mental health practice, is the distillation of this process. It testifies to the strengths this approach has brought to the field, and simultaneously contains its weaknesses. As has been noted by clinicians throughout its development and subsequent iterations, the DSM’s approach dispenses with, misinterprets, or lies contrary to the bulk of historical and contemporary clinical wisdom [ 37 , 38 , 39 , 40 ].

Without an explicit definition or discussion of mental health, the DSM implies that the removal or reduction in stated symptoms is the goal (empiricism and reductionism). This creates the following three issues: (1) While symptom relief may be desired, no other medical professional would equate symptom reduction with a cure. (2) The DSM can offer no discussion or guidance on important qualia within those symptoms (e.g. recall objectivism—is the depressive experience fundamentally anaclitic or introjective). (3) The DSM offers no insight on the depth of, interactions between, or potential functions of experiences as outlined. One may contend that none of these was meant to be the function of the DSM, which was instead intended to be one tool in an arsenal the clinician would bring to bear. However, whether due to the constraints of time and energy, the demands of insurance companies, the limitations of training, the (above-outlined) biased nature of research, the fact that the DSM is subservient to the ICD, or any combination of these factors, it is often the case that the DSM is used in exactly this manner. In 2013, the National Institute of Mental Health (NIMH) ceased funding DSM-based research citing the model’s overall “lack of validity” (Insel, as cited in [ 41 ], p. 522).

The weight of evidence accrued even within this framework calls its assumptions into question. It has been noted, for example, that in clinical settings, depression is usually paired with anxiety and somatic symptoms, while also manifesting in highly variable ways (aggression, risk-taking behaviors, etc.) [ 39 ]. Simple diagnosis is insufficient for treatment planning [ 42 ] and ultimately leads to stereotyped and imprecise responses; moreover, if disorders were, in fact, distinct categories, one should expect them to have distinct boundaries with matched biological correlations. However, antidepressant medications are used to treat anxiety and other mood disorders, and antipsychotic agents are prescribed for bipolar disorder and various severe personality disorders. Symmetrically on the treatment side, cognitive-behavioral therapy (developed to address internalizing disorders) has since expanded to encompass nearly every class of mental disorder [ 43 ], despite major methodological flaws in the research that supports CBT [ 44 ]. Moreover, longitudinal and epidemiological evidence indicates that etiology, prognosis, and even pharmaceutical effectiveness depend on psychosocial factors disregarded in the current taxonomy. For example, in patients with schizotypy and psychosis, treatment and pharmacological outcomes depend much more on factors such as childhood trauma, social factors, and neurocognition [ 3 , 11 , 45 ].

While the full impact of this dynamic stretches throughout the whole of psychology, select points are particularly relevant. In striving toward the objectivity so highly valued under our society's ruling metanarrative, psychological practice and research has adopted, almost axiomatically, a “disease” model of psychological suffering; we document symptoms and attempt to place them into distinct categories which would have distinct biological/behavioral underpinnings which can be discretely addressed. Thus, the experience of a disorder and its treatment can be generalized and divided into discrete components. It also implies that, as the symptom expressor, the problem lies within the individual and so must be addressed at that level. As was outlined through underlying Enlightenment philosophies earlier, these assumptions are natural outcomes; that the moral locus lies within the individual’s own rationality (their claim to full personhood) and so remains unquestioned within most research models. As Higgs [ 18 ] purported, “the advancement of neoliberal values and policies likewise favors naturalizing inequality through the lens of biology, locating the suffering caused by social problems within individual bodies, which are perceived as self-contained and (ideally) fully independent” (p. 138).

Given that such a model is conducive to research, conforms well to the needs of insurance and pharmaceutical companies, and carries the implied authority of decades of acceptance, the situation is self-reinforcing. Moreover, the taxonomic model implies a baseline human experience, deviation from which constitutes the nature of psychopathology. Given biologization and atomism, the problem is seen as localized within the person, and treatment focuses on the adjustment of biological systems and the resolution of irrational thoughts and behaviors. In so doing, the complexity of human psychology and the entirety of subjectivity is done away with; a serious issue given that the psyche is defined by and experienced through subjectivity. Indeed, “a grisly tradition of ‘biologizing social facts’ exists within psychiatry” [ 18 ], p. 137–138). This divides much of psychology as a body of knowledge from the bulk of clinical wisdom and makes the training, expansion, and transmission of this understanding difficult at best. It limits the field’s understanding of human psychology and our ability to address individuals’ actual experiences. For example, in addition to the model’s inability to discuss characterological differences or dynamic interactions between disorders and psyche, it has nothing to say about the positive side of human experience as a necessary component of health. Finally, while this complex is problematic for any psychological disorder, it becomes more so the more deeply and/or longitudinally it exists within the client, and the further from placidity, conformity, and rationality it takes her. A person experiencing an anxiety attack has a problem, a person with borderline personality disorder needs extensive management, and a person with schizophrenia is beyond the pale.

Philosophical summary and subsequent steps

The broad philosophical assumptions which form the basis for the rational-empirical model informing current scientific inquiry have given primacy to objectivity as the measure of truth as a matter of course. In so doing, it has ultimately directed research and our collective understanding of psychology into a taxonomic and symptom-based structure which will naturally prioritize biological causation and atomistic approaches to treatment. Simultaneously, the same axioms which dictate our current scientific paradigm contain implicit moral assumptions which reflexively pathologize experiences, perspectives, and expressions which are deemed “irrational,” regardless of whether they are themselves the source of distress. This interaction has led to an overall approach to psychological research and treatment which stigmatizes patients (particularly those on the schizotypal spectrum) while concurrently falling short in developing effective treatments and models due to inherent methodological flaws; despite clear evidence that current taxonomies are unstable and that the assumed biological mechanisms underlying them do not align with their framework. Moreover, given the shared genealogy of both these processes, they are self-reinforcing and inherently perpetuated through the systems and approaches they generated. Without a revolution within the paradigm (systemic schema), psychology as a whole will struggle to fully grasp its subject matter (the psyche). Much as in Piagetian models, it is the failure of schemata to account for experience through assimilation that sparks accommodation. Current evidence from within our paradigm indicates a similar process needs to occur to progress. Thus, developing a full conceptualization of schizotypy requires an act of decentralization and a re-examination of the current body of evidence as a whole if the field is to mature.

In contrast to categorical approaches, current evidence suggests that adopting a cybernetic model better captures the complexity of the phenomena, the etiology of pathological development, and ultimately offers insight into the phenomenological bases of and treatment approaches for the schizotypal population. Briefly, cybernetic models seek to map the behavior of complex self-regulating systems. The mathematician Norbert Wiener defined cybernetics as the study of “control and communication in the animal and the machine.” [ 46 ] and noted its applicability to biological systems, computer systems, and broad organizational structures such as governments. What must be understood is that within a cybernetic model, a number of interlocking processes exist within a network of mutually influential relationships. Such systems are reactive and attempt to reach equilibrium through alterations in one or more of their domains. In the case of small disturbances, a cybernetic system may merely make a minor adjustment in one domain to achieve homeostasis; however, in cases where a sufficiently large disruption occurs, the system as a whole may reorganize into an entirely novel point of balance. In such systems, feedback loops between systems are conceptualized; accounting for how over time relatively minor interactions can reinforce and strengthen each other sufficiently to cause such a restructuring. It should be noted the conceptual resonance such a framework has with Piagetian schemata, Kuhnian paradigms, and many psychodynamic conceptualizations of personality development.

With this in mind, the following sections will begin outlining relevant insights gained across a number of disciplines outlining the qualities of the proposed schizotypal population and suggesting the important factors contributing to the development of experiences such as schizophrenia.

The Schizotypal spectrum within categorical models

While schizophrenia spectrum disorders have been recognized categories of pathology for many decades, the debate about whether there is an underlying genotype or phenotype which preceded each disorder is ongoing. Indeed, there are larger limitations in the assessment of schizophrenia spectrum syndromes than any assessment’s individual construct validity. These are understandable, due to the disorder’s complex etiology and overall institutional focus on diagnosis as a starting point. Given the vast number of contributing factors both preceding and subsequent to formal diagnosis, capturing the most salient dimensions of any particular patient’s experience requires a long list of assessments and extensive clinical interviewing. That is, if there were a healthy population out of which schizophrenia spectrum disorders arise, one cannot know their characteristics except perhaps through post-hoc inference as assessments capture only symptoms of the most extreme pole of disorders. Currently, there is no comprehensive assessment covering all or even most of the domains noted through clinical research and experience. As such, developing an informed treatment plan would demand a complex exploratory phase and numerous specific follow-up assessments to achieve reliable effectiveness; however, given the stereotyped nature of current schizophrenia treatment [ 1 , 2 , 3 , 4 ], such a comprehensive assessment would likely be too unwieldy for clinical use, or so broad as to merely perpetuate the problem.

Despite this, the schizotypal spectrum exists implicitly as an entire chapter in the DSM (though syndromes are arbitrarily demarcated) in the temporal evolution from brief psychotic disorder through to formal schizophrenia. In contrast, the autism spectrum exists as a single F-code with level of impairment handwritten in (Levels 1–3). At the present moment, the field appears to be quite confused as to how to understand the schizophrenia spectrum. This factor remarkably complicates assessment. Despite diagnostic confusion, known empirical correlates exist with MMPI3 and Rorschach, for example; however, such correlates exist for personality traits [ 47 ], Mondal & Kumar, 2021), which may be helpful in diagnosing shizoid PD and schizotypal PD, but less helpful for a brief psychotic episode all the way through to formal schizophrenia. One’s transient state greatly impacts presentation, a second complicating factor of assessment. Thirdly, scales on the MMPI such as Scale 8 (entitled “Schizophrenia” on the MMPI2) and Restructured Clinical Scale 8 (RC8; entitled “Bizarre Ideation”) on the MMPI3 do a fine job gathering data on positive symptoms, as does the Achenbach System of Empirically Based Assessment’s “Thought Problems” subscale [ 48 ], however, negative symptoms are easier to overlook and possess a more abstract developmental quality. This is decidedly problematic given the evidence that it is negative symptoms which most influence the etiology and the treatment of schizophrenia spectrum disorders [ 49 , 50 , 51 ].

Toward issues around diagnosis the problem is even more obtuse. As the current diagnostic model requires the presentation of 2 or more serious symptoms such as hallucinations or delusions for a significant period of time and persistence of disturbance for six months [ 8 ], clinicians are caught in an orientation of triage, approaching the problem after the fact. While the DSM-5TR does imply a manner of progression from brief psychotic disorder to schizophreniform disorder and finally schizophrenia, this interpretation also focuses on the presentation of the most extreme symptoms, creates an observational perspective (altering diagnoses as various milestones are reached), and ultimately fails to properly account for the broad heterogeneity of patient presentation and differential reactions to treatment [ 52 , 53 ].

It is an essential theoretical assumption that underlies the current paper that these categories more accurately represent extreme presentations along a spectrum of “schizotypy”; essentially, a spectrum which manifests diversity in presentation. Similar models already exist within psychology [ 54 ], as does the overall diagnostic mindset (e.g. identifying and treating those on the autism spectrum). It is believed that the spectrum framework better accounts for the heterogeneity of presentation and treatment outcome within the population with implications for more accurate prognosis and effective treatment. This also normalizes and contextualizes the variability and range of symptom expression. Said normalization carries not only ethical implications but also suggests dimensions of treatment that offer increased dignity and resilience to those currently experiencing the spectrum’s most distressing presentations while simultaneously opening avenues for pre-morbid interventions to prevent many otherwise healthy schizotypal individuals from experiencing said distress and its accompanying stigma. Indeed, “because the incontrovertibly psychotic diagnosis of schizophrenia fits people at the disturbed end of the schizoid continuum, and because the behavior of schizoid people can be unconventional, eccentric, or even bizarre, non-schizoid others tend to pathologize those with schizoid dynamics” [ 55 ], p. 196). Schizotypes find themselves in a double-bind: those with poor insight often have poor outcomes, and those who possess high insight are frequently besieged with depression, low self-esteem, and suicidality [ 56 ]. Thus, developing a comprehensive and destigmatizing model is an essential element in treating the population.

The presence or absence of psychosis is not an appropriate criterion measure of a distinct schizophrenia spectrum condition, nor is it deviant or divergent. Approximately 7% of the general population will have a psychotic experience within their lifetime. Of those 80% will be transitory, with only 7% going on to develop a psychotic disorder [ 21 ]. Psychotic experiences are also transdiagnostic and thus may be inappropriately conceptualized as unique to schizophrenia. “It is only when high levels of schizotypy are combined with other aetiological risk factors that an individual may be considered at risk for schizophrenia and other psychotic disorders. According to this perspective, unless high schizotypy is combined with other risk factors, it is considered neutral in regards to psychopathology” [ 57 ], as cited in [ 20 ].

The overall focus on psychosis (and, its “irrational” positive symptoms) is an axiomatic bias. However, there is empirical and clinical evidence that a population exists which is predisposed to psychotic experience and more likely to do so for much longer periods of time. If true, two questions must be answered. Firstly, what are the qualities which define this population and how do these qualities relate to psychotic experiences? Secondly, what factors (internally and externally) select some members for pathological expression?

Dimensional models

Spectra of phenomenology.

There is significant evidence supporting a dimensional reframing of psychological disorders [ 3 , 39 , 40 ]. During DSM–5 field trials, 40% of diagnoses did not meet cutoff for acceptable interrater reliability (IRR). Operationalized dimensionally, the same disorders achieved excellent IRR [ 39 ]. A dimension, in this context, is a psychological continuum stretching from the average range to extreme expression. It is the individual’s degree along a dimension and his specific dimensional interactions that ultimately lead to the higher order complexes addressed in psychotherapy.

The Hierarchical Taxonomy of Psychopathology (HiTOP) model, for example, describes ascending levels of complexity beginning with dimensions and rising through components, traits, syndromes, subfactors, spectra, and super-spectra. In such a conceptualization, an individual traditionally diagnosed as having depression, anxiety, and an attentional disorder is understood instead as having an interlocking network of specific and interacting anxiety, avoidant, and/or internalizing dimensions. Ultimately, a dimensional framework addresses many of the problems within categorical models, including heterogenous presentation, comorbidity, diagnostic instability, and unstable boundaries with normal psychological functioning, all while having a much stronger empirical basis [ 39 , 40 ].

In research on schizotypy and psychoticism, strong evidence exists that individuals manifesting these disorders instead represent a small cross-section of a more diverse psychological phenotype within the general population. As was noted, clinically significant psychotic experiences are not uncommon in the general population [ 21 ]. In a six-year general population study, it was found that subclinical positive psychotic experiences themselves were insufficient to predict transition into clinical disorder; alternatively, it was the presence and persistence of environmental factors such as childhood trauma, developmental problems and ethnic minority status, as well as severity of secondary distress due to these experiences that best predicted a disorder status [ 3 , 48 ]. Most individuals with psychotic experiences also carry an additional diagnosis (most often a mood disorder), and the presence of such a disorder is highly predictive of poor prognosis [ 21 ]. This is consistent with epidemiological research indicating that the negative symptom dimension (such as poor emotional expression and avolition) is a strong predictor of outcome measures, including the need for treatment at all [ 58 ].

As any phenomenology is reactive to its environment, it can be understood how stressful and traumatic experiences can begin altering patterns of cognition and behavior along such dimensional lines. While the more extreme presentations along the schizotypal spectrum (catatonia, flat affect, delusional thinking, etc.) may appear entirely unique, they are not inconsistent with trauma research. Those suffering traumatic or sufficiently stressful experiences often display magical thinking, irrational narratives, affectively-driven reactions incongruous with present reality, and behavioral tendencies towards withdrawal, explosive externalization, and somatic behavior [ 59 , 60 ]. Moreover, such experiences also create neurological and biological changes quite consistent with those in schizophrenia [ 61 , 62 , 63 ]. Thus conceived, even the most extreme presentations within the spectrum can be rooted in explicable and often even beneficial human behaviors and predilections, merely pushed beyond their capacity for stress.

Given the above, there is reason to believe that much of the current conceptualization of schizotypal individuals suffers from a kind of survivorship bias. That is, research is conducted and models are created based on those individuals already in sufficient distress to seek help, and in attempting to reverse-engineer an etiology, the most unusual symptoms are given priority. However, while the presence of positive symptoms such as hallucinations or delusions can certainly be distressing on their own, evidence suggests that these symptoms are acute responses to internal suffering and environmental stressors and rarely, if ever, rise to the level of clinical significance outside of prolonged and unresolved stress [ 48 , 64 , 65 , 66 ]. From a dimensional perspective, any psychopathology is understood as a dynamic interaction of symptoms influencing each other over time. Thus, in the earliest stages of an “illness,” symptoms are diffuse. Specific syndromes manifest only after prolonged influence and interaction. The specific expressed disorder depends on the nature of the stressors, the developmental stage in which they appeared, and their duration [ 48 , 66 ]. Equally or more important is the individual’s idiosyncratic response style based on differentiation of dynamics between mental states [ 48 ].

To reframe the problem in terms of the overall philosophical blind spots outlined earlier: In trying to understand the nature of schizophrenia so late in its etiology, those elements which seem most alien to our implicit beliefs about mental health are accepted as descriptive of and central to “the problem.” Consequently, we ignore those elements driving the observed symptoms, and subsequent treatment becomes mere management of those symptoms most distressing to norms and caretakers. This may be necessary when a schizotypal individual’s perceptions and thought patterns create distress, isolation, or additional issues; however, it is insufficient to claim that merely subduing these expressions is equivalent to successful treatment, if the underlying sources of stress, maladaptive defenses, and/or relational/attachment experiences remain.

Personality organization and clinical understandings

In her discussion about schizoid personality structure, McWilliams [ 55 ] limned its key traits from a psychodynamic perspective: (1) schizotypes are easily overstimulated and report the experience of their own and others’ affect as overwhelming (p. 198), (2) often perceive the world as threatening to damage or distort their individuality and security; “A deep ambivalence about attachment pervades their subjective life. They crave closeness yet feel the constant threat of engulfment by others; they seek distance to reassure themselves of their safety and separateness yet may complain of alienation and loneliness” (p. 201). (3) As favoring the defense of withdrawal (e.g. into fantasy or physical isolation) while often lacking many of the more common defenses (though projection, introjection, idealization, devaluation and intellectualization are not unheard of); “Under stress, schizoid individuals may withdraw from their own affect as well as from external stimulation, appearing blunted, flat, or inappropriate, often despite showing evidence of heightened attunement to affective messages coming from other” (p. 200). (4) they often speak and act in eccentric and non-conforming ways and may have a natural reliance on metaphor, symbolism, and creative expression when conveying thoughts and experiences; “Even when they see some expediency in fitting in, they tend to feel awkward and even fraudulent making social chitchat or participating in communal forms, regarding them as essentially contrived and artificial” (p. 204).

Applied under a dimensional framework (not incongruous with psychodynamic concepts such as defense mechanisms) the above qualities lead to a probability field of likely dynamics. For example, a person who instinctually withdraws when distressed, and receives little internal reinforcement for casual social interaction, is less likely to develop robust interpersonal skills while being simultaneously forced to understand and manage their powerful affect without guidance or community. If such a person also speaks and acts in an eccentric or unusual way, while maintaining sensitivity to others’ reactions, it is likely they will develop an “othered” conception of self. It is straightforward enough to see a potential for self-reinforcing patterns of pain, expression, social failure, withdrawal, and isolation. If this combines with a penchant for imagistic/symbolic thinking/representation, an entirely separate phenomenological language could begin to develop.

Germane to the larger point is that none of these components are pathological in and of themselves. Indeed, McWilliams argued that most schizoid-organized individuals are quite functional, some even highly so. Although they may be stigmatized and misunderstood (even, and perhaps especially, within the mental health field) due to an unexamined normativity bias [ 67 ], an effective clinician should explore both the valid content within their unusual expressions as well as the characterological strengths rather than assuming them to be meaningless, aberrant, or dangerous. In fact, she noted that working with such a client may be quite pleasant as they are often well in tune with their own internal dynamics and how those influence their own experiences and broader environment.

Personality research and parallels

A third conceptually parallel line of inquiry has been conducted within the frameworks of Five Factor Model of personality theory (FFM) which offers to blend the phenomenological depth of psychodynamic understanding with the scientific rigor of empirical inquiry along dimensional lines. While debates about the structure, components, evolution, and even the ontological nature of human personality are nearly endless, FFM is notable for several reasons. From a broadly conceptual standpoint, FFM stands out in that its development was nearly atheoretical; that is, rather than being reverse-engineered from an existing psychological or culturally instantiated models of human nature, it was instead derived in a bottom-up fashion based on factor-analysis of patterns with linguistic representations. This lends a certain assurance that the model contains fewer a priori assumptions than many of the other popular models espoused. Furthermore, from a more purely empirical perspective, FFM has shown remarkable performance in research settings.

While the initial model was developed through a lexical analysis of English, subsequent studies have been performed utilizing numerous other languages (e.g. Filipino, German, Czech, Dutch, Korean, Hebrew, etc.), which have reasonably confirmed the same five dimensional structure [ 68 , 69 , 70 , 71 ]. Cross-cultural multivariate behavioral genetic analysis demonstrated that the phenotypic structure of the FFM reflected a universal genetic and environmental structure [ 72 ]. Longitudinal studies have shown temporal stability across lifetime as well as the dimensions’ antecedent impact on later psychopathology [ 73 , 74 ], and FFM research indicates that dimensions such as neuroticism and extraversion are central elements underlying the vast majority of currently designated disorders [ 75 , 76 ]. This level of construct validity is lacking in current DSM-based personality disorders [ 77 ], and as was noted earlier in this paper, is an issue with current disorder constructs categorically.

As with any living model, there are varying ways of dividing and organizing the personality dimensions depending on the area of inquiry. For example, some models explore a construct directly labeled psychoticism, while others do not. Given the modular and hierarchical nature of the model though, it largely avoids the decoherence this diversity might otherwise imply. At core, FFM postulates that personality is composed of an individual’s position along five continuous dimensions: extraversion (sociability or positive affectivity), agreeableness (compassion or cooperation), conscientiousness (diligence or constraint), neuroticism (emotional instability or negative affectivity), and openness (intellect or unconventionality). Depending on the level of analysis, each dimension can be meaningfully decomposed into sub-elements (e.g. conscientiousness may be broken into component parts of orderliness and industriousness) [ 78 ] which can then be differentiated further into even more specific facets, behaviors, and tendencies. It is worth noting that it is at this level where the chirality between FFM and dimensional models such as HiTOP comes into focus; they do not neatly superimpose when reflected over each other; FFM being a bottom-up model beginning with foundational tendencies and investigating upwards and outwards, most other dimensional models may be viewed as top-down, beginning with a psychopathological state and deconstructing it into it constituent elements and antecedents. In the latter case, explorations of experiences such as hallucinations tend to cease at the point where hallucination-like experiences do. If (as this paper postulates) such higher-order expressions are emergent properties of entirely benign faculties, then such top-down explorations will have little insight into this non-pathological domain. Where FFM shows the greatest potential as a framework is in its potential for providing phenomenologically causal explanations for behavior rooted in “normal” personality structures while offering broad avenues for research into biological instantiation.

The schizotypal spectrum has been a robust area of interest within FFM research for a number of years. Most consistently, schizotypal individuals score highly on trait neuroticism and low on trait extraversion [ 79 , 80 , 81 ]. This is unsurprising in light of previously mentioned clinical profiles and the generally accepted symptoms within current taxonomies, as negative affectivity is found to load onto the former, while detachment loads onto the latter [ 82 ]. Additionally, research has indicated that low agreeableness is a factor in positive symptoms [ 81 ] and perhaps in manifestations overall [ 83 ] and some research has implicated low conscientiousness compared to “healthy” controls [ 52 ]. Most contemporary factor research highlights specific subcomponents of each dimension (e.g. the level of trust vs. mistrust within trait agreeableness is often indicated as accounting for much of the variability). However, given the high number and variability of these, a full overview is unwieldy.

Of particular interest within FFM schizotypy research is trait openness. While studies into the personality components of psychopathologies have consistently found meaningful contributions for the first four traits, the data around openness is much more variable. This has led to some speculation that trait openness is functionally dissociable from psychological disorders [ 84 , 85 ],however, it is consistently found to be one of the best personality markers for those on the schizotypal spectrum [ 86 , 87 ]. In parallel, it has been shown to carry greater variance with PID-5 Psychoticism [ 86 ].

The construct of openness provides perhaps the best theoretical basis within FFM for understanding the positive symptoms associated with schizotypy (e.g. hallucinations, delusions, disordered thoughts/behaviors, etc.). Broadly speaking, openness encompasses intelligence and creativity, or one's interest in ideas and one's interest in aesthetics [ 86 ]. It may be meaningfully differentiated into subcomponents such as openness to fantasy, aesthetics, feelings, actions, ideas, and values, and it is tied to scores on measures such as divergent thinking and fantasy-proneness [ 34 , 85 ]. There is an obvious conceptual link between these facets and many of the positive symptoms of interest; however, much of the research looking to tie the trait to specific symptoms has delivered conflicting results [ 86 ]. Some of the conflicting findings may be accounted for by the complex nature of the trait. For example, it has been demonstrated that while interest in aesthetics meaningfully predicts variance in positive symptoms, interest in ideas/intelligence has a negative correlation with the same [ 86 , 88 ]. This finding is supported in neural modeling research demonstrating that psychoticism, openness, and their shared variance were positively related to coherence in the default network (simulation of experience rather than attention to sensory input) and negatively related to coherence in the frontoparietal cortical network (voluntary control of attention), which have each been tied to psychosis and trait intelligence respectively [ 88 ]. Further research has shown that the positive dimension is better captured by measuring the “maladaptive” poles of the traits (i.e. the extreme high and low ends of expression) [ 83 , 87 , 89 , 90 ]. Within a cybernetic model, this predictive extreme is precisely what would be expected as such extremity would require equally extreme adaptation to achieve equilibrium. Moreover, with the context of the trauma work cited earlier, one would expect that highly stressful experiences would themselves push the natural pathways of behavior into radical adaptation.

Schizotypal individuals obtain higher scores in divergent thinking [ 91 ], a trait linked to openness as well as creative performance generally [ 9 , 87 , 92 ]. Fractional anisotropy measurements of white matter integrity have shown “an apparent overlap in specific white matter architecture underlying the normal variance of divergent thinking, openness, and psychotic-spectrum traits, consistent with the idea of a continuum” [ 92 ]. As well, trait openness and creative achievement show a negative correlation with latent inhibition (cognitive shielding from information previously coded as irrelevant), indicating a higher psychological permeability [ 89 ], consistent with the noted sensitivity and eccentricity of schizoid individuals within psychodynamic understandings.

FFM research generally finds openness to ideas and openness to aesthetics to be distinct factors. There is evidence for opposing influences between the two factors and positive psychotic symptoms, and correlational data indicates a relationship between the aesthetic/fantasy-prone dimension and schizophrenia spectrum disorders; therefore, a discussion of the psychological concept of aesthetics is relevant.

While a full interrogation of the science of aesthetics is beyond the scope of this paper, contemporary literature highlights some salient points about component experience. Firstly, that aesthetic appreciation derives neither from simple perception nor from straightforward complexity, but instead arises as a higher-order experience comprised of an evaluative dimension (sensory‐motor), a phenomenological/affective dimension (emotion‐valuation), and semantic (meaning‐knowledge) and their neural correlates [ 93 , 94 ]. Secondly, the appreciation arises from the diversity of sources of information that come into play, and the diversity of ways in which this information can be used, combined, and associated [ 95 ]. Thirdly, the aesthetic response can be reflexive and momentary, or manifest in long-lasting mood shifts [ 95 ]. Notably, this higher-order and emergent experience goes some way toward accounting for some of the difficulty in measuring motivational patterns in openness [ 36 , 96 ], which often seek to measure the value of merely novel information without context. As well, to the extent that schizotypal-spectrum experiences load onto openness and are dopaminergic, it dove-tails cleanly with dopamine models understanding the phenomenological function of the neurotransmitter as coding emotional salience [ 97 , 98 ]. As currently the dopamine hypothesis is one of the leading biological explanations for schizophrenia-spectrum disorders, this begins to offer a more intuitive understanding of such findings.

Comprehensively, this evidence indicates that the aesthetic dimension of openness implicated in schizotypal research is driven by an experience of derived or constructed meaning in complex stimuli. That is, recognizing and associating patterns (across sensory, affective, and cognitive levels) and deriving meaning. This is important as it begins to provide a phenomenological outline with potential neural mechanisms for many of the seemingly more inexplicable traits associated with the spectrum such as delusional thinking, disordered speech, and magical thinking in scientific research, as well as the noted predilection for symbolic and metaphorical understanding and high affective sensitivity in psychodynamic conceptualizations.

Contemporary approaches

Schizophrenia and related disorders occupy a unique place within the social consciousness. While contemporary discourse around mental health has demystified and destigmatized many disorders, experience of psychosis is rarely included in this trend. Even within the mental health field, individuals experiencing psychotic symptoms are differentially received. Clinicians across disciplines stigmatize patients with schizotypal spectrum syndromes more than patients with other diagnoses [ 99 , 100 , 101 ]. “Schizophrenia is one of the most serious and frightening of all mental illnesses. No other disorder arouses as much anxiety in the general public, the media, and doctors” [ 102 ], p. 91).

De-stigmatising psychosis as a symptom both separate from schizophrenia proper and “mad” in it’s own right is a hallmark of the Hearing Voices Movement (HVM), which began in the late 1980’s [ 18 , 103 ]. “Some disability scholars further emphasize the role of ‘madness as testimony’: as Clementine Morrigan explains, so-called symptoms occurring in the wake of trauma may in fact be ‘acts of resistance to violence,’ a means of sounding an alarm that something is very wrong” [ 18 ], p. 138).

More research is needed to establish an evidence-base for Hearing Voices Groups (HVGs); however, such psychosocial interventions hold promise, particularly since isolation is often a hallmark of both schizotypy and psychosis. Such group therapies approach treating the voices (auditory hallucinations) as non-pathological and not necessarily a sign that one is mentally ill. Participants in HVGs have reported a sense of higher self-esteem and social competence [ 104 , 105 ], while those who have learned to form more positive and active relationships with their voices have reported a less negative and sometimes supportive and beneficial relationship with said voices [ 106 , 107 , 108 ] Groups are growing, international, and are usually led by a “voice hearer” and a clinical practitioner. Though CBT interventions appear to be the most promising in terms of change mechanisms, more randomized clinical trials are needed [ 103 ]. Another psychosocial intervention that may hold promise is the concept of the Phone Pal (Into de Costa, 2020) to combat isolation in those experiencing psychosis. Marriage and family therapy is also effective for treating first-episode psychosis and reducing relapse rates [ 109 ].

Read and Dillon [ 3 ] utilized a grounded theory approach to collect qualitative data related to identifying effective psychosocial interventions. Researchers found that in cases of first-episode psychosis after which the patient desired to talk about and explore the experience, assisting the patient in such a discussion was therapeutic. Though it may be theoretically “simple,” perhaps it is in the process of relating to a caring and authentic other that one may find and share one’s own voice and begin to consolidate experiences. Such understanding embodies insight, which then results in a patient who “integrates” rather than “seals over” the psychotic experience. “Sealing over is the tendency to dismiss the experience as having little personal relevance, whereas ‘integration’ reflects a curiosity about the experience and its personal significance” [ 3 ], p. 180).

Within the Open Dialogue (OD) approach, patients within the population required the use of neuroleptics less frequently and for shorter periods [ 19 ]. While more an approach to care than a specific intervention, the hallmark of OD is shared decision- and meaning-making processes, aiming to guarantee both continuity of care and an immediate need-adapted and social network-oriented response. Research into interfamily therapy (which seeks to generate a conversation where experiences can be shared, and emotions can be expressed safely) has indicated lower relapse rates, with fewer psychiatric admissions and of shorter duration among patients during the year of participation [ 109 ], while a meta-analysis of 14 studies showed that family intervention in first psychotic episodes led to a 58% reduction in relapse rates, shorter duration of hospitalizations, less severe psychotic symptoms and improved functionality up to 24 months after the intervention [ 110 ].

In accounting for trauma within psychosis treatment, post-traumatic growth (PTG) was found to be elicited through narrative interaction with themes of meaning in life, coping self-efficacy and core beliefs; mediating the relationship between total PANSS scores and PTG. Notably, emotional experience was noted as the least frequent facilitator of PTG, casting doubt on the symptom -focused approaches of current treatment [ 111 ]. Consistent with this, individuals experiencing psychosis who engaged in poetry as a form of therapy and expression reported greater experiences of integration and acceptance, and overall higher senses of meaning and efficacy, through the practice. It was postulated that such carnivalesque spaces (in which the alternative, transgressive or idiosyncratic are explorable and celebrated) directly supported the wellbeing of the participants [ 112 ].

Taken in aggregate, the successes and implications of these approaches lends strong support to the overall premise of the proposed conceptualization. Namely, that the targeted eccentricities of schizotypal individuals are not themselves the issue within the population, but instead it is underlying stress and distress which drives the formation of states such as schizophrenia; and thus must themselves be the target of effective intervention. Moreover, that in reconnecting such individuals with others, providing a voice to meaningfully express their experiences, utilizing their sense of creativity and divergent thinking, and engaging their inner representational dynamic, the suffering experienced by schizotypal individuals can be mitigated without stigma or permanent pharmaceutical interventions.

“A good metaphor for psychotherapy of psychosis could be that it is a form of prayer: striving to bring order out of chaos, helping patients recover confidence in their humanness, seeking something of a resurrection, returning the patient to emotional life from a position of deadness” [ 3 ], p. 245).

Clinical implications

Taken as converging lines of evidence, the aforementioned paradigm allows for a reconceptualization of the psychopathology currently understood as schizophrenia and its related disorders as emergent properties of a particular spectrum of psychological predispositions under stress. Although a dimensional model, it does not adhere to any currently proposed but instead seeks to harmonize the evidence collected across multiple lines of inquiry. With this in mind, we propose a cybernetic model, which accounts not only for the strengths of dimensional templates but provides a means for elucidating the nature of development within and amongst those dimensions over time; offering means of understanding the emergent properties manifested in extreme poles or interactions. Models such as HiTOP are understood as arriving at their traits and dimensions from a predominantly “top-down” approach, working backwards from observed disorders to identify their constituent parts. Models such as FFM are oriented from a predominantly “bottom-up” perspective, and so can better capture what may be meant by normal personality. In so doing, it is proposed that informed clinicians would better understand how a person's natural interest in aesthetics might predispose them to proto-psychotic equilibrated states (thus aiding prognosis and early intervention) while also indicating how one might utilize this trait in strength-based treatment. As FFM already contains frameworks for understanding its dimensions as motivational frames, the component forces driving the homeostatic tendencies within the psyche (which give rise to the defense mechanisms and idiosyncratic feedback loops schizotypal syndromes would likely display) are explicable. While such a view certainly helps to normalize what might otherwise be seen as inexplicable psychosis, it also offers avenues for more robust and bespoke treatment and early identification of at-risk individuals.

At very early ages these individuals would likely have the heritable biological predispositions toward a specific general profile of FFM personality traits; namely some combination of high openness, low extraversion, high neuroticism, and low agreeableness. Probable attributes include high sensitivity to their external environment [ 55 , 113 ] and relatively socially reserved disposition [ 55 , 114 ]. Attachment theory research has shown how fundamental habits of behavior within mother-infant dyads create characteristic patterns that reinforce over time (Bowlby, as cited in [ 115 ]. Natural inclinations toward introversion and cognitive abstraction are likely to become reinforced by the overall social environment. Additionally, it is feasible that such individuals would be differentially rewarded for information-seeking, complex and conceptual pattern identification, and social interaction. As the individual developed his natural inclinations combined with idiosyncratic environmental patterns, disposition would tend toward the broad personality profiles described in psychodynamic literature, namely introverted, outwardly eccentric, metaphorically and fantasy-oriented, affectively and behaviorally sensitive, and favoring withdrawal when psychologically threatened. They would likely show heightened divergent thinking, be creatively or intellectually motivated, display less regard for social expectations, and show lower levels of trust in others overall.

Where the risk develops is in how these factors can interact under highly stressful and traumatic experiences. A natural tendency to withdraw rather than express leaves a person, particularly a developing child, far more vulnerable to further psychological damage [ 65 , 116 ]. Childhood trauma victims often develop magical or illogical narratives to conceptualize their experiences while maintaining identity integrity and basic trust. Children who do not externalize distress are far less likely to receive direct help or more mature interpretations from adults in their lives, and thus those beliefs are less likely to be revised. Introverted and eccentric children are predisposed to fewer and less frequent social interactions, yielding a slower growth curve in social competence, thus widening the gap and reinforcing natural tendencies to withdraw. Higher natural neuroticism creates a more sensitive threat-detection response, which coupled with natural distrust, high sensitivity to affect and behavior, divergent thinking, and high internal motivation toward complex pattern resolution, creates a network of feedback loops favoring loose, complex, affectively potent interpretive frameworks built on an internal lexicon to some degree tangential to consensus social understandings. As initially small and disparate behaviors and cognitive tools become habit, they begin to interact and create more complex syndromes based on the individuals’ natural tendencies, their specific environment, and their own phenomenological choices. The specific complexes will be in some ways unique; however, they will follow relatively predictable patterns. Based on the severity and specific combination of these, an individual is then ultimately given a categorical diagnosis of schizophrenia, schizoaffective, etc.

What is principal under this view is that while the traits underlying the more unique features of schizotypal psychosis are involved in the etiology of the disorder, none of them are themselves inherently pathological. Instead, they act as “paths of least resistance,” and in some cases, socio-behavioral risk factors when faced with highly stressful or traumatic experiences. In many ways, the symptoms of delusions, hallucinations, and disordered speech/behavior, etc., would then represent the individual’s greatest psychological strengths pushed well outside of their functional equilibrium and ultimately forced into self-reinforcing feedback loops. However, as it is trauma and emotional pain acting as fuel for these specific symptoms, it is here where treatment ought to focus. Certainly, the presence of psychotic symptoms would necessitate approaches specific to their management and interpretation; however, overall approaches would be formulated much more heavily along trauma recovery lines (i.e. establishing safety, building authentic relationships, reconnecting with the social environment, etc.). Indeed, it is likely that robust and prolonged treatment would need to engage constructively with the individual’s natural areas of strength as part of its process as they will represent that individual’s highest yield sources of positive affect, self-esteem, social recognition, etc. For example, to gain the benefits of greater social engagement, the schizotypal individual must be given the skills to utilize their naturally metaphorical style of communication effectively (rather than pushing them to conform to more traditional social expectations) for the interaction to feel authentic and the sense of connection to be meaningful.

Within a cybernetic model of the human psyche, the state of equilibrium is itself endlessly complex; inasmuch as it requires achieving physiological needs, fulfilling interpersonal needs, maintaining needs around identity and meaning, the solutions to which (in each case) impact one’s ability to do each of the others and more. This is further complicated by the fact that humans are dynamic and goal-oriented creatures, and so this state is itself a moving target constantly informed by experiences and shifting patterns of response. For conceptual purposes only, the specifics will be subsumed into the word equilibrium for now; however, by utilizing this lens, clear bridges can be made between the domains of clinical psychodynamics, personality theory, and biological research. What is frequently discussed under names of defense mechanisms, cognitive distortions, and behavioral patterns, etc., are understood as solutions and corrective measures to achieve this equilibrated state, the specifics of which are shaped by the natural inclinations of the individual (e.g. low extraversion) and their idiosyncratic experiences.

For example, an abused child may develop a narrative of nearly magical self-blame, as their ability to solve the problem of their suffering is nearly zero; however, they must find a logical explanation for their experiences to manage their anxiety, confusion, loss, and pain. Less extreme, a socially anxious person may simply stop engaging with people at all to keep anxiety tolerable. Each person’s specific needs will vary based on their makeup (this is roughly what is called “personality” in FFM), and thus there will be characteristic strategies, obstacles, and areas of flourishing individuals will construct along the way. However, as psyches are permeable structures by any measure, that natural equilibrium point can be moved over a lifetime. Each adaptation creates new forces of its own and must be accounted for by the others, thus necessitating new adaptations. A stressor of sufficient duration or intensity may demand such extreme adjustment that the settling point itself is (more or less) permanently moved. Within the dimensional models such as HiTOP, this is roughly the process by which dimensions impact each other and combine to ultimately create symptoms and syndromes.

In the case of schizotypy, we can highlight some tendencies. Naturally high levels of emotional salience beget heightened need for affect management; as they are likely also to score high in neuroticism, much of this heightened affect is likely to be anxiety-related. Tendencies toward introversion mean fewer opportunities to express internal states or experience other’s internal states. Differential motivation and reward systems create interest toward complex and abstract constructs (ideas, aesthetics, literature, etc.) and favors the individual toward inner worldbuilding over outer worldbuilding. During stressful experiences, natural tendencies to withdraw, to use imagination and abstract problem-solving skills, etc. are favored and likely to become habitual parts of identity. As is with any human trait or capacity, these bring their own sets of challenges and advantages; however, they are themselves neither pathological nor particularly unusual. Nonetheless, under extreme or prolonged stress, his natural tendencies can put the schizotypal person at heightened risk. Tendencies to withdraw mean that they are less likely to receive aid from others, and so prolonged isolated suffering is more likely. Heightened emotional salience means that the likelihood of an emotional overload is increased. Natural strengths in divergent thinking, coupled with tendencies toward abstraction, pattern recognition, and problem solving are likely to leave an individual anxiously searching their environment for explanations for and solutions to their unbearable feelings while receiving very little input from others.

Over time and based on the nature of the psyche-environment interaction, the entire structure of psychic equilibrium can begin moving in profound ways as the individual attempts to use the tools available and the conceptions to which they have experiential access, to navigate the world and manage their own phenomenology. Thus, natural abilities like divergent thinking, or tendencies such as withdrawal into fantasy, begin to themselves become overly stressed and utilized and may themselves become sources of stress as the person moves through life. However, while observing such a mind well into this process (e.g. unequivocal schizophrenia), though its entire makeup may appear fundamentally illogical, it is in fact a complex psychological adaptation to challenges and suffering in life. That is, constructs such as schizophrenia are unstable, heterogenous, and contentious because they are emergent properties within a complex and self-correcting system. While certainly accounting for etiology, heterogeneity, as well as currently clinically unaccounted for though empirically verified biopsychosocial factors, this frame also opens up approaches to treatment that account for differential motivational patterns (as established in FFM research), which indicate potentially effective strength-based modalities for the population.

The various models, perspectives, and orientations discussed so far represent a wide cross-section of interest into the phenomenon of psychosis and schizophrenia spectrum disorders, as well as personality and psychological research. It is the stance of this paper that these and others represent converging lines of evidence for a schizotypal population naturally occurring within the larger human population overall. Furthermore, this population would span the range from “normal” and “high-functioning” individuals to those experiencing major and prolonged schizophrenic episodes. This schizotypal population would thus be best conceptualized as a cohort “at-risk” of schizotypal psychosis; depending on the number of relevant traits held, their overall intensity, their interactions with each other, and interactions with the environment. The disorders referred to as schizophrenia, schizoaffective, STPD, etc., represent relatively stable emergent states of consciousness appearing as a result of stressful and traumatic experiences within an otherwise healthy population. While their specific presentations may be particularly disorienting and extreme within foundational rationalistic frameworks, they are, in fact, extensions of natural human adaptations under prolonged and/or extreme duress.

Under the proposed conceptualization, a dimensional model similar to HiTOP views the higher-order symptoms accounted for in the DSM as phenomena emergent from specific combinations of more general and mutually influencing sub-traits and behaviors. Rooted in FFM research, this model can be extended beyond simple decomposition of maladaptive traits and defense mechanisms and thus understand how such extreme outcomes arise out of “normal” human personality features while accounting for heritable and biological substrate noted throughout the literature. Functionally, the model reconceptualizes the biological and phenomenological development of more extreme schizotypal presentations as a cybernetic system, in which the ongoing interactions of multiple elements attempting equilibrium to experiences of trauma and stress (whether acute, periodic, or ongoing) arrive at explicable resting states. Thus, disorders such as schizophrenia can be understood as emergent properties of more fundamental systemic interactions rather than discrete disorders in and of themselves. Such a model would account for the clinically significant distinction between those experiencing psychotic episodes and those diagnosed with a schizophrenia-spectrum disorder, as well as the apparent contradiction between the heterogeneity of presentation and the phenotypic resemblance of said disorders.

To the extent that the above is true, this allows not only for a more accurate and tailored understanding of etiology, but also suggests means of risk factor detection early in life and a theoretically sound strengths-based approach to treatment accounting for the underlying affective and characterological engines behind currently targeted symptoms. In so doing, the heterogeneity of traditionally taxonomic disorders is accounted for while offering conceptual bridges between biological, cognitive-behavioral, and psychodynamic understandings of the population and outlining explanatory frameworks for differences between brief psychotic episodes, ongoing and degenerative schizotypal-spectrum disorders, and those cases of total or periodic remission attested to in more culturally diverse literature.

It is the hope of the authors that the proposed understanding of schizotypy as a spectrum rooted in natural and even beneficial psychological functions, and with explicable trauma-driven manifestations, will assist not only in furthering the field’s knowledge of human functioning and treatment of psychosis, but also begin to remove the stigma and aversion which have grown around the concepts. Grounded assessments for early detection will offer incremental validity to a genuinely biopsychosocial approach to research, treatment, and ongoing patient management.

Availability of data and materials

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JL was responsible for the original ideas of the paper, the new conceptual model, and the identification and elucidation of the philosophical and historical precedents. RH contributed to each of JL’s ideas by adding more explanation or attempting to clarify concepts to readers. RH performed most of the editing of the paper. All authors read and approved the final manuscript.

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Long, J., Hull, R. Conceptualizing a less paranoid schizophrenia. Philos Ethics Humanit Med 18 , 14 (2023). https://doi.org/10.1186/s13010-023-00142-8

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Cognitive behavioral therapy for schizophrenia: an empirical review

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• 1 Centre for Addiction and Mental Health, Clarke Institute of Psychiatry and Department of Psychiatry, University of Toronto, Ontario, Canada.
• PMID: 11379970
• DOI: 10.1097/00005053-200105000-00002

Early case studies and noncontrolled trial studies focusing on the treatment of delusions and hallucinations have laid the foundation for more recent developments in comprehensive cognitive behavioral therapy (CBT) interventions for schizophrenia. Seven randomized, controlled trial studies testing the efficacy of CBT for schizophrenia were identified by electronic search (MEDLINE and PsychInfo) and by personal correspondence. After a review of these studies, effect size (ES) estimates were computed to determine the statistical magnitude of clinical change in CBT and control treatment conditions. CBT has been shown to produce large clinical effects on measures of positive and negative symptoms of schizophrenia. Patients receiving routine care and adjunctive CBT have experienced additional benefits above and beyond the gains achieved with routine care and adjunctive supportive therapy. These results reveal promise for the role of CBT in the treatment of schizophrenia although additional research is required to test its efficacy, long-term durability, and impact on relapse rates and quality of life. Clinical refinements are needed also to help those who show only minimal benefit with the intervention.

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Positive symptoms of schizophrenia and their relationship with cognitive and emotional executive functions

• Pamela Ruiz-Castañeda 1 , 2 ,
• Encarnación Santiago Molina 3 ,
• Haney Aguirre Loaiza 4 &
• María Teresa Daza González   ORCID: orcid.org/0000-0002-6561-8982 1 , 2  

Cognitive Research: Principles and Implications volume  7 , Article number:  78 ( 2022 ) Cite this article

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Positive symptoms of schizophrenia are associated with significant difficulties in daily functioning, and these difficulties have been associated with impaired executive functions (EEFF). However, specific cognitive and socio-emotional executive deficits have not been fully established.

The present study has several objectives. First, we aimed to examine the specific deficits in cognitive and socio-emotional EEFF in a group of patients with schizophrenia with a predominance of positive symptoms, as well as to determine if these patients present clinically significant scores in any of the three fronto-subcortical behavioral syndromes: Dorsolateral, Orbitofrontal, or Anterior Cingulate.

The sample consisted of 54 patients, 27 with a predominance of positive symptoms, and 27 healthy controls matched for gender, age, and education. The two groups completed four cognitive and three socio-emotional EEFF tasks. In the group of patients, positive symptoms were evaluated using the scale for the Evaluation of Positive Symptoms (SANS), while the behavioral alterations associated with the three fronto-subcortical syndromes were evaluated using the Frontal System Behavior Scale (FrSBe).

The patients, in comparison with a control group, presented specific deficits in cognitive and socio-emotional EEFF. In addition, a high percentage of patients presented clinically significant scores on the three fronto-subcortical syndromes.

The affectation that these patients present, in terms of both cognitive and emotional components, highlights the importance of developing a neuropsychological EEFF intervention that promotes the recovery of the affected cognitive capacities and improves the social and emotional functioning of the affected patients.

Introduction

The study of the positive symptoms (PS) of schizophrenia (such as prominent delusions, hallucinations, formal thought disorder, and bizarre behavior) is of particular interest both because of the severity of these symptoms and their consequences for the daily functioning of the patient and their impact on their caregivers. This psychotic clinic is usually associated with more significant social stigma and a higher rate of relapses and hospitalizations (Green, 1996 ; Holmén et al., 2012 ).

From a neuropsychological point of view, current research has realized that the study of neurocognition has important implications for understanding the prognosis, treatment, and neural systems of schizophrenia (Green et al., 2019 ; Molina & Tsuang, 2020 ; Seidman & Mirsky, 2017 ). Various investigations have suggested that the most pronounced neurocognitive deficits in these patients could occur in executive functions (EEFF) (Addington & Addington, 2000 ; Díaz-Caneja et al., 2019 ; Fonseca-Pedrero et al., 2013 ; Mingrone et al., 2013 ; Nieuwenstein et al., 2001 ). These functions are directly related to the quality of life and are considered significant predictors of the patient's prognosis (Bobes García & Saiz Ruiz, 2013 ). Several studies have highlighted these deficits as a strong predictor for the development of psychiatric disorders (Ancín et al., 2013 ; Sawada et al., 2017 ). Thus, the study carried out by Bolt et al. ( 2019 ) in patients with “ultra-high risk” of suffering from psychosis found that the EEFF were the only neurocognitive domain that emerged as a significant predictor of the transition to threshold psychosis full. The patients who had more pronounced deficits in this domain were those who developed psychosis in a mean period of 3.4 years. Similarly, Eslami et al. ( 2011 ) found that EEFF deficits at baseline were significant predictors of social functioning and occupational decline within one year. Therefore, these types of results could indicate that FFEE deficits may be a highly sensitive indicator of disease transition risk and poor functional outcomes.

Furthermore, in the scientific literature, a distinction has been established between the more cognitive aspects of EEFF, also called “ cool ” components, and the more socio-emotional, or “ hot ” components (Peterson & Welsh, 2014 ; Prencipe et al., 2011 ; Welsh & Peterson, 2014 ).

Cool EEFF include those cognitive processes manifested in analytical and non-emotional situations, primarily associated with the dorsolateral regions of the prefrontal cortex (Henri-Bhargava et al., 2018; Kamigaki, 2019). Within these EEFF, we would find at least three central components: (1) the processes of coding/maintenance and updating of information in working memory (WM); (2) inhibitory control; and (3) cognitive flexibility (Miyake & Friedman, 2013 ; Miyake et al., 2000 ). In addition, other more complex functions such as planning, abstract reasoning, or problem-solving are developed from these central components. In contrast, hot EEFF include those processes involved in contexts that require emotion, motivation, and tension between immediate gratification and long-term rewards (Zelazo & Carlson, 2012 ; Zelazo & Mller, 2007 ). Are mediated by the ventromedial and orbitofrontal cortices that support behaviors that require emotional regulation, decision-making in situations of uncertainty, recognition of facial expressions and their emotional content, as well as in the ability to infer the perspective of others, also known as mentalization or theory of mind (ToM) (Welsh & Peterson, 2014 ; Zimmerman et al., 2016).

Regarding decision-making in situations of uncertainty, it is a complex process that could be defined as the choice of an option among a set of alternatives, considering the possible results of the choices and their consequences on behavior (Kim & Lee, 2012 ; Xiao et al., 2012). Within this framework, Damasio ( 1994 ) postulates his “Somatic Marker” hypothesis to explain the role of emotions in reasoning and decision-making. In this sense, a Somatic Marker is an automatic emotional response that it is produced by the perception of a certain situation, and which in turn evokes past experiences. Specifically, the neural system for the acquisition of Somatic Marker signals is found in the orbitofrontal and ventromedial portion of the prefrontal cortex. Regarding the theory of the mind, authors such as Zimmerman et al. (2016) describe it as an emotional function that refers to the processes responsible for the perception and identification of emotions, such as empathizing with the affective state of another person. Specifically, the neuroanatomical network associated with ToM includes the medial prefrontal region of the prefrontal cortex, the posterior cingulate cortex, the amygdala, the temporoparietal junction, and the temporal sulcus, bilateral superior–posterior (Amodio & Frith, 2006 ; Ilzarbe et al., 2021 ; Zemánková et al., 2018 ).

Regarding the alterations in cool EEFF presented by patients with a predominance of PS, the results reported to date are inconclusive. On the one hand, studies that have analyzed EEFF through classical paper-and-pencil neuropsychological tests (e.g., Wisconsin Card Sorting Test; Trail Making Test A and B) have reported poor performance in these patients, suggesting general executive impairment (Addington et al., 1991 ; Zakzanis, 1998 ). Moreover, correlations have been reported between PS such as formal thought disorders and persistently bizarre behavior with cool executive components, such as inhibition and cognitive flexibility, pointing to a marked deficit in inhibitory control (Brazo et al., 2002 ; Laplante et al., 1992 ; Li et al., 2017 ; Subramaniam et al., 2008 ). On the other hand, other symptoms such as delusions and hallucinations have been moderately related to difficulties in processing speed, cognitive flexibility, and information updating processes in WM (Ibanez-Casas et al., 2013 ; Laloyaux et al., 2018 ). It has even been proposed that the PS are possible consequences of the deficits in self-monitoring capacity that are shown by these patients (Spironelli & Angrilli, 2015 ).

However, and in contrast to these investigations, other studies suggest conservation of EEFF in these patients (Berenbaum et al., 2008 ; Clark et al., 2010 ) or at least a minimal relationship with PS. Thus, some studies report low or null correlations between symptoms such as delusions or hallucinations and performance on verbal fluency, WM, and attention tasks (Berenbaum et al., 2008 ). Similarly, null correlations have been observed between delusions and hallucinations and performance on tasks that assess resolution problems, working memory, verbal and visual memory, and processing speed, and, using these same tasks, low or moderate correlations with symptoms such as formal thought disorders or bizarre behavior (Ventura et al., 2010 ).

An important question is whether these results could be influenced by the clinical or socio-demographic variables of the sample. In this regard, some studies (Addington et al., 1991 ; Zakzanis, 1998 ) have concluded that performance on EEFF tests is not related to the age of the participants, the number of admissions, the age of disease onset, or type of medication (chlorpromazine equivalents).

The literature on socio-emotional or hot EEFF has also yielded mixed results. Regarding decision-making in situations of uncertainty (participants do not have direct information about the disadvantages of their choices and do not have the opportunity to establish a reasonable strategy at the beginning of the task (Pedersen et al., 2017 )), the studies that have examined the performance of patients with a predominance of PS in the Iowa Gambling Task (IGT) show inconsistent results. Some studies have found negative correlations between symptoms such as hallucinations and prominent delusions and performance on this task compared to controls. In particular, a higher PS score was correlated with a lower Net Score (number of disadvantageous options minus the number of advantageous options), fewer advantageous choices (Struglia et al., 2011 ), and a greater number of disadvantageous choices (Pedersen et al., 2017 ). Other studies, however, using the same paradigm (IGT), did not find differences in performance compared to controls or correlations between IGT performance and symptomatology (Evans et al., 2005 ; Ritter et al., 2004 ; Wilder et al., 1998 ).

Regarding the ability to infer mental states or theory of mind, a generalized deterioration has been reported in these patients, particularly in those with marked PS such as delusions and hallucinations (Corcoran et al., 1995 ). However, in contrast, it has been hypothesized that for the development of certain PS such as persecutory delusions, an intact theory of mind is required, since this is necessary for inferring the intentions of others, even though these inferences are not correct (Peyroux et al., 2019 ; Walston et al., 2000 ).

When analyzing the possible influence of clinical and demographic variables on the results of these studies, although the studies have not considered this as a primary objective, the patients were matched with the control group in terms of age, gender, or education, which has led the authors to suggest that these variables are not the cause of the results and that patients perform the task in a different way to controls (Corcoran et al., 1995 ; Peyroux et al., 2019 ).

On the other hand, from a neuropsychological point of view, it has been suggested that the heterogeneity and diversity of symptoms shown by patients with schizophrenia could be a consequence of a malfunction of brain circuits of fronto-subcortical origin (Fornito et al., 2012 ; Penadés & Gastó, 2010 ). According to this approach, schizophrenia tends to be considered as a neuronal connectivity disorder and its different symptomatology could be explained by using the distributed neural network model (Goldman-Rakic, 1994 ; Pantelis & Brewer, 1995 ; Wang et al., 2014 ). This model posits that control of any cognitive function is distributed across several interconnected nuclei throughout the brain. The interruption of any of these nuclei or their interconnections would produce changes in cognitive function (Baars & Cage, 2010 ). In this sense, the involvement of these prefrontal areas and/or their connections with other subcortical regions (e.g., the fronto-subcortical circuits of prefrontal origin: Dorsolateral syndrome, related to executive deficits; Orbitofrontal syndrome, related to disinhibition; and syndrome Anterior Cingulate, related to apathetic behaviors (Bonelli & Cummings, 2007 ; Tekin & Cummings, 2002 )), could result in specific deficits in the different cool and hot components of the EEFF (Slachevsky Ch. et al., 2005 ).

In this sense, and regarding the brain areas involved in the PS of schizophrenia, these are not yet fully established. Some inferences in this regard have been obtained from patients with traumatic brain injury (TBI) who have developed clinical symptoms and behaviors like those presented in patients with PS in schizophrenia after the injury. Psychotic symptoms such as hallucinations, persecutory delusions, and thought disorders (loosening of associations, tangentiality, or thought blockage) occur more frequently in patients with TBI than in the general population (Fujii & Ahmed, 2002 ; Sachdev et al., 2001 ).

Similarly, a high percentage of patients with TBI also show significant alterations upon neuropsychological examination, similar to those presented by patients with psychotic symptoms, particularly in executive functions and memory (Berrios, 2013 ). These alterations have been associated with post-traumatic structural lesions located in different brain regions, such as the frontal cortex (dorsolateral and orbitofrontal), and, in those structures that form the so-called fronto-subcortical circuits (Alexander et al., 1986 ; Pettersson-Yeo et al., 2011 ).

Therefore, and in summary of the above, two main conclusions can be drawn. First, a review of the current literature has revealed inconclusive results regarding the level of alteration in cool and hot EEFF presented by schizophrenic patients with a predominance of PS. Moreover, there is no conclusive relationship between specific executive components and PS.

Second, the findings of neuroanatomical studies on the affectation of the fronto-subcortical circuits in TBI patients who develop behaviors and PS similar to those presented by patients with schizophrenia could suggest possible alterations of these circuits in schizophrenic patients. Therefore, it is possible that patients with schizophrenia with a predominance of PS present behaviors associated with the so-called fronto-subcortical syndromes (Dorsolateral Prefrontal Syndrome, related to executive deficits; Orbitofrontal syndrome, related to disinhibition; and Anterior or Mesial Cingulate Syndrome, related to apathic behaviors). However, to our knowledge, there is no previous study that has explored the possible involvement of the fronto-subcortical circuits in patients with positive symptoms from the presence of behaviors associated with fronto-subcortical syndromes.

Thus, the present study had several objectives. First, we aimed to study the specific deficits in cool and hot EEFFEF in a group of patients with schizophrenia with a predominance of PS, in comparison with a control group of healthy participants matched for age, gender, and educational level. Second, we set out to study the influence of the main clinical variables (years of evolution of the disease, clinical treatment device, and pharmacological treatment) on executive task performance shown by these patients. Third, we aimed to explore the possible relationship between the severity of PS (hallucinations, delusions, bizarre behavior, and formal thought disorders) with performance on both cool and hot EEFF tasks. And, finally, we wanted to confirm if these patients present clinically significant scores on any of the three fronto-subcortical behavioral syndromes: Dorsolateral, Orbitofrontal, or Anterior Cingulate. (These were measured through the self-reported version of the Frontal System Behavior Scale—FrSBe.)

Considering the previous literature concerning our first objective, we expect psychotic patients with a predominance of PS to show significantly poorer performance on the EEFFEF tasks in comparison with healthy controls. Moreover, in terms of clinical variables, we expect that the years of disease duration, the clinical treatment device, and the type of pharmacological treatment could affect the performance of patients on EEFF tasks.

Regarding the third objective, we expect that the patients with the highest scores on the scale for the Evaluation of Positive Symptoms (SAPS) also show poorer performance on the EEFFEF tasks. Regarding the fourth objective, we anticipate that these patients with a predominance of PS will present some of the frontal behavioral syndromes.

Materials and methods

Participants.

The initial sample consisted of 128 participants (age range: min = 20, max = 61, M age  = 37.4, SD  = 10.7). The selection process is shown in Fig.  1 . The final sample consisted of n  = 54 participants (age range: min = 20, max = 60), of both genders: men ( n  = 49, 74.2%, M age  = 43.6, SD  = 11.0), women ( n  = 17, 25.8%, M age  = 44.2, SD  = 11.0); 27 patients with schizophrenia, and 27 participants assigned to the control group.

Flow of participants throughout the study

Criteria for inclusion and exclusion of the experimental group

Inclusion criteria.

Patients between 18 and 57 years.

Defined diagnosis of schizophrenia

Minimum of two years of evolution of the disease

PS predominance. For this, those patients who showed a higher percentage score in the Evaluation of Positive Symptoms (SAPS) than in the Scale for the Evaluation of Negative Symptoms (SANS) were selected.

Likewise, the psychopathological stability and motivation of the patient were considered, selecting psychopathologically stable patients to carry out the evaluation. The referral psychiatrist established this criterion based on prior knowledge of the patient's clinical status, ensuring sufficient compensation and motivation for participation in the study.

Exclusion criteria

Participants whose main diagnosis is an organic mental disorder, a different medical or psychological illness.

Electroconvulsive treatment in the last 2 years,

Patients with very low motivation for active participation in the study.

Criteria for inclusion and exclusion of the control group

Subjects between 18 and 57 years

Subjects who could be matched with the patients in age, gender, and educational level.

Have no history of mental, neurological, or substance abuse illness,

Not be medicated with any psychotropic medication.

Those participants who did not meet the inclusion criteria were excluded.

The patients were selected from the various medical facilities of the Mental Health unit of the reference Hospital Complex of the city. Regarding the socio-demographic variables, three levels were established according to the years of schooling: basic (6 years), medium (between 7 and 12 years), and high (more than 12 years). Regarding the clinical variables, for the duration of the illness, two levels were established according to the sample mean: a group with a shorter duration off illness (less than 11 years) and another group with a longer duration of illness (more than 11 years). Regarding clinical treatment service, two levels were established according to whether they received treatment in an inpatient or outpatient setting. For pharmacological treatment, two levels were established according to whether they took typical or/and atypical medications, and other medications unrelated to mental illness. The control group was matched with the patients in terms of age, gender, and years of schooling. The selected participants had no history of mental, neurological, or substance abuse illness and were not taking any psychotropic medications. The study was carried out in accordance with the guidelines of the Declaration of Helsinki and was approved by the Research Ethics Committee of Centro-Almería belonging to the Torrecárdenas Hospital Complex in the city of Almería (protocol code 52,780. approval date: 26 / 10/2014). The patients/participants provided their written informed consent to participate in this study.

Execution tasks

For the study of cool EEFF, four different neuropsychological tasks were used: 1) the Sternberg-type task, which assesses the processes of encoding/maintaining information in working memory (WM); 2) the 2-back task, which evaluates the monitoring and updating processes of information in WM; 3) the Number–Letter task, which assesses cognitive flexibility or ability to change or alternate the mental set; and 4) a computerized version of the Tower of Hanoi (THO), which evaluates the planning processes involved in the preparation of ordered sequences of actions to achieve specific objectives.

Regarding the hot EEFF, the following three tasks were used: 1) a computerized version of the Iowa Gambling Task (IGT) which assesses decision-making processes in situations of uncertainty; 2) a computerized task for the recognition of facial emotional expressions, and 3) a pencil and paper version of the Hinting task that evaluates the theory of mind (ToM) (See Table 1 ). For a more detailed description of the cool and hot EEFF tasks used in the present study, see Ruiz-Castañeda et al. (Ruiz-Castañeda et al., 2020 ).

Scales for the evaluation of psychotic symptoms and frontal behavioral syndromes

To evaluate positive and negative symptoms, the Scale for the Evaluation of Positive Symptoms (SAPS) (Andreasen, 1984 ) and the Scale for the Evaluation of Negative Symptoms (SANS) (Beck & Chaudhari, 1976 ) were used. The behavioral alterations associated with the three frontal syndromes: Dorsolateral Syndrome (executive dysfunction); Orbitofrontal Syndrome (disinhibition); and Anterior or Mesial Cingulate Syndrome (apathy), were evaluated using the Spanish version of the Frontal System Behavior Scale (FrSBe) (Grace & Malloy, 2001 ; Pedrero-Pérez et al., 2009 ) .

For all participants (experimental and controls), the EEFF tasks were administered by two researchers so that one of them always carried out the evaluation, while the second investigator supervised these evaluations. For the patients, the evaluation took place across two individual sessions of approximately 50 min, each with the necessary breaks required by the participant. In the case of the control group, most of them required a single session of approximately 60 min, with the necessary breaks. The evaluation sessions were carried out individually in a quiet room using a laptop.

In the case of patients, the SANS and SAPS scales were administered by the referral physicians (psychiatrists or clinical psychologists). The self-reported version of the FrSBe Scale could be completed by the patient independently (in the researcher's presence) or by the researcher, always trying to ensure the maximum understanding of the questions.

To select psychotic patients with a predominance of PS, the following procedure was applied. Once the patients' referral psychiatrists or clinical psychologists completed the SAPS and SANS scales for each patient, the total scores for each scale were calculated. Each score was then transformed into a percentage. For the SAPS scale, the percentage is calculated based on the maximum score obtained on this scale (170), following the same procedure for the SANS scale (maximum score = 150). Finally, those patients who had a higher percentage on the SAPS scale ( M  = 24.0, DT  = 16,3) than on the SANS ( M  = 15.1, SD  = 14.4) were selected.

Statistical analysis

The data were processed through a descriptive and frequency analysis to characterize the socio-demographic and clinical variables. In the exploratory analysis of the data of the response variables, missing data were found, which were imputed to the median value of each group. Outliers were maintained to ensure consistency with the performance of the evaluated. Gender was matched in each group (n = 17 male, n = 10 female). Age was compared with the Mann–Whitney U test, and education level was assessed with X . 2

The direct scores of the neuropsychological tasks were transformed into Z scores. Two multivariate analysis models (MANOVA) were carried out, one with all the measures of the cool EEFF tasks and the other with the measures of the hot EEFF tasks. The first model was EEFF- cool * groups (9 × 2), and the second model was EEFF- hot * groups (6 × 2). Assumptions of normality for hypothesis testing were checked through standardized residuals in both groups. The assumption of equality of covariances was estimated with Box's test, and the multivariate Lambda test of Wilks (Λ) was used. The analysis of multiple comparisons between patients and controls was corrected with Sidak’s procedure. For the comparisons that showed significant differences, the confidence interval (95% CI) of the differences was reported. The effect size was estimated with eta squared ( η p 2 ), using the following values: < 0.01 small, 0.06 moderate, and > 0.14 strong (Cohen, 1988 ).

Pearson's r correlation analyses were conducted between PS and EEFF tasks. To check whether the patients with PS had clinically significant scores in any of the three frontal behavioral syndromes, the direct scores obtained on the FrSBe scale were converted into standardized scores ( T ) according to the age, education, and gender of the participant. With these T scores, three ranges of affectation can be obtained according to their cutoff point: no risk (< 59 points); high risk or borderline (60 to 64); and clinically significant (> 65). The data analyses were conducted using SPSS v.23.0. Post hoc statistical power ( 1-β ) was calculated with G * Power software (Faul et al., 2009 ).

No significant differences were found between patients and controls in age [U( N patients  = 33, N controls ) = 542.0, z  = − 0.03, p  = 0.974], gender [ X 2 (1)  = 0.79 , p  = 0.778], or years of education [ X 2 (2)  = 0.83 , p  = 0.959]. The socio-demographic and clinical characteristics are shown in Table 2 .

Cool EEFF tasks

The descriptive data of the cool EEFF comparing patients with controls are shown in Table 3 . The MANOVA analysis revealed a significant interaction between the cool EEFF and the groups [ Wilks’ Λ  = 0.498, F (9, 44) = 4.93, p  < 0.001, ηp 2  =  0.50, 1-β  =  0.99 ]. Better performance on the cool EEFF tasks was observed in the control group.

A main effect was found in the two conditions of the information coding/maintenance task in WM (Sternberg-type task) [low load: F (1, 52) = 4.86, p  = 0.032, ηp 2  =  0.08, 1-β  =  0.58 ; and high load: F (1, 52) = 8.19, p  = 0.006, ηp 2  =  0.136, 1-β  =  0.8 0]. Likewise, a main effect was found for the task of updating the information in WM (2-Back task) [ F (1, 52) = 16.69, p  < 0.001, ηp 2  =  0.243, 1-β  =  0.9 8].

Regarding performance on the task that assesses cognitive flexibility (Number–Letter task), only significant “task-switching costs” (TSC) were observed with reaction time (TSC TR ) [ F (1, 52) = 5.38, p  = 0.024, ηp 2  =  0.094, 1-β  =  0.6 24]. Regarding the planning task (Tower of Hanoi), only one main effect was observed with the latency measure in the short planning condition [ F (1, 52) = 5.27, p  = 0.026, ηp 2  =  0.092, 1-β  =  0.6 15] (See Fig.  2 ).

Cool EEFF compared between patients and controls. Note : TSC = Task-switching costs. RT = Response time. * p  < 0.05. ** p  < 0.01. *** p  < 0.001

Hot EEFF tasks

The descriptive data of the hot EEFF comparing patients and controls are shown in Table 4 . The MANOVA analysis revealed a significant interaction between the hot EEFF tasks and the groups [ Wilks’ Λ  = 0.475, F (6, 47) = 8.642, p  < 0.001, ηp 2  =  0.52, 1-β  =  1.0 ]. Better performance on the hot EF tasks was observed in the control group.

Regarding the task that assesses decision-making under conditions of uncertainty (Iowa Gambling Task), the analysis of the Net Score measure (Nº of Advantageous choices—Total Nº of disadvantageous choices) did not show a significant effect [ F (1, 52) = 0.19, p  = 0.657, ηp 2  =  0.004, 1-β  =  0.07 ].

In contrast, the task that measures the recognition of facial emotional expressions showed significant effects on errors, both in basic facial expressions [ F (1, 52) = 5.993, p  = 0.018, ηp 2  =  0.10, 1-β  =  0.67 ], as in complex facial expressions [ F (1, 52) = 9.34, p  = 0.004, ηp 2  =  0.15, 1-β  =  0.85 ]. Similarly, significant effects were also observed in reaction times, both for the condition of basic facial expressions [ F (1, 52) = 21.20, p  < 0.001, ηp 2  =  0.29, 1-β  =  0.99 ], as complex [ F (1, 52) = 16.34, p  < 0.001, ηp 2  =  0.23, 1-β  =  0.98 ]. Finally, the performance of the task that assesses the theory of mind (Hinting Task) was significant [ F (1, 52) = 29.06, p  < 0.001, ηp 2  =  0.35, 1-β  =  1.0 ] (See Fig.  3 ).

Hot EEFF compared between patients and controls. Note : IGT = Iowa Gambling Task. FEE =  Facial emotional expressions. RT = Response time. * p  < 0.05. ** p  < 0.01. *** p  < 0.001

Clinical variables and patient performance in hot and cool EEFF tasks

Regarding the variable years of disease evolution , differences were only observed in the errors of the planning task (Tower of Hanoi) in the condition of precision in short planning [ t (31) =  − 2.51, p  = 0.034, d  = 0.71 95%CI (− 1.86, − 0.08)]; that is, patients with a short disease evolution (less than 11 years) showed better performance [ n  = 15; M  = − 0.25, SD  = 0.62], than the patients with long disease evolution (more than 11 years) [ n  = 12; M  = 0.71, SD  = 1.3]. Based on these results, we wanted to analyze whether the short evolution group showed similar performance to the control group [ n  = 27; M  = − 0.17, SD  = 0.88] and found that these two groups did not differ.

Regarding the clinical device in which the patients received the intervention, no significant differences were found in performance between patients with an outpatient intervention (n = 17) and patients with in-hospital intervention (n = 10).

Regarding pharmacological treatment , no significant differences were found between the group of patients taking typical and/or atypical antipsychotics (n = 23) and those receiving other medication unrelated to mental illness (n = 4). Given these results, we wanted to check whether there were significant differences between those patients who were taking typical medications or a combination of typical and atypical ( n  = 4), and those who were only taking atypical medications or other non-psychotropic medications ( n  = 23), finding no significant differences between these two groups.

Correlations between positive symptoms and performance on the cool and hot EEFF tasks

The results of the correlation analysis between the severity of the PS and performance on the cool and hot EEFF tasks are shown in Table 5 . Regarding the cool EEFF tasks, both the hallucination symptoms ( r  = − 0.47, p  = 0.012) and delusions ( r  = − 0.39, p  = 0.044) were related to the planning task (the Tower of Hanoi), in the latency condition in short planning.

Regarding the symptoms of bizarre behavior , these correlated with the task of coding/maintaining the information in WM (Sternberg-type task) in the low load condition ( r  = 0.42, p  = 0.027). Formal thought disorder symptoms correlated with the cognitive flexibility task (Number–Letter task) in the TSC TR condition ( r  = 0.44, p  = 0.022), as well as the reaction times in the long planning condition ( r  = 0.38, p  = 0.047).

Regarding the hot EEFF, the symptoms of formal thought disorder correlated with performance on the theory of mind task (Hinting Task) ( r  = − 0.46, p  = 0.016).

Frontal Behavioral syndromes in patients with positive symptoms

Regarding the presence of the three frontal behavioral syndromes in patients with PS, we found that for Dorsolateral syndrome (executive dysfunction subscale), 81.5% presented a clinically significant score. For Orbitofrontal syndrome (Disinhibition subscale), 59.3% had a clinically significant score, while 77.8% had a clinically significant score for the anterior cingulate syndrome (Apathy subscale).

The objectives of this work were to (1) study the specific deficits in the cool and hot EEFF in a group of patients with schizophrenia with a predominance of PS, compared to a control group of healthy subjects matched for age, gender, and educational level; (2) study the influence of the main clinical variables (years of evolution of the disease, pharmacological treatment, and clinical service through which treatment is received) on the performance of patients on EEFF tasks; (3) explore the possible relationship between the severity of PS and the performance of patients on EEFF tasks; and finally (4) verify if the patients present clinically significant scores for any of the three frontal behavioral syndromes (Dorsolateral, Orbitofrontal, and Anterior Cingulate).

Alterations in cool EEFF

As we expected, the patient group showed significantly poorer performance than the control group on the cool EEFF tasks.

Regarding working memory , our data agree with findings in the previous literature (Forbes et al., 2009 ; Menon et al., 2001 ). In our study, patients showed poor performance on the two components of WM that we evaluated: coding/maintenance of information (Sternberg-type task) and updating of information in WM (2-Back task). Accordingly, various studies have highlighted the importance of WM in PS, such as hallucinations, formal thought disorders, or delusions (Díaz-Caneja et al., 2019 ).

Regarding hallucinations, a relationship has been observed between auditory hallucinations and deficits in verbal WM tasks (Bruder et al., 2011 ). Given these findings, it has been argued that WM deficits could predict the presence of auditory verbal hallucinations(Jenkins et al., 2018 ); even from a first psychotic episode (Gisselgård et al., 2014 ), or in the general population who have more frequently experienced psychotic experiences (hallucinations and delusions) but who have not been diagnosed with mental illness (Rossi et al., 2016 ). In this sense, it has been observed (in a group of adolescents with reports of psychotic experiences in the absence of clinical disorder) that increasing the WM load when moving from a 2-back task to an overload in the 3-back task was associated more strongly with a higher level of psychotic experiences. Similarly, and through signal detection theory (SDT), an increase in false alarms was found to be associated with stronger psychotic experiences, as well as greater false recognition of auditory signals and words (Rankin & O’Carroll, 1995 ), suggesting that decreased discrimination is a characteristic of positive psychotic phenomena (Bentall & Slade, 1985 ; Rossi et al., 2016 ).

Deficits in WM have also been implicated in formal positive thinking disorders. According to authors such as Goldman-Rakic (Goldman-Rakic, 1994 ), the derailment, the loss of logical associations in thought, the inability to perceive causal relationships, or typical behavior through internal mental representations are the product of weaknesses in WM. Similarly, symptoms such as tangentiality, poor planning, cohesion of discourse, and deficiencies in information processing have specifically been linked to a dysfunction in updating and retrieving information from verbal WM (McGrath et al., 1997 ).

Regarding the performance on the task that assesses the capacity for cognitive flexibility (Number–Letter task), our patients only showed higher task-switching costs in reaction times (TSC TR ) compared to controls, but not a higher cost of switching in terms of errors committed (TSC Error ) (categorizing a stimulus as consonant or vowel, according to the position of the squares in which it appears, compared to the performance when they do not have to make such a change).

In patients with PS, although some studies have found that a poorer ability to change the mental set allowed for distinguishing patients who presented auditory verbal hallucinations from those who did not (Siddi et al., 2017 ), other studies have found no evidence of this relationship (Berman et al., 1997 ) reporting a preserved capacity for cognitive flexibility in schizophrenia (Greenzang et al., 2007 ; Hilti et al., 2010 ). In this sense, Meiran et al. (Meiran et al., 2000 ) have proposed that the deficits in cognitive flexibility found in patients with schizophrenia (evaluated using task-switching paradigms (Allport et al., 1994 ) could reflect a poorer memory for remembering information from the context of the task rather than a deficit in cognitive flexibility. In their study, although the patients had a higher TSC TR , they were as efficient as controls when executing the task. To test this hypothesis regarding the difficulty to remember the keys that indicate change and their corresponding response, the authors evaluated healthy participants in conditions in which the information about the meaning of the response had to be acquired again on each trial. It was found that these participants showed a task-switching cost pattern similar to that of patients, suggesting that in patients with schizophrenia there could be a difficulty in remembering the instruction that signals the change in task, rather than dysfunction in the TSC.

Regarding the planning task (Tower of Hanoi), our patients only differed from the control group in terms of latency in the short planning trials. Still, they did not make more errors than the controls, suggesting a preserved ability, albeit with slower processing speed. A possible explanation for these results could be found in studies suggesting that cognitive deficits in schizophrenia may be mediated in part by a reduced processing speed that interferes with cognitive performance rather than by cognitive failure itself (Mathias et al., 2017 ; Rodríguez-Sánchez et al., 2007 ).

Alterations in hot EEFF

Regarding the most socio-emotional or hot EEFF, compared with the control group, the patients showed significantly poorer performance on two of the tasks studied: the recognition of facial emotional expressions and the task that evaluates the theory of mind (Hinting Task). These two processes—both the recognition of facial emotions and the recognition of intentions, emotions, and thoughts—are complementary processes that are necessary for adequate social functioning (Jáni & Kašpárek, 2018 ).

In our study, patients demonstrated a poor ability to identify and label facial emotions compared to controls; this was observed both for basic or innate facial expressions and those that are more complex. Therefore, our data suggest that patients with PS may present a marked deficit in identifying and categorizing emotions on the face. Although some studies have related these deficits more to negative symptoms than positive symptoms (Andrzejewska et al., 2017 ; Kohler et al., 2000 ), other studies have reported similar results. The latter found that in patients with PS, there was a generalized deficit in the perception of facial emotions, both in the earliest stages of the disease and in the more chronic stages, highlighting the possibility that this deterioration in the identification of emotions could represent a marker of trait susceptibility, rather than being a sequela of the disease (Barkl et al., 2014 ; Chan et al., 2010 ).

Mixed results can be found in the current scientific literature regarding the deficits that patients present in theory of mind (ToM). Some meta-analyses have found no clear affectation of ToM in patients with PS (Chan & Chen, 2011 ; Ventura et al., 2010 ), while other studies have found that patients show over mentalization in which an excessive and inaccurate attribution of mental state goes beyond the social cues provided (Abu-Akel, 1999 ; Fretland et al., 2015 ; Wastler & Lenzenweger, 2020 ). In a similar vein, the neurocognitive model developed by Frith (Frith, 2004 ) suggests that although patients with marked PS have an intact ToM in the sense of understanding that other people have mental states, they show poor performance due to difficulties in accurately monitoring and using contextual information, leading them to make incorrect inferences about the mental states of others. According to the model, these difficulties would lead to a breakdown in communication and eventually to a formal thought disorder and difficulties in distinguishing between subjectivity and objectivity, in addition to holding false beliefs in the form of delusional convictions. Our results, therefore, are in line with those studies that highlight ToM involvement in patients with a predominance of PS since, compared to the control group, our patients showed a significantly poorer ability to infer the true intention of indirect speech.

Regarding the clinical variables analyzed (years of evolution of the disease, clinical treatment device, and type of pharmacological treatment), we only found differences concerning the variable years of disease evolution . These differences were observed only in the planning task (Tower of Hanoi) of the cool , where patients with a short disease evolution (less than 11 years) made fewer errors in the short planning condition (less than five movements are required to complete the model) compared to the group with long disease evolution (more than 11 years). Subsequent analyzes with the control group revealed that patients with a short disease evolution showed similar performance to controls. This finding could suggest that, in patients with shorter disease evolution, the deficits in planning could be less severe or are more preserved in the earlier stages but deteriorates as the disease progresses, showing greater involvement.

Positive symptoms and hot and cool EEFF

Regarding the relationship between PS and performance on EEFF tasks, the Formal Thought Disorder symptom showed a significant correlation with performance on both cool and hot executive functions tasks. Specifically, this symptom was positively correlated with cognitive flexibility and planning and negatively correlated with ToM. The bizarre behavior symptom was only positively correlated with working memory, and the delusional symptom was negatively correlated with planning.

These results highlight the importance of EEFF of a more cognitive or cool type in PS, particularly in WM. Although we also found correlations with cognitive flexibility, and with planning, in this sense, it is also interesting to note that the correlation with planning was observed in the reaction time condition, which could suggest that in these patients, there is a marked decrease in the processing speed that could interfere with performance on the task (Mathias et al., 2017 ).

Regarding the correlation found between formal thought disorders and ToM, our results are in line with the suggestions of authors such as Frith (Frith, 2004 ) and Corcoran (Corcoran, 2004 ), where formal thought disorders, such as the use of neologisms, excessive use of pronominal referents, rigid thinking, and idiosyncratic speech, arise from not considering the state of knowledge of other people. These patients, therefore, do not recognize the difference between their state of knowledge about a subject and the state of knowledge of the other person. This difficulty in separating the two states of knowledge would thus be manifest in a significant failure of ToM.

Finally, it is worth highlighting our findings from the perspective of the three-dimensional model described by Liddle et al. (Liddle & Morris, 1991 ) In this model, the PS of schizophrenia include two different factors, one related to the distortion of reality ( hallucination symptoms and delusions ), and a disorganizing factor (e.g., formal thought disorder and bizarre behavior ). The disorganization symptoms are those that would present a stronger relationship with the neurocognitive deficits in comparison with distortion of reality symptoms (Cuesta & Peralta, 1995 ; Ventura et al., 2010 ). Similarly, in our study, disorganization symptoms were most strongly correlated with performance on both cool and hot executive EEFF tasks compared with distortion of reality symptoms. Therefore, these results could suggest that within the dimension of PS, there are two types of symptoms that differ in terms of cognitive functioning.

Frontal behavioral syndromes and positive symptoms

Concerning the issue of whether the patients with PS present any of the three frontal behavioral syndromes, we found that a large percentage of our patients presented a clinically significant score on the three syndromes. A high score (> 65) in the subscales that make up the FrSBe test is a robust indicator of behavioral abnormalities related to the frontal system (Grace & Malloy, 2001 ). Therefore, as we expected, our results point to a possible affectation of the three fronto-subcortical circuits in this population. A higher percentage of the patient group appeared to suffer from Dorsolateral syndrome (81.5%) and Anterior Cingulate syndrome (77.8%), while 59.3% also presented high scores for Orbitofrontal syndrome . Similar results were reported by Ruiz-Castañeda et al. (Ruiz-Castañeda et al., 2020 ) in patients with schizophrenia with a predominance of negative symptoms (see Appendix 1). In this study, a high percentage of patients with a predominance of negative symptoms also presented clinically significant scores for the three syndromes, particularly Dorsolateral syndrome (72.20%) and Anterior Cingulate syndrome (69.70%), while a lower percentage indicated the presence of Orbitofrontal syndrome (33.30%). This could suggest that in schizophrenia, patients also have a wide variety of behavioral abnormalities related to the involvement of the fronto-subcortical circuits.

Dorsolateral syndrome is mainly characterized by the presentation of problems in EEFF. Our patients, therefore, showed a wide variety of behaviors resulting from this syndrome, such as the difficulty to anticipate future events; the inability to use strategies to retain information and put it to proper use; in addition to difficulties when performing more than one task at the same time. Our patients also showed difficulty in self-reflection and monitoring of their behavior along with an inability to adjust their behavior according to the feedback provided by other people.

Regarding Anterior Cingulate syndrome, our patients presented behaviors related to poor initiation, psychomotor retardation, persistence, loss of energy and interest, personal hygiene problems, and apathetic behaviors. Regarding the Orbitofrontal syndrome, a part of our sample reported an inability to inhibit actions or behaviors appropriately; these patients reported impulsive, hyperactive, and socially inappropriate behaviors, as well as a difficulty to modulate their emotional states, presenting poor emotional control including emotional lability or irritability.

Implications and conclusions

The main findings of our study, following our proposed objectives, are described below. First, patients with a predominance of PS in schizophrenia presented specific deficits in cool and hot EEFF in comparison with healthy controls. The patients showed poorer performance on all the cool EEFF explored (WM, cognitive flexibility, and planning), with a larger effect size observed in WM. Regarding the hot EEFF, they showed worse performance in recognition of emotions and ToM. However, our patients did not show differences in the Iowa Gambling Task that assesses decision-making under conditions of uncertainty. Performance on this task has been consistently implicated in adequate functioning of the orbitofrontal area of ​​the brain. In this sense, it is interesting to note that compared to the Dorsolateral and Anterior Cingulate syndrome, a lower percentage of our patients showed clinically significant behaviors associated with Orbitofrontal syndrome; therefore, a possible explanation for our results could be the conservation of this brain area in our sample of patients.

Regarding the influence of clinical variables , patients with a short disease evolution showed better execution of planning than patients with a long evolution. No difference was observed in the execution of the tasks depending on the type of clinical device to which the patients belonged or the psychopharmacological treatment.

Regarding the relationships between PS and poor performance in executive functioning, it was the formal thought disorder symptom that showed a significant correlation with performance on both cool and hot EEFF tasks. Specifically, this symptom correlated with cognitive flexibility, planning, and ToM. The bizarre behavior symptom only correlated with working memory, while both hallucinations and delusions were related to planning.

Concerning the three frontal behavioral syndromes (Dorsolateral, Orbitofrontal, and Anterior Cingulate), we found that a high percentage of our patients presented all three syndromes, the most prevalent being Dorsolateral syndrome (81.5%), followed by Anterior Cingulate (77.8%), and Orbitofrontal syndrome (59.3%).

Finally, we consider that our findings make a significant contribution to the literature in several ways:

There is a scarcity of studies in the literature that explore EEFF in patients with schizophrenia distinguished according to the predominance of positive versus negative symptoms. This approach offers the advantage of analyzing more precisely the relationship between clinical symptoms and EEFF, avoiding the rigidity implied by a nosological classification of schizophrenic disorder.

A further contribution of this work comes from our attempt to explore in more depth the EEFF in patients with schizophrenia by analyzing both the cool and hot components. The advantage of adopting this perspective is that it allows us to take a finer approach to determining the neuropsychological involvement in the functions studied, which will inform the development of appropriate neuropsychological and psychotherapeutic interventions for this patient population.

Another noteworthy aspect of this study is the measurement instruments used. We have employed a battery of computerized neuropsychological tasks based on experimental paradigms developed within cognitive neuroscience. These evaluative instruments allow us to obtain valid and precise measurements of the patient's performance under study. They also allow the study to be replicated with other populations for comparison of results.

Finally, another important aspect to emphasize is the involvement of fronto-subcortical circuits in patients with PS. Studies of other populations have reported that these circuits are altered in, for example, patients with brain damage. However, to our knowledge, this is the first study to explore the links between behavioral abnormalities related to the frontal system and the PS of schizophrenia.

Limitations

This study must be viewed in light of several limitations. First, a small sample was used, which could reduce the statistical power of our study. Second, the study was not carried out using the blind method because the recruitment and subsequent evaluation of the patients were carried out in the hospital context, so the evaluator knew the clinical characteristics of the participant. However, and to have greater control over the presentation of stimuli and the collection of responses and thus minimize the influence of evaluator biases, the study used an extensive battery of computerized neuropsychological tests to evaluate both hot and cool executive functions.

Finally, regarding the clinical variable of pharmacological treatment, the sample was not divided according to an estimate based on chlorpromazine equivalents. And although we found no differences in performance on the EEFF tasks according to the medication they were taking at the time of the evaluation ((1) medicated patients vs. patients without medication; (2) typical and atypical vs atypical/without medication), our results should be interpreted with caution, since some studies have highlighted the possible beneficial effects of atypical medications on general cognitive functioning (Buchanan et al., 1994 ; Meltzer & McGurk, 1999 ; Purdon et al., 2000 ). However, according to Harvey et al. (Harvey & Keefe, 2001 ), some of these studies used poor methodologies, and their results should be regarded as preliminary, requiring replication in further studies conducted with higher methodological standards.

Availability of data materials

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank the patients belonging to the mental health facility of the Torrecárdenas Hospital, who kindly decided to participate in this investigation. We also thank the mental health professionals for their cooperation in the referral of patients for this study.

Significance statement

Executive function (EEFF) deficits in schizophrenia have been associated with a deterioration in the quality of life of patients that affects their ability to lead an independent and socially productive life. However, to date, there is no clarity on the specific deficits that patients with positive symptoms (PS) present in FFEE. One way to deepen their study is to analyze the cognitive and socio-emotional components of these functions through experimental paradigms of cognitive neuroscience. On the other hand, EEFF have been associated with the functioning of the prefrontal cortex, so it would be expected that these patients would present clinically significant scores in any of the three fronto-subcortical behavioral syndromes: Dorsolateral, Orbitofrontal, or Anterior Cingulate. We present the first study that addresses the specific deficits of cognitive and socio-emotional EEFF and the presence of fronto-subcortical behavioral syndromes in patients with schizophrenia with a predominance of PS. Our results suggest the presence of specific executive deficits, presenting a greater deterioration of the cognitive component of working memory, and of the socio-emotional components of facial expression recognition and theory of mind. Symptoms of “disorganization” are those that are more closely related to FFEE than symptoms of “distortion of reality.” Finally, we report the presence of the three fronto-subcortical behavioral syndromes in this population. It shows the importance of implementing neuropsychological treatments that consider specific aspects of the FFEE that affect the adaptation of the patient to their environment and help to improve her quality of life.

This research was supported by the program for publication in open access journals from the Research and Transfer Plan 2021 of the University of Almería.

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Pamela Ruiz-Castañeda & María Teresa Daza González

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Encarnación Santiago Molina

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PR-C, MD, and ES-MS formulated the original idea and designed the experiments, interpreted the data, and wrote the first draft of the manuscript. HA-L and PR-C conducted the statistical analysis. PR-C, MD, ES-M, and HA-L approved the final manuscript. All the authors contributed to the article and approved the submitted version. All authors read and approved the final manuscript.

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See Fig.  4 .

Percentage of clinically significant cases in fronto-subcortical syndromes in patients with positive and negative symptoms. The negative symptom scores have been adapted from the study of Ruiz-Castañeda et al. ( 2020 )

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Ruiz-Castañeda, P., Santiago Molina, E., Aguirre Loaiza, H. et al. Positive symptoms of schizophrenia and their relationship with cognitive and emotional executive functions. Cogn. Research 7 , 78 (2022). https://doi.org/10.1186/s41235-022-00428-z

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• Cognitive executive functions; Socio-emotional executive functions; Schizophrenia
• Positive symptoms
• Fronto-subcortical syndromes

ORIGINAL RESEARCH article

Can industrial intelligence promote carbon emission efficiency --empirical research based on the yangtze river economic belt.

• 1 School of Economics, Management and Law, University of South China, Hengyang, China
• 2 School of Management, China Institute for Studies in Energy Policy, Xiamen University, Xiamen, Fujian, China
• 3 School of Economics and Finance, South China University of Technology, Guangzhou, China

The rapid development of intelligent technology characterized by robots under the fourth scientific and technological revolution provides a favorable opportunity for the accurate decision-making of urban pollution control and the effective achievement of the goal of carbon emission reduction in China. This research uses the robot penetration rate as a representative and characteristic index of industrial intelligence development, based on panel data from 108 cities in the Yangtze River Economic Belt (YEB) from 2006 to 2020. It then uses panel quantile regression, spatial measurement, and threshold effect models to provide a more thorough theoretical and empirical discussion of the impact, mechanism, and spatial effect of industrial intelligence development on urban carbon emission efficiency (CEE). Urban CEE may be greatly increased with the use of industrial intelligence, and this finding remains true even after endogeneity and robustness tests are controlled; From an action mechanism perspective, industrial intelligence advances technology, optimizes industrial structure, and ultimately enhances regional CEE; There is a Matthew effect on the degree of development of carbon emission efficiency, and the impact of industrial intelligence on CEE is more pronounced in non-resource-based cities and the lower portions of YEB; Urban CEE increases positively with the spatial spillover impact of industrial intelligence development. The ability for regional sustainable development will be significantly increased if cross-regional cooperative prevention and control of environmental governance can be successfully achieved. This study verifies the enabling effect of industrial intelligence development on the improvement of urban CEE, and provides enlightenment for China to improve industrial intelligence development strategies and policies to achieve regional high-quality development.

1 Introduction

China’s economy has expanded at an average annual pace of 9.4% since the reform and opening up, resulting in “The Chinese miracle”. Yangtze River Economic Belt (YEB) is an important economic region in China, it crosses three Chinese regions and contributes more than 50% of China’s annual economic growth, is a key strategic area for China’s economic development. Nevertheless, the ecological environment of the provinces and cities along the Yangtze River is under peril due to the economy’s fast development. Chinese President Xi Jinping has convened three meetings to emphasize the need to achieve high-quality economic development in China, and Chinese government put forward the commitment of independent emission reduction in the Paris Agreement in 2016 in an attempt to control greenhouse gas emissions. In 2020, China’s carbon emissions per unit of GDP decreased by 48% compared with 2005, exceeding the target of 40%–45% promised to the international community, however, there is still a long way to go. Faced with the increasingly challenging situation of carbon dioxide emission reduction in China, YEB, as a pilot Chinese ecological civilization region and a link for the coordinated development of East, Central and West China, needs to shoulder the dual responsibilities of economic development and environmental protection. That is, to find a green growth path that takes into account both ecological environment and economic growth, and to realize the steady economic growth and “carbon peaking and carbon neutrality” goals. The key to achieving the above goals lies in YEB’s ability to obtain maximum output with minimum material resource input and ecological resource cost, i.e., to improve YEB’s urban carbon emission efficiency (CEE), which is directly related to the implementation of the national High-quality economic development and the realization of the future “carbon peaking and carbon neutrality” goals.

At this stage, a significant industrial intelligence development trend has emerged globally, which has a revolutionary effect on the economic activities of enterprises. This trend is brought about by the ongoing breakthroughs in information and communication, new materials, new energy ( Graetz and Michaels, 2018 ). The White Paper on China’s Industrial Intelligence in 2019 points out that industrial intelligence is the output increment brought by the use of artificial intelligence (AI), Internet of Things, Internet and other technologies in the primary, secondary and tertiary industries. It liberates manpower by replacing simple repetitive work, provides a brand-new human-computer interaction mode, and breaks through the limits of human beings to innovate new industrial species. It can be said that industrial intelligence is essentially subverting people’s production and lifestyle. Through the automation of knowledge work, man-machine interaction and collaborative intelligence in product life cycle manufacturing activities, it realizes the optimization of product life cycle manufacturing process, thus promoting the optimization of industry factor endowment conditions and the innovation of production mode, and inevitably having a noticeable impact on urban CEE as the carrier of economic activities and industrial space. As a result, the widespread application of smart technologies in the industry holds great promise for the Chinese region to achieve the sustainable development goals ( Vinuesa et al., 2020 ). It makes sense to bring the realistic background of industrial intelligence development into the policy consideration of improving the path of CEE, deeply reveal the influence effect and internal logic of industrial intelligence development on CEE, and discuss how industrial intelligence development can promote CEE.

2 Literature review

With the rise of Industry 4.0 Revolution, the impact of industrial intelligence on economy and society has aroused extensive discussion in academic circles ( Goralski and Tan, 2022 ), and related research has produced substantial results on the economic growth effect and environmental impact effect of industrial intelligence respectively. Regarding the impact of industrial intelligence on economic growth, existing studies have come up with consistent and positive findings on the features of industrial intelligence that foster efficiency enhancement, technical innovation, and industrial revolution. For instance, labor can be supplemented and replaced in repetitive tasks and standardized processes by integrating artificial intelligence with manufacturing ( Mikalef and Gupta, 2021 ); Labor productivity may be promoted to support economic growth, and intelligent production and management can be achieved by optimizing production control decisions through independent control ( Kromann et al., 2020 ). Industrial intelligence can contribute to economic development by reshaping innovation processes, increasing the capabilities of R&D organizations and generating spillover effects through the application sector ( Ding et al., 2023 ). Jin et al. (2022) pointed out that the application of artificial intelligence technology in greenhouse planting can predict greenhouse meteorological data, accurately guide agricultural production and reduce unnecessary production costs. Industrial intelligence brings intelligent industrialization innovation and industrial intelligence transformation, and at the same time, it can promote the intelligent reconstruction of industrial structure ( Guo, 2019 ); The deep integration of artificial intelligence and traditional industries promotes the digital and intelligent transformation of traditional industries, accelerates industrial differentiation, and promotes the cross, penetration and integration of different industries ( Graetz et al., 2022 ). However, some scholars have also put forward the adverse effects of industrial intelligence on economic growth, including labor market crowding out ( Wang et al., 2022 ), unemployment ( Acemoglu and Restrepo, 2019 ), blind expansion ( Zhao et al., 2022 ) and so on.

Existing studies mainly used the Divisia index method to decompose carbon dioxide emissions in order to analyze the factors affecting carbon emissions ( Raza et al., 2021 ), or mainly studied the impact of the traditional production factors on carbon emissions ( Raza and Lin, 2022 ; Raza and Li, 2023 ). The current study on the effects of industrial intelligence on the environment is mainly focused on the industrial sector. It has conducted both theoretical and practical research on the potential avenues through which industrial intelligence could support low-carbon and green development, with a focus on energy efficiency enhancement, innovation in green technologies, and industrial structure optimization. It is believed that industrial intelligence can integrate intra-industry and inter-industry knowledge and cross-enterprise cooperative innovation ( Barbieri et al., 2020 ), and accelerate knowledge spillover and creation; Promote the absorption and creation of knowledge within enterprises, optimize the decision-making of equipment and materials use ( Zhang et al., 2023 ). The application of artificial intelligence in the industrial field helps to improve energy efficiency and reduce related pollutants ( Sarkar and Sarkar, 2020 ). According to Yuan et al. (2022) , industrial intelligence has the potential to enhance production processes, provide real-time feedback and optimization of production information, minimize energy waste, shorten equipment response times, and drastically close the gap between companies and the most energy-efficient ones; Neural network and machine learning applications can forecast waste production and encourage waste recycling, increasing energy efficiency and lowering emissions of pollutants ( Kopka and Grashof, 2022 ). Additionally, the use of industrial intelligence can help modernize and restructure the industrial structure, advance the growth of clean industries, and remove outdated production capacity ( Shen and Yang, 2023 ); The energy industry may effectively foster the growth of new energy industries, decrease industrial pollution emissions ( Du et al., 2021 ). Some scholars have reservations about whether industrial intelligence can improve the environment. The reason is that although artificial intelligence technology is developing rapidly, only some regions and a small number of enterprises have matching human capital and corresponding intelligent infrastructure at present. In addition, the lag of technology diffusion and the formation of social group consciousness take a long time, which easily makes the production efficiency improvement brought by artificial intelligence technology not obvious, and even crowds out the investment of other departments and easily causes unnecessary waste of resources ( Du and Lin, 2022 ; Liu et al., 2022 ). In the long run, these regions with relatively backward basic conditions cannot share the knowledge dividend brought by artificial intelligence technology equally, which hinders the green development of regional economy, and eventually leads to the Matthew effect that the stronger the strong and the weaker the weak. According to Czarnitzki et al. (2023) and Liu et al. (2020) , industrial intelligence has a “U-shaped” impact on economic intense transformation. Some experts believe that human conduct has a crucial part in determining the direction of environmental change, and that the application mode of industrial intelligence affects this.

In summary, Research exploring the environmental impact effects of industrial intelligence needs to be fleshed out as the trend towards industrial intelligence increases globally; furthermore, existing research has focused mainly on the environmental impacts of intelligent developments in the industrial sector. However, the problem of carbon emissions from primary and tertiary industries in China is equally serious. For example, from 2011 to 2018, China’s tertiary industry carbon dioxide emissions increased by 51.24%, and total agricultural carbon emissions accounted for 17% of total greenhouse gas emissions, higher than the global average of 11% ( Gai and Yang, 2023 ). Because of the numerous problems caused by the depletion of global resources and the mounting demand on enterprises to reduce carbon emissions, it is therefore not sufficient to examine the effects of industrial intelligence on productivity, economic growth, and carbon emissions in isolation. Therefore, even if the secondary industry, including the industrial sector, is the main source of carbon emissions, the growth of carbon emissions from other industries cannot be ignored. It is imperative to study how industrial intelligence affects carbon emission from the perspective of coordinated development of various industries. The theory and methodology of the green total factor productivity (GTFP) index in environmental economics are based on the TFP. GTFP is a significant indicator of the joint performance of economic growth and environmental optimization, represents the ability of the economic system to generate economic output while maintaining environmental quality and ecological balance through production factors like labor, capital, and energy ( Zhan and Li, 2022 ). Only Tang and Chi (2022) , Meng and Zhao (2023) , and Qian et al. (2023) have examined the connection between industrial intelligence and green economic efficiency in the literature that is now in existence. This relationship has to be further refined.

For the reasons listed above, the penetration rate of industrial robots is used in this article as a representative and distinctive indicator of the growth of industrial intelligence, and conducts a theoretical and empirical analysis on the impact and mechanism of CEE of cities empowered by industrial intelligence, based on panel data of 108 cities in Chinese YEB from 2006 to 2020. The possible marginal contributions of this research include: Firstly, this research enriches the research on the relationship between industrial intelligence and the coordinated development of economy and environment, and provides theoretical and empirical evidence from China for exploring the path of improving urban CEE from the perspective of digital technology. Secondly, this research analyzes the heterogeneous impact effect of industrial intelligence on CEE in YEB from the perspectives of geographical location, resource endowment and CEE, and provides more detailed empirical conclusions for policy recommendations. Thirdly, this research verifies the spatial spillover effect of industrial intelligence on urban CEE, and provides theoretical support for the implementation of cross-regional pollution control policies. Fourthly, this research discusses the threshold effect of human capital on the impact of industrial intelligence on CEE, which has important policy implications for breaking the “Matthew effect” between regions and giving full play to the role of human capital in environmental governance. Section 2 is literature review. Section 3 elucidates the theoretical analysis and provides research hypotheses. Section 4 details the methodologies and variable descriptions. Section 5 presents the empirical results. Section 6 is the discussion of empirical results. Section 7 provides conclusion, policy implications and limitations.

3 Mechanism analysis and hypothesis

3.1 analysis of the direct impact of industrial intelligence on urban cee.

Technologies such as machine learning, intelligent robots, computer vision, and deep learning are important forms of artificial intelligence ( Liu et al., 2020 ). With the free flow of cross-border capital in recent years, the application of artificial intelligence technology in industries in emerging economies has been accelerated ( Ma et al., 2023 ). The application of artificial intelligence in the primary industry can transform the traditional production mode of agriculture into an intelligent production model, realize precision planting and breeding, and achieve the goal of low-carbon agricultural development. The integration of artificial intelligence and manufacturing will help break through the limitations of manual supervision process, realize the digital control of the whole production process, and reduce the greenhouse gas emissions of the entire industrial chain ( Wang et al., 2023 ). Industrial intelligence can also optimize urban industrial production conditions, improve the purification accuracy of waste through robot operation, and provide a more scientific and effective basis for enterprise pollution control decisions through pollution data mining and analysis. The application of artificial intelligence technology in the tertiary industry can reduce the carbon emissions of transportation and life services, and improve the CEE of the tertiary industry. Therefore, the following assumptions are put forward:

H1. Industrial intelligence can promote the improvement of urban CEE.

3.2 Analysis of the indirect impact of industrial intelligence on urban CEE

3.2.1 analysis of technological progress channel.

The endogenous growth theory states that the advancement of technology is the primary driver of steady economic growth, and Grossman and Krueger (1991) confirm the key role of technological effect in improving environmental pollution. In the context of industrial intelligence, the traditional labor force is liberated from tedious process work to focus on innovation as well as more valuable strategic activities ( Li, 2023 ), the use of intelligent equipment often requires a high level of knowledge, prompting enterprises to introduce high-quality talent, and to achieve scientific and technological progress through the human capital effect and technological complementary effect ( Yu et al., 2022 ). In addition, AI technology can reduce the cost of information transfer between enterprises, enable enterprises to learn and imitate advanced production technology, expand the capital stock of public knowledge, and drive the technological innovation of upstream and downstream enterprises ( Nishant et al., 2020 ). The use of intelligent technology enables enterprises to continuously improve the added value of their products and gradually replace low value-added enterprises in the industrial value chain, while other enterprises that have not undergone intelligent transformation will continuously update their production technology and management experience through learning and imitation in order to avoid being eliminated ( Bernard et al., 2019 ). Urban industrial energy efficiency can be effectively increased through technological advancements in the areas of industrial resource recycling efficiency, green technology and equipment product supply, and green transformation level of production process. Therefore, the following assumptions are put forward:

H2. Industrial intelligence promotes urban CEE through the channel of technological progress.

3.2.2 Analysis of industrial structure optimization channel

In the process of the intelligent development of industry, digital technology and digital elements are widely applied in all fields of cities’ economy and society, and the rapid development of modern information technology promotes the deepening of the integration of the digital economy and the real economy, giving rise to a series of new products, new technologies and new forms of business, and promotes the continuous upgrading of the industrial structure in the direction of high-end digitization, greening and low-carbonization ( Furman and Seamans, 2019 ). In addition, industrial intelligence can prompt traditional industrial enterprises to gradually eliminate backward production capacity and carry out transformation and upgrading, which is not only an important path to break the dilemma of high pollution, high energy consumption and high emission in the field of industrial economy, but also a typical feature of the optimization and upgrading of industrial structure ( Waltersmann et al., 2021 ). Industrial structure upgrading in the process of industrial intelligent development can accelerate the development of greening and low-carbonization in the whole field of social economy and realize the improvement of CEE. Therefore, this research proposes the following research hypothesis.

H3. Industrial intelligence promotes urban CEE through the channel of industrial structure optimization.

3.2.3 Spatial effect analysis

According to the theory of economic geography, the flow of production factors can gradually break down interregional market segmentation and change the spatial isolation of individual development. This leads to a certain spatial spillover effect in interregional production activities. Digital technologies such as artificial intelligence and big data carried by industrial intelligence can break the geographical distance barrier of information technology transmission, improve the mobility and accessibility of data, and alleviate the barriers of technical exchange between regions, which makes the regions that actively improve the level of industrial intelligence have certain enlightening and learning effects on neighboring regions after achieving economic growth and environmental protection achievements ( Vial, 2019 ), thus promoting the improvement of CEE in neighboring regions. If the spatial spillover effect is disregarded, the overall benefit of industrial intelligence on CEE may be underestimated. Based on this, this research proposes the following research hypothesis.

H4. Industrial intelligence may have spatial spillover effects on carbon efficiency in neighboring regions.

4 Methodology and variable definitions

4.1 model setting.

The empirical research in this paper aims to effectively identify the impact of industrial intelligence on urban CEE, so we set the following benchmark regression model based on the above theoretical mechanism analysis and research hypotheses:

Where C E E it represents the CEE of city i in the year of t , and the core explanatory variable I R obot it denotes the robot application degree of city i in the year of t . The estimated coefficient β 1 before I R obot it portrays the effect of changes in industrial intelligence on urban CEE, if β 1 > 0, it indicates that urban industrial intelligence improves urban CEE. Meanwhile, in order to make the empirical results more robust, this research controls as much as possible other factors affecting the urban CEE, which mainly include: the intensity of environmental regulation, the level of urbanization, foreign direct investment, the size of the population, the government intervention, and the level of financial development. In addition, in order to eliminate the possible interference of unobservable and time-varying factors at the city level on the regression results, the city fixed effect μ i and year fixed effect λ t are added into the model, ξ it is random error terms.

To further discuss the spatial spillover effect of urban industrial intelligence on urban CEE, the spatial interaction terms of the explanatory variables are introduced into Eq. 1 to construct the following spatial measurement model:

In Eq. 2 , W is the spatial weight matrix, which is constructed by the geographical structure difference distance between two cities. On account of the limitation of constructing the weight matrix only by geographical distance, subsequent spatial econometric regressions were performed using the adjacency matrix and the economic distance matrix respectively to ensure the robustness of the results. ρ is spatial autocorrelation coefficient, δ is the spillover effect of industrial intelligence, γ 2 is the spillover effect of control variables. According to whether the values of ρ , δ , γ 1 and λ are significantly 0, spatial econometric models can be divided into three categories: if ρ = δ = γ 1 = 0, the models are spatial error models (SEM); If δ = λ = 0, the model is spatial lag model (SLM). If λ = 0, the model is spatial Durbin model (SDM). Later, the above models will be selected through further inspection.

4.2 Variable definitions

4.2.1 core explanatory variable: urban industrial intelligence level ( l n i r o b o t ).

Referring to the methods of Acemoglu and Restrepo (2019) , Xu and Song (2023) , this research construct the robot application index at the city level using the industrial employment structure of the city, the number of working-age laborers in the city and the number of robots at the industry level. This method comprehensively considers the characteristics of urban labor force, the scale characteristics of industrial labor force and the application scale of urban robots, and is more scientific compared with the direct use of the robot data. Specific measurement formula is shown in Eq. 3 :

In Eq. 3 , i means city, j denotes industry, t means year, s represents different sectors among the three industries, and based on data availability, six industries including agriculture, mining, manufacturing, electricity, gas, water and gas supply, construction and education are selected. R o b o t s j t indicates the number of robots used in various industries in China from 2006 to 2020, L a b o r i , t denotes the total number of people employed in the three industries in year t of city i , E m p s i , t indicates the amount of laborers in the above six industries in year t of city i , and ∑ j E m p j i , t denotes the total number of people employed in the three industries in year t of city i . To facilitate reporting the research results, we multiply I R o b o t i t by 0.1.

4.2.2 Explained variable: C E E

Referring to the existing literature ( Sun and Huang, 2020 ; Yu and Zhang, 2021 ), this research adopts total factor productivity (TFP) to measuring C E E , in which input indicators mainly include resources and factors, expected output indicators mainly include economic and environmental indicators, and non-expected output indicator are carbon dioxide emissions. The specific input-output indicators are shown in Table 1 .

Table 1 . Input and output variables of CEE measurement.

Due to the lack of detailed urban energy consumption data, this research draws on the methodology of Chen et al. (2020) and uses NPP-VIRS nighttime lighting data to derive carbon emission data for Chinese cities. In recent years, measuring carbon emissions based on NPP-VIIRS night light data has been widely used in economic research ( Zhang et al., 2019 ; Ismael, 2021 ). The basic logic is that the higher the brightness of lights at night, the more active the city’s night-time economic activities are, and the higher the energy consumption will be. Specifically, considering the accuracy of the downscaling model inversion, a linear model is adopted to fit the carbon emission data, and the results of the correlation test between the carbon emission estimates and the statistical values of each province are shown in Figure 1 . There is a linear correlation between carbon emission estimates and statistics, and the goodness of fit R 2 is about 0.8, indicating that the method of deduction of carbon emissions by night light data is scientific and effective.

Figure 1 . Carbon emission fitting.

4.2.3 Tool variables: U.S. Robot use A M I R o b o t

Considering that cities with higher C E E often have a higher level of digital infrastructure, which in turn facilitates local industries to undergo smart transformation and enhance industrial intelligence, so there may be a problem of two-way causality. Therefore, this research uses U.S. industry-level robotics data to construct the instrumental variable A M I R o b o t s i t as shown in Eq. 4 for the following reasons: Firstly, although the application level of American robots is ahead of China in the sample period, the stock and penetration of robots are close to that of China in the same period; Secondly, the application level of robots in the United States is in a leading position in the world, and its development trend can reflect the trend of technological progress to a certain extent; Thirdly, the labor market in the United States has a high level of development, which makes it easier to meet exogenous conditions ( Huang et al., 2023 ; Zhao et al., 2024 ).

4.2.4 Control variables

Referring to relevant studies ( Du et al., 2022 ; Huang et al., 2023 ), this study includes the following control variables. Environmental regulation e r , referring to the study of Zhang and Chen (2021) , measured by the ratio of environmental word frequency in in city government reports to the total word frequency in city government reports. Population size ( p o p ), measured by the natural logarithm of the resident population at the end of the year. Foreign direct investment f d i , expressed as the proportion of foreign capital actually used to GDP. Government intervention g v , measured by the proportion of government fiscal expenditure to GDP. Financial development f i n , expressed by the proportion of deposit and loan balance of financial institutions to GDP. The level of urbanization u r b a n , measured by the ratio of urban resident population to rural resident population.

4.2.5 Mechanism variables

In accordance with the above analysis, the mechanism effects of this research mainly include technological progress and industrial structure optimization. Technological progress variables are expressed as the number of green innovation l n g p t and quality of green innovation l n g p q , measured by the logarithm of the total number of urban green patent applications and the logarithm of the total number of urban green invention patent applications, respectively. Also, to facilitate the reporting of regression results, the final value of the indicators is multiplied by 0.1. Optimization of industrial structure variables are expressed as rationalization and upgrading of industrial structure. The former is measured by the ratio of output of the tertiary industry to that of the secondary industry i n d , and the latter is measured by the T L , where the smaller the Theil index, the more rational the industrial structure and the greater the coordination between industrial sectors. Tables 2 , 3 are variable description and descriptive statistical analysis respectively.

Table 2 . Variable descriptions.

Table 3 . Descriptive statistics.

4.2.6 Data sources

The robot data comes from International Federation of Robotics (IFR), a database that shows the annual increase and inventory of robots in manufacturing, agriculture and certain service industries in 75 countries. Other variables were derived from the National Intellectual property Patent database and the China City Statistical Yearbook.

5 Analyses and empirical findings

5.1 baseline regression analysis.

Table 4 displays the results of the baseline regression. It is evident from columns (1) to (4) that industrial intelligence positively affects urban CEE in YEB, and the effect is significant at the 1% significance level, proving that industrial intelligence can significantly promotes urban CEE, and Hypothesis 1 is confirmed.

Table 4 . Baseline regression results.

5.2 Robustness test

5.2.1 endogenous treatment.

This research takes the U.S. robotics data measured in Eq. 4 as an instrumental variable for the regression, and the results are shown in Table 5 . The Anderson LM test is significant at the 1% level, and the value of Cragg-Donald Wald F statistic is 76.364, which is greater than the critical value of 16.38 corresponding to the maximal IV size at the 10% critical value of the Stock-Yogo test, so it can be considered that this instrumental variable is appropriate. After considering endogeneity, the second-stage regression results show that the regression coefficient of the impact of industrial intelligence on urban CEE is significantly positive at the 1% significance level, which is consistent with the baseline regression results but larger than the baseline regression coefficients, which indicates the robustness of the baseline regression results, and suggests that failing to take into account endogeneity underestimates the effect of industrial intelligence on urban CEE.

Table 5 . Regression results of instrumental variables.

5.2.2 Alternate explanatory variable

We re-run the regression using the incremental robot data as explanatory variables. Logically, if the stock of robots in the urban industrial subsector can have a positive impact effect on the urban CEE, the incremental robots in the urban industrial subsector can have a positive effect as well. The International Federation of Robotics (IFR) reports both the stock data and incremental data of robot use in China. The regression results are shown in column (1) of Table 6 . After regressing with incremental data as an explanatory variable, the coefficient value is still significantly positive, indicating the robustness of the benchmark regression results.

Table 6 . Robustness test results.

5.2.3 Lagging one-stage regression treatment

Considering that there may be a time lag in the role of industrial intelligence in improving CEE in cities, the following regression is conducted with the core explanatory variables of urban robot application rate lagged by one period, and the results are shown in column (2) of Table 6 . The coefficient value in front of the explanatory variables is still significantly positive, which verifies the robustness of the baseline regression results.

5.2.4 Tailing treatment

In order to exclude the influence of extreme outliers, this research shrinks all the extreme outliers of continuous variables at the upper and lower 1%, and then reruns the regression estimation, and the results are shown in column (3) of Table 6 , which shows that industrial intelligence positively influences urban CEE at the 1% significance level, verifying the robustness of the baseline regression results.

5.3 Heterogeneity analysis

5.3.1 regional heterogeneity analysis.

The YEB in China is a vast area, and each city has different degrees of economic development and industrial intelligence development level. For example, Zhejiang, Jiangsu, Anhui, Shanghai in the downstream area of the YEB are the largest digital economy regions in China, with the scale of the integrated circuit industry accounting for 58.3% of China, and their AI industry accounting for 33.0% of AI industry in China. Furthermore, the market competition in the downstream area of YEB is better with fewer constraints to the development of industrial intelligence compared with other areas of YEB. Therefore, this research then divides the samples into two sub-samples of upstream and midstream, downstream regions to investigate the regional heterogeneity of the impact of industrial intelligence on urban CEE in YEB, and the results are shown in Columns (1) to (2) of Table 7 . The results show that industrial intelligence in the upstream and midstream regions of the YEB does not have a significant effect on urban CEE, but industrial intelligence in the downstream region of the YEB significantly and positively improves urban CEE.

Table 7 . Heterogeneity analysis I.

5.3.2 Resource endowment heterogeneity analysis

We then divide the samples into resource cities and non-resource cities to investigate the differential impact of industrial intelligence on CEE in YEB under the condition of heterogeneity of resource endowment, and the results are shown in Columns (3) to (4) of Table 7 It shows that the impact coefficients of industrial intelligence on the non-resource cities are significantly positive, and the impacts on the resource cities are not significant. The reason may be that, the economic growth of resource cities relies heavily on value-added, low technological level and high energy consumption based on the theory of “resource curse” and “comparative advantage trap”, which restricts the enhancement of CEE of resource cities in the YEB empowered by industrial intelligence.

5.3.3 CEE heterogeneity analysis

We then use panel quantile regression to test the heterogeneous effect of urban industrial intelligent development on CEE at different CEE levels. Table 8 shows that the regression results are not significant only for the samples at the 10% quartile level, which indicates that the development of industry intelligent has a positive effect on the improvement of urban CEE in most cases. Moreover, there is a “marginal increase” in the impact coefficient as the quartile rises, that the estimated coefficient at the 25% quantile is significantly smaller than the estimated coefficient at the 90% quantile, which indicates that the empowering effect of industrial intelligence is more obvious for cities with higher levels of CEE, and there is the “Matthew effect” of carbon reduction in cities.

Table 8 . Heterogeneity analysis II.

5.4 Expanded research

5.4.1 threshold effect analysis.

We then take the level of urban digital human capital as a threshold variable to further explore the threshold effect of industrial intelligence on CEE in the YEB. Specifically, the number of employees in the sectors of information transmission, computer services and software are used to measure urban digital human capital. The results in Table 9 show that when the level of digital human capital is lower than the threshold value of 9.135, the CEE effect brought by industrial intelligence is not significant, when the level of digital human capital is greater than the threshold value of 9.135, the regression coefficient is 0.118 and passes the test of 1% significance level. It can be seen that there is a digital human capital threshold for the CEE effect of industrial intelligence in YEB, and industrial intelligence has a significant positive effect on CEE only when it crosses the threshold of digital human capital, and the effect value will show an upward trend with the improvement of the digital human capital level.

Table 9 . Threshold effect results.

5.4.2 Spatial spillover effect analysis

We further explore whether the effect of industrial intelligence on urban CEE in YEB has spatial spillover effects. We first test the spatial autocorrelation of industrial intelligence and urban CEE variables. The M o r a n ′ s index was used to verify the spatial autocorrelation of the main variables under the geographic distance matrix. As shown in Table 10 that industrial intelligence and urban CEE are significantly positive at the 1% significance level from 2006 to 2020, indicating that the level of industrial intelligence and urban CEE in YEB have significantly positive spatial autocorrelation. The spatial econometric model is further used to identify whether industrial intelligence has a spatial spillover effect on the urban CEE, and the Hausman test as well as the LR and LM tests show that the Spatial Durbin Model (SDM) should be used for the estimation of the spatial spillover effect. In order to ensure the robustness of the regression results, the neighbor matrix and economic distance matrix are also added for spatial econometric regression. The final results of the spatial econometric regression are shown in columns (1)–(3) of Table 11 , that the autoregressive coefficient of the urban CEE is positive at the 1% significance level, and the coefficient of the spatial weighting term W is significantly positive, which indicates that the CEE in YEB is not only affected by the local industrial intelligence level, but also by the industrial intelligence level of the neighboring regions.

Table 10 . Moran’s I test.

Table 11 . Regression results of spatial Durbin model.

5.5 Mechanism analysis

Based on the above theoretical analysis and hypothesis, this research examines the mediating mechanisms through which industrial intelligence affects urban CEE from the perspectives of technological progress and industrial structure optimization, respectively. We set up the mediated effect test model as shown in Eqs 5 , 6 :

M e d i i t is the mediator variable, which represents the variables of technological progress and industrial structure optimization respectively. Eq. 5 is used to test the effect of industrial intelligence on the mediator variable, and Eq. 6 is used to test effect of the mediator variable in the process of industrial intelligence affecting urban CEE. In addition, to improve the precision of the mediation effect test, this research uses the Bootstrap method to test the significance of the mediation effect, and the results of the Bootstrap test (500 samples) are also reported in Tables 12 , 13

1. Mechanism test of technological progress. Theoretically, industrial intelligence can not only enhance the technological innovation ability of related industries, but also enhance the green technology efficiency of other industries through the inter-industry “demonstration effect”, thus generating vertical technology spillover effects, which will help to improve the overall scientific and technological level of the city, and ultimately contribute to the enhancement of the efficiency of the city’s carbon emissions. The results in columns (1) and (2) of Table 12 show that industrial intelligence can significantly promote urban green innovation, regardless of whether the explanatory variables are the quantity of green innovation ( l n g p t ) or the quality of green innovation ( l n g p q ). The results in columns (1) and (2) of Table 13 show that the technological progress variables characterized by both dimensions have a significant contribution to urban CEE, and the coefficients of the cross-multiplier terms of the Bootstrap test are all significantly positive, which indicates that industrial intelligence can enhance the urban CEE through the pathway of technological progress, and accordingly, Hypothesis 2 is verified.

2. Mechanism test of industrial structure optimization. Theoretically, industrial intelligence uses various advanced technologies such as edge computing, digital simulation, artificial intelligence, etc., which can eliminate energy waste in the production and manufacturing system, improve resource utilization efficiency and the degree of inter-industry synergy, and contribute to the improvement of the urban CEE. The results in columns (3) and (4) of Table 12 show that industrial intelligence can significantly promote industrial structure upgrading i n d and industrial structure rationalization T L , and the results in columns (3) and (4) of Table 13 show that the industrial structure upgrading i n d and industrial structure rationalization T L can significantly improve the urban CEE, that the optimization of industrial structure plays a mediating role in the process of industrial intelligence affecting urban CEE, and Hypothesis 3 is verified.

Table 12 . Mechanism analysis I.

Table 13 . Mechanism analysis II.

6 Discussion

In this research, we have verified through theoretical and empirical research that industrial intelligence has a positive effect on improving CEE, and this conclusion remains valid after a series of robustness tests. We now discuss the main findings below.

First of all, this research constructs a linear regression model by taking CEE as an explanatory variable, taking industrial intelligence level as an explanatory variable, and adding a series of control variables. The regression results show that CEE increases significantly as the level of industrial intelligence increases. Among the control variables, only the level of financial development is not significant in the final regression results.

Secondly, this research proves the robustness of the benchmark regression results by a series of robustness testing methods, including instrumental variable method, replacement of explanatory variables, lag of explained variables, tail reduction treatment, etc.

Thirdly, this research carry out heterogeneity analysis from the perspectives of the level of regional economic development, regional resource richness and CEE level. It is found that the carbon emission reduction effect of industrial intelligence only exists in the lower reaches of the Yangtze River and non-resource-based cities ( Mao et al., 2023 ). At the same time, through quantile regression method, it is found that there exists a “Matthew effect” in promoting industrial intelligence to improve CEE ( Wang et al., 2024 ).

Fourthly, this research takes the level of urban digital human capital as a threshold variable to further explore the threshold effect of industrial intelligence on CEE in the YEB, by using the threshold effect model, it is found that only when the level of human capital breaks through a certain threshold value can industrial intelligence significantly promote the improvement of CEE ( Tian et al., 2024 ).

Fifthly, this research also tests the spatial spillover effect of industrial intelligence affecting CEE by building a spatial econometric model and conducting a relevant regression analysis ( Lin and Xu, 2024 ). The results of the application of the inverse distance matrix, the economic distance matrix and the nested matrix all indicate that, the improvement of CEE brought about by industrial intelligence has a certain spatial spillover effect.

7 Conclusion and policy implications

7.1 conclusion.

This research comprehensively uses panel econometric model, mechanism test model, tool variable method, and spatial econometric model to analyze and identify the mechanism and effect of industrial intelligence on CEE in YEB. The results found that: 1. YEB’s CEE improves greatly with the development of industrial intelligence, and this conclusion remains steady during a series of robustness tests; 2. Technological progress and industrial structure optimization are intermediary mechanisms for industrial intelligence to promote CEE growth; 3. The impact of industrial intelligence on reducing carbon emissions is especially noticeable in the downstream region of the YEB, non-resource-based cities, and cities with higher CEE; 4. The growth of urban industrial intelligence has had a substantial beneficial impact on nearby cities’ CEE; in other words, there is a positive spatial spillover effect from the development of industrial intelligence on the enhancement of urban CEE; 5. There is a digital human capital threshold for the CEE effect of industrial intelligence in YEB, promote urban digital human capital will help to enhance the driving effect of industrial intelligence on carbon emission reduction in YEB.

7.2 Policy implications

Firstly, accelerating the development of industrial intelligence in cities in YEB is an important path to realize the green transformation and upgrading of the regional economy, the government should promote the integration of intelligent development models with traditional industries, build green production and service models, and apply policies to create a fair competitive market environment. The government should also increase its investment in the fields of science, technology, engineering and mathematics to train the professionals needed for the smart industry and provide strong talent support for industrial intelligence.

Secondly, the pace of technological innovation should be accelerated to enhance the driving force of industrial intelligence to empower urban CEE. The government should establish a sound innovation ecosystem, including research and development centers and incubators to promote close cooperation and knowledge transfer between academia, industry and the government. The government should also strengthen basic and applied research, encourage enterprises to carry out research in areas such as new materials, biotechnology and information technology, optimize the incentive mechanism for innovation and improve the intellectual property protection system, thereby protecting the interests of innovators and encouraging more technological innovation activities.

The Government should clarify the positioning of urban development and industrial layout in accordance with regional characteristics, so as to avoid disorderly competition and duplicative construction in cities. The government should also liberalize market access, attract foreign investment into advanced industries and services, and promote the development of an export-oriented economy. In addition, the Government should foster strategic emerging industries and accelerate the development of industrial digitalization, networking and intelligence.

Fourthly, attention should be paid to the “spatial spillover effect” of industrial intelligence on the urban CEE. Each region should form a synergistic development idea, and synergize the development of infrastructure interconnection and interoperability, data resource opening and sharing, ecological environment joint prevention and joint treatment, and public services universal sharing, etc. Each region should also give full play to its comparative advantages by clarifying the boundaries of the rights and responsibilities of the cooperating parties, improving the docking implementation mechanism, innovating the market-oriented operation mechanism, and strengthening the integration and linkage of the industrial chain, so as to realize the complementary advantages and synergy of industrial intelligence.

7.3 Limitations and future research

This study also has some limitations, which can be improved in some aspects in the future. Firstly, the time period of this study is from 2006 to 2020 due to the data limit. Considering that the COVID-19 epidemic in China lasted for 3 years from the end of 2019 to the end of 2022, and the digital economy was booming during this period, the sample can be expanded in subsequent studies. Secondly, this research mainly focuses on the macro level of the city, and the discussion on the micro level is insufficient. Considering that artificial intelligence has a significant impact on the production activities of enterprises and the consumption habits of the public, it is necessary to combine macro and micro perspectives. Thirdly, this research investigates the influence mechanism of industrial intelligent development on CEE from perspectives of technological innovation and industrial structure optimization, further research needs to explore other economic and social variables that may be the mechanisms by which industry intelligence acts on CEE.

Data availability statement

The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found below: https://www.stats.gov.cn/ .

Author contributions

XX: Conceptualization, Data curation, Formal Analysis, Visualization, Writing–original draft. MC: Conceptualization, Funding acquisition, Project administration, Supervision, Writing–review and editing. AZ: Data curation, Resources, Software, Supervision, Writing–original draft. YW: Data curation, Investigation, Visualization, Writing–review and editing.

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. General Project of Hunan Province 14th Five-Year Plan Education Planning Project (ND227634); Key Project of Hunan Social Science Achievement Evaluation Committee (XSP2023ZDA004); Natural Science Foundation of Hunan Province (2022JJ696).

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Abbreviations

YEB, Yangtze River Economic Belt; CEE, Carbon emission efficiency; IFR, International Federation of Robotics.

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Keywords: industrial intelligence, carbon emission efficiency (CEE), Yangtze River Economic Belt (YEB), the matthew effect, high-quality development

Citation: Xiao X, Chen M, Zhang A and Wu Y (2024) Can industrial intelligence promote carbon emission efficiency? --empirical research based on the Yangtze River Economic Belt. Front. Environ. Sci. 12:1423187. doi: 10.3389/fenvs.2024.1423187

Received: 25 April 2024; Accepted: 17 June 2024; Published: 09 July 2024.

Reviewed by:

Copyright © 2024 Xiao, Chen, Zhang and Wu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Ming Chen, [email protected]

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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• Schizophr Bull
• v.32(1); 2006 Jan

Emerging Empirical Evidence on the Ethics of Schizophrenia Research

Laura b dunn.

2 Department of Psychiatry, University of California, San Diego

Philip J Candilis

3 Department of Psychiatry, University of Massachusetts Medical School

Laura Weiss Roberts

4 Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin

Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics.

Introduction

The personal suffering and public health consequences of schizophrenia create a societal need—many would say an ethical imperative—to perform scientific studies on its etiology, treatment, and prevention. 1–9 The importance of research on schizophrenia is especially great in light of the international burden of the disease. 10–14 Moreover, current treatments, while beneficial, provide only symptomatic relief, may be difficult to tolerate, and often do not restore premorbid levels of functioning. 15–17 In addition, many treatment approaches lack adequate empirical support. 18–21

Although these realities urge further research, the specific nature of this serious illness 22 has raised concerns about the potential vulnerability of research participants with schizophrenia. 5,23–25 For reasons of scientific validity, 26 the research needed to help those diagnosed with schizophrenia must recruit people who are actually affected by the disorder. This, in turn, has raised important questions about the ethical conduct of schizophrenia research. 27–36 Sincere and thoughtful individuals hold different opinions on recruitment strategies, acceptable risks, appropriate safeguards, and other questions, while federal regulatory standards (such as the “Common Rule”) 37 do not offer specific guidance on many controversial issues. 33,38–40 (See Fischer, 40 in this issue, for a comprehensive review of important historical documents in the field of research ethics.) The empirical study of ethical aspects of schizophrenia research has therefore sought to clarify and resolve many of these disagreements. 32,34,41,42

Consequently, schizophrenia research ethics has grown dramatically over the past decade, fueled by the collaborative efforts of multidisciplinary investigators, the receptiveness of editors to publish novel and early developmental work, and most important, the commitment of resources to the study of research ethics by the MacArthur Foundation, the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, the Greenwall Foundation, the Alzheimer's Association, and others. Prominent themes in this revitalized literature include constructive approaches to the ethical dilemmas of certain scientific designs, research participants' strengths and vulnerabilities related to informed consent and decision-making capacity, attitudes toward clinical research and influences on research participation, protocol review, and broader considerations of scientific integrity in mental health research. 5,24,25,43–49 In this article we provide an overview of data-based publications in schizophrenia research ethics and outline possible directions for additional inquiry. It is our hope that this review will help characterize the strengths and gaps in the field, inspiring future inquiry and creating a context for understanding the array of empirical and conceptual manuscripts featured in this special issue of Schizophrenia Bulletin .

Diverse Scientific Designs and Procedures

Diverse study designs are necessary to resolve the varied scientific questions about schizophrenia that remain. Protocols that incorporate placebo comparisons, randomization, “blinding,” and medication-free intervals help to determine the impact of pharmacologic interventions. 50–53 Epidemiological approaches examine the association between putative etiological factors, such as infection and famine, and the later emergence of schizophrenia. 54–57 Symptom provocation helps to examine and model illness-phenomena and their correlates. 58 Studies with people identified as “at risk” for the development of schizophrenia, such as prospective prodromal and genetic studies, help to establish biological and psychosocial vulnerabilities, sources of resilience, and other disease features. 59,60 Such widely differing protocols require varying procedures and combinations of procedures. These may range from gathering and analyzing de-identified data from national databases to withholding medications, administering new pharmacological agents, conducting neuroimaging studies, performing in-depth structured interviews, drawing blood, or providing psychotherapy. 61–65 Other examples exist as well, ranging from large multicenter phase 4 clinical trials to health economics and services studies, each of which differs because of the hypotheses being tested. 66,67

Four predominant ethics issues arise from these designs and procedures. 29,30,68–72 First is the issue of whether novel intervention studies (especially those that are prolonged) compare new medicines with placebo, standard treatments, or “treatment as usual.” 68,73,74 This is a particular concern in studies where standard or usual treatments offer symptomatic improvement but are of uncertain effectiveness because of imperfect prior research. 35 Researchers may consequently turn to placebo controls, finding it difficult to satisfy obligations to research subjects to offer “comparable” treatments, when scientific equipoise on the effectiveness of those treatments has not yet been established. 75–77 The second issue pertains to whether the risks associated with an individual project are appropriate, eg, no single risk is excessive in proportion to the nature of the illness, the risk-benefit ratio is acceptable in light of the aims of the work, and the psychosocial and biological risks are well described. 25,52,78,79 Objections to these kinds of risks are often raised in studies using medication-free intervals or symptom provocation. 29,80,81 The third issue is whether sufficient safeguards protect participants from research risks. 33,78,82 For instance, do research volunteers truly understand the nature of the risks they are undertaking, and do institutional review board (IRB) members perform adequate oversight of more burdensome and nontherapeutic studies? Should capacity be routinely reevaluated during the course of these kinds of studies? 83,84 Finally, are certain designs or procedures unacceptable under all or specific circumstances, perhaps for reasons related to societal values? 69 Although subjects may wish to take on certain risks, do human rights or community concerns trump their decision? 35,85,86

Empirical evidence has helped to address some of these ethical concerns (see Table 1 ). Consider, for example, the ethics of medication-free intervals and placebo comparisons in schizophrenia. Moser and colleagues recently reported on 10 patients whose antipsychotic medications were withdrawn as part of a medication washout phase. 87 Although the patients' reasoning scores did decline, MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding and Appreciation subscale scores remained stable from before medication withdrawal until the 2-week retest (ie, still during the medication-free interval). 87 This study suggests that some participants may retain decisional abilities even when their antipsychotic medication is stopped, although further work is necessary to replicate this small study.

Scientific Designs and Procedures

Note : Abbreviations used: MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research; 146 pts = patients; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.

Roberts et al. have also provided relevant data on medication-free periods in research. 88,89 They asked patients diagnosed with schizophrenia about the level of risk associated with a medication washout, finding that the respondents assigned “moderate risk” to this procedure. This was significantly more than having a physical examination and significantly less than a spinal tap or taking a “dangerous new medication.” 89 In this study, willingness to participate in a protocol was inversely related, and appropriate, to participants' perceptions of study risk. It should be noted, however, that participants were given only brief descriptions of these research procedures (as opposed to a complete study consent form), and their understanding of the procedures was not assessed. Thus, more work is needed to clarify how understanding of procedures, in the context of a study as a whole, may affect perceived risks or willingness to participate.

In an earlier project, Roberts et al. had asked people with schizophrenia and psychiatrists for their views of a hypothetical clinical trial in which a study participant experienced symptom reemergence during a washout. Unexpectedly, the majority of patients and doctors recommended giving the ill study participant medication against his wishes to gain symptomatic relief and recover earlier levels of functioning. 88 This suggested a more paternalistic attitude than might otherwise be expected from these respondents.

Related concerns about medication-free intervals stem from the possibility of lasting harm from symptom reemergence, although there is no conclusive evidence that harm occurs. 90 Meta-analyses of placebo-controlled studies in schizophrenia have not definitively demonstrated an increased risk of suicidality among subjects receiving placebos, 91,92 as once feared. 68 Issues around the exclusion of suicidal patients from clinical trials are explored cogently in the article by Wilson and Stanley (in this issue). 84 Taken together, these findings underscore the need for further empirical work to respond to the concerns of participants, families, communities, clinicians, and investigators.

Similarly, empirical ethics researchers can provide more data for understanding the ethical dimensions of prodromal and first-episode schizophrenia research. 93–96 Corcoran recently provided a comprehensive review of the ethical issues pertinent to prodromal research, 96 highlighting psychosocial risks such as stigmatization and loss of confidentiality. Additionally, the manner in which investigators define the new prodromal entities (see Wilson and Stanley, 84 in this issue) and the ways that subjects weigh the actual risks of early intervention against the potential risk of future illness remain important as well. Variation in rates of “conversion” to psychosis in clinical studies, as discussed in the article by Haroun and colleagues in this issue, 97 further complicates risk and benefit assessments. Empirical work examining the perspectives of first-episode individuals and their families, 93 the risks for noncompliance, and understanding of potential risks and benefits is now being conducted, while others have begun to apply the MacCAT model to capacity assessments among prodromal and first-episode subjects. 98–101

Currently, some of the most rapid progress in psychiatric research comes from studies that examine genetic vulnerability, interactions of genetic and environmental factors on disease expression, the role of endophenotypes, and genetic and genomic determinants of treatment response. 102–110 However, the ethical considerations of these genetic studies have seldom been evaluated using empirical ethics methods. In a unique early study Roberts et al. asked people with schizophrenia their perception of risk associated with a general blood draw versus a blood draw for genetic information. 89 The respondents did not assign greater risk to the genetic test, apparently focusing solely on the minimal biological risk associated with venipuncture. This is another area where empirical ethics can be useful in describing the ethical landscape.

Specific ethical considerations for genetics research endeavors arise from the personal, social, financial, and occupational consequences (intended or not) of the quest for greater genetic information. 111,112 What are the implications for insurability, schooling, and employment? How are people's childbearing decisions affected? How well do people understand the complex information they receive? How much information should be provided, and what are the best educational approaches for providing it? What protections can and should be implemented to protect private information? What are nonenrolled relatives entitled to learn? There is some preliminary evidence on the views of nonschizophrenia populations regarding genetic research, but more work is needed in schizophrenia, just as in other major neuropsychiatric illnesses. 111,113–116

Given the immense potential impact of genetic information, empirical ethicists cannot afford to ignore the personal, familial, societal, and policy aspects of psychiatric genetic and genomic research. 117–119 Although investigators are currently advised not to offer research participants data from their own test results (on the grounds that the data do not meet standards for clinical utility or “reasonable medical certainty”), 120 the time will come when genetic data may be interpretable at an individual or family level. As this point nears, personal and social ethical considerations will become increasingly pressing. 121,122

Evidence regarding other scientific designs and procedures is lacking as well. For instance, very few studies have examined ethical issues related to different phases of multicenter clinical trials, neuroimaging, crossover designs, sequential research projects, and symptom provocation by biological interventions (eg, intravenous agents or disturbing visual images to trigger trauma-related responses and symptoms).

As we seek to understand the ethical issues associated with these designs, it will be important to assess and integrate the views of patient-participants, as well as other stakeholders, like families and clinicians. Early work comparing these perspectives has already yielded interesting and unexpected results. 88,123 Risks associated with different kinds of research and procedures are seen differently by participants, clinicians, and different subject populations. 88,123–125 As highlighted by the large online survey presented in this issue by Muroff and colleagues, 126 psychiatric research may be stigmatized in the eyes of the general public—in particular, the notion that people with psychiatric disorders may lack capacity to consent appeared to drive the more restrictive views of respondents toward psychiatric research compared with research on medical disorders. This important finding should raise awareness among investigators and reviewers, indicating the need to be attuned to ongoing stigma toward psychiatric research.

Finally, a relatively unexplored question concerns how best to perform ethics research itself. 42 Issues such as what sort of threshold for capacity to consent should be required for studies on capacity to consent (see Saks, Palmer, and Dunn, 127 in this issue), the relevance of therapeutic misconception for adequacy of consent (see Miller and Wendler, 42 in this issue), and deception in ethics-related research, for example, require further elucidation. 128

Decision-Making Capacity and Informed Consent

Descriptive studies.

An early and ongoing focus of empirical ethics work has been the assessment of decision-making capacity. It is important to note that, prior to the application of empirical methods to study consent-related abilities of people with psychiatric disorders, a common perception was that people with serious psychiatric disorders, such as schizophrenia and depression, were incompetent to consent to research. 129 In the 1980s and 1990s numerous studies began to examine this view more rigorously. (Although beyond the scope of this article to review these in detail, excellent reviews of these early studies are available. 45,130 ) In addition, investigators began to examine consent procedures themselves, suspecting that difficulties with informed consent resided at least partially in those procedures and not just in characteristics or symptoms of the patients. Intriguing results emerged from these early studies, including findings that (1) many consent forms and disclosures were inadequate, but even with improved disclosures, many patients continued to have difficulty understanding research; 129 (2) many participants in research did not understand randomization and double-blind procedures and seemed to believe that the research was conducted for their personal benefit; 129,131,132 (3) cognitive symptoms, conceptual disorganization, and acute psychosis were related to decision-making abilities; 133–136 and (4) patients with neuropsychiatric disorders showed both heterogeneity, as well as strengths, in informed consent contexts (relating both to research and treatment). 134–139

The highly innovative multiyear, multisite MacArthur competency study, which laid much of the groundwork for inquiry into decisional abilities, was the largest systematic study of capacity to consent. 134–136 It operationalized the concepts of understanding, appreciation, reasoning, and expression of choice into semistructured interview instruments and used them to evaluate decisional abilities of people with schizophrenia or schizoaffective disorder, major depression, ischemic heart disease, and healthy control subjects matched for each diagnostic group (total N = 498). 134–136 The schizophrenia and depression groups manifested worse understanding, appreciation, and reasoning compared with the control groups, and the schizophrenia subjects were more likely to score in the impaired range (defined as a level of performance that would include fewer than 5% of the community controls) compared with the patients with depression and heart disease. 135 Appelbaum et al. have since described the research strengths of subjects with moderate depression, 140 findings supported by Stiles et al. in their work. 141 And as we note below (and see Table 3 ), people with schizophrenia show strong responses to education on the consent process.

Intervention Studies: Informed Consent in Schizophrenia

Note : Abbreviations used: fMRI = functional magnetic resonance imaging; MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research; 146 pts = patients; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.

Nonetheless, a key finding, borne out by subsequent research, was that subjects with schizophrenia showed substantial heterogeneity in their performance, and many (48%) were not impaired on any of the 3 main measures. 135 Furthermore, impairment on one scale was not predictive of impairment on the others, indicating that individuals could vary not just from one another, but also from scale to scale. Finally, test-retest findings indicated that changes in symptoms appeared to relate to changes in decisional abilities, supporting the notion that decisional abilities are not static traits but fluctuate with changes in other important factors. 134

The original instruments were lengthy and, while suited to the important and specific task of characterizing the abilities of these populations, were not subsequently adopted for more than a few other studies. 142,143 Appelbaum and Grisso themselves—the developers of the instruments—emphasized that they were not appropriate or designed for routine clinical use. 144 However, the instruments were later adapted into shorter versions, evolving into the now widely used MacArthur Competence Assessment Tools for Treatment (MacCAT-T) 145 and Clinical Research (MacCAT-CR). 146

The MacArthur study was critical not only for collecting valuable data but also for highlighting the development of shared methods like well-validated assessment instruments. Numerous studies utilizing the MacCAT-T and MacCAT-CR have been conducted to date, many of which are reviewed here (also see Dunn et al. 147 for a review of these and other decision-making assessment tools). As with the assessment of any complex human task, however, it is unlikely that any one tool will be the ultimate authority in evaluating decision-making capacity. Thus, post-MacArthur, the continued development, refinement, and validation of tools for assessing capacity remain important for empirical ethics. 44,147,148

Another focus of evidence-based ethics researchers has been the effect of psychiatric symptoms on decisional abilities, particularly relative to other influences such as cognition. Early work pointed to the mixed role of psychotic symptoms in decisional impairment. For example, before, during, and after MacArthur, 133,135,149 conceptual disorganization (as measured with the Brief Psychiatric Rating Scale 150 ) was found to be correlated with impaired understanding of treatment disclosures among schizophrenia patients. In more recent studies using the MacCAT-CR and other measures of decisional abilities, psychotic symptoms have not been as strongly or consistently associated with decisional abilities as cognitive functioning ( Table 2 ). 148,151–155

Decision-Making Abilities of People With Schizophrenia and Related Disorders

Note : Abbreviations used: AD = Alzheimer disease; BPRS = Brief Psychiatric Rating Scale; DM = diabetes mellitus; MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research; 146 MacCAT-T = MacArthur Competence Assessment Tool for Treatment; MDD = major depressive disorder; PANSS = Positive and Negative Syndrome Scale; pts = patients; SCZ = schizophrenia; WCST = Wisconsin Card-Sorting Task. Unless otherwise specified, “patients” refers to patients with schizophrenia.

Much of the recent research on decision-making capacity addresses whether, when, and to what degree people with serious mental illnesses are able to consent to research. The debate over these questions was fueled in large part by the 1998 report of the National Bioethics Advisory Commission, Research Involving Persons With Mental Disorders That May Affect Decision-Making Capacity . 28 This report, although intended to facilitate additional protections for people with mental disorders, itself became a focus of debate because it did not give adequate weight to what was already known about decisional capacity (ie, the heterogeneity of decision-making capacity among people with mental illness). 5,130,156,157 It also seemed to single out psychiatric illness for special protections, when, in fact, many medical disorders and demographic variables (eg, lower education) appear to place people at greater risk. 156,158,159 The report was never approved by the federal government, in part due to these concerns. Indeed, the growing body of evidence (much of which is cited here) suggests that while people with schizophrenia are more vulnerable to impaired capacity, “psychiatric patients and psychiatric research are fundamentally similar to medical patients and medical research, respectively.” 5 (p1428) Nevertheless, the report represented a watershed event for empirical ethics research in schizophrenia. It invigorated investigators to characterize more comprehensively the decisional abilities of people with psychiatric disorders and to devise and test methods for improving the consent process.

This body of work underscores that people with schizophrenia, while at risk for impairments relative to healthy comparison groups, should not be categorically viewed as having impaired capacity because many perform as well as their non-ill counterparts. This point, as well as the heterogeneity of performance of schizophrenia patients (as evidenced by larger standard deviations on measures of decisional abilities compared with normal comparison groups) is emphasized in the analysis provided in this issue by Jeste, Depp, and Palmer 160 and by Appelbaum's review. 44 As we have noted above, the collected data also indicate that cognitive impairments, rather than psychopathology, may represent the greatest threat to informed decision making. 33,44,151,153,155,161

Areas in need of further study related to decision-making capacity for schizophrenia research are highlighted in several other articles in this issue. 44,162 Kim emphasizes, in a valuable conceptual piece, that translating the accumulated data on decisional abilities into categorical capacity determinations has proved challenging. 162 Nevertheless, he asserts, if the field strives to inform policymaking, then this line of inquiry needs to be vigorously pursued. Given that IRBs are becoming more prone to require capacity assessments and explicit statements and justification from investigators about how capacity will be determined (as Appelbaum points out in this issue), 44 this area of research gains even more practical urgency for investigators. Other areas in need of further exploration include development and validation of brief screening tools for the identification of people at risk of impaired capacity (see, eg, Appelbaum's review in this issue), 44,148 and investigating the ethical aspects, correlates, and complicated implications of other forms of capacity, such as financial capacity (for a thorough review of this neglected ethical topic, see Marson and Phillips, 163 in this issue).

Intervention Studies

Given the findings of early decision-making studies in schizophrenia, an important next effort was to improve subject decision making. This would help optimize abilities to consent to both research and treatment. These studies (summarized in Table 3 ) present an encouraging picture: with thoughtful efforts aimed at providing an educational consent process, most people with schizophrenia can perform adequately on decision-making assessments. In studies using a variety of educational methods, the mean performance of patients rose to the same level as that of healthy comparison subjects. 83,141,151,164

Several unanswered questions remain, however. First, it is still not clear, despite numerous positive studies, what constitutes the active element of these interventions. Is it the method of education or the enriched social interaction that makes the difference in consent enhancement? Most studies did not attempt to control for this possibility (eg, with an enhanced social element in the control condition), nor did they generally report the comparability of time spent in each consent condition. Thus, more emphasis is needed on disentangling various aspects of the consent process.

Moreover, have any of these findings been translated into actual practice? Empirical ethics researchers must take the next step of enhancing real-world research practices. Participation on IRBs, consultation to research review systems, and insistence on the evidence-based standards now available will help assure that the valuable work conducted to date fulfills its promise of improving the ethical foundations of research. Such efforts can enhance the experiences of and protections for the volunteers who make these scientific endeavors possible.

Understanding/Perceptions of Risk and the Therapeutic Misconception

Understanding/perceptions of risk.

All prospective research participants are expected to understand and weigh the risks of a research protocol prior to making their decision. For psychiatry researchers it is consequently important to know whether subjects understand risks adequately, whether they judge risks like nonpsychiatrically ill individuals do, and how these judgments affect their participation. There is a growing body of literature on this topic among people with schizophrenia ( Table 4 ).

Understanding/Perceptions of Research Risks and the Therapeutic Misconception

Note : Abbreviations used: MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research; 146 pts = patients; SAD = schizoaffective disorder; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.

This work suggests several conclusions, as well as the need for further investigation. First, people with schizophrenia have been found to be sensitive to the special risks involved in the controversial designs described earlier. Specifically, they recognize heightened risks associated with washout and medication-free intervals. 88,123 Moreover, patients are able to discern meaningfully among different, hypothetical research protocols of varying levels of potential harm. 123 In that study of decisions about washout and placebo control, patients' ratings of risk frequently differed from those of psychiatrists: patients rated the scenarios as more harmful. Roberts's team also found that willingness to participate was inversely associated with perceptions of research risks. 88,123,165 Similarly, Hummer and colleagues indicate that concerns about potential risks associated with a placebo-controlled trial were a disincentive to participate for over half the patients surveyed. 166

In some cases, efforts to inform participants about the risks of specific protocols appear to need more work. For example, in a relatively low-risk protocol, researchers found that, compared with healthy controls, middle-aged and older patients with schizophrenia had more difficulty responding to an open-ended question about the potential risks of enrolling. 167 In this same study it was found that a computer-based, enhanced consent procedure was associated with better performance on the question. 167

Further studies will be needed to clarify the dimensions of nonbiological risk (eg, psychosocial, economic, anxiety-related) that are associated with taking part in psychosocial or survey research. 47,96,168,169 In biologically oriented research as well, the phenomenon of “respondent burden” (eg, time, energy, and emotional expenditures by participants) has received only passing interest. As defined recently by Ulrich and colleagues, 170 (p17) “respondent burden” can be viewed as “a subjective phenomenon that describes the perception by the subject of the psychological, physical, and/or economic hardships associated with participation in the research process.” Perspectives of patients, family members, clinicians, investigators, and reviewers should be sought on the risks and burdens of existing and emerging forms of research, including “respondent burden.” Other forms of risk that have not been thoroughly elucidated have been dubbed “bystander risk” 86 —namely, the biological and nonbiological risks to nonsubjects. These types of risks have been more commonly described in research on sexually transmitted diseases and genetics, but examples in psychiatric protocols have also been cited. 86 Legal, psychological, and privacy-related risks of research can also accrue to bystanders; more work is needed both conceptually and empirically to clarify the types and impact of these risks and to develop guidelines for investigators and reviewers in analyzing and safeguarding against them.

Therapeutic Misconception

Related to the focus on understanding and perception of research risks is the conceptualization of potential benefit in research. Appelbaum and colleagues have forged an intriguing line of research that seeks to uncover potential misconceptions among both participants and investigators. The foremost of these misconceptions, the inappropriate confusion or conflation of research methods and goals with those of usual clinical care, has been termed “the therapeutic misconception.” 131 This misconception leads to an unrealistic or inappropriate expectation of personal benefit or individualized care. A number of authors in this issue discuss the relevance of the therapeutic misconception to the ethical basis of schizophrenia research. 42,171–173

Since the initial description of the therapeutic misconception in 1982, 131 investigators and commentators have been concerned and puzzled about this problematic—and possibly quite prevalent—aspect of research participation. 174 Although the initial misconception studies involved patients who were participating in psychiatric research, the phenomenon has since been described in many nonpsychiatric research populations. 175–180 The true prevalence and risk factors for therapeutic misconception remain elusive, however, in part because consensus has not yet emerged on what beliefs or statements truly constitute it. 181 Moreover, whether evidence of therapeutic misconception should invalidate informed consent or invoke extra protections also requires clarification. 42,182

Several relevant studies have now been completed, although more work is needed to identify specific vulnerabilities and to develop interventions designed to address them. Ideally, future studies will use shared methods (including validated measures of the therapeutic misconception and its effects), allowing results to be compared meaningfully.

Among those studies already completed, the largest investigated the therapeutic misconception in a wide variety of research protocols. Lidz, Appelbaum, and colleagues 183 employed extensive interviews with 225 subjects enrolling in 44 research trials (ranging from phase 1 cancer chemotherapy trials to other phase 3 and 4 trials). They examined beliefs about research participation, risks and benefits, and differences between research and usual care. Nearly a third of research participants appeared to hold inaccurate beliefs regarding the degree of individualization of their treatment (termed “TM 1 ”). Approximately one-half of participants held unreasonable beliefs regarding the nature or likelihood of benefit (deemed unreasonable based on the specific study in which they were enrolling and called “TM 2 ”). Over 60% of participants manifested a therapeutic misconception judging by one or both of these criteria. 183,184 Older age, lower education, and worse self-described health placed people at risk for holding a therapeutic misconception.

In a study of people with schizophrenia, Dunn and colleagues used a brief, 6-item questionnaire asking about TM 1 -related beliefs within a hypothetical, placebo-controlled, clinical trial. 185 Of 87 patients with schizophrenia or schizoaffective disorder, approximately two-thirds answered at least 1 question incorrectly. However, nearly one-third answered all items correctly, suggesting that many participants are able to distinguish the sometimes subtle differences of research from usual care.

Performance on this particular measure of therapeutic misconception was correlated with MacCAT-CR performance and with neuropsychological functioning, but not with psychopathology. In Candilis and colleagues' report (in this issue), the authors also found that some respondents did not seem to grasp the inherent uncertainty of the scientific method, believing that they would “get a better treatment.” 172 However, differentiating the therapeutic misconception from hope and trust in one's doctor remains an elusive yet necessary aspect of ethics research.

In a semistructured interview study of people with schizophrenia, Roberts et al. have found that respondents consistently indicate that research of varying kinds offers greater benefit “to society” than to individual participants (unpublished data). This suggests that some schizophrenia research volunteers may indeed have an intellectual understanding of the overall goals of research. A cautionary note, however, is that participants in this study erroneously ascribed benefit to individual study volunteers enrolled in “toxicity” studies, indicating that people with schizophrenia may not understand all types of protocols without specific consent processes to support their understanding.

These findings all point to the need, expressed for a number of years, for brief, targeted efforts to address the therapeutic misconception. Educating research participants about key distinctions between research and usual care are essential to these efforts. 132,174 Because these distinctions will depend on the unique characteristics of a given protocol, efforts should be made to develop educational interventions tailored to specific types of studies (eg, pharmacologic, psychosocial, genetic).

Influences on Research Participation

Voluntarism

Informed consent encompasses not only the provision of relevant information and the presence of decision-making capacity but also voluntariness. 186 As articulated in The Belmont Report , voluntariness in research participation “requires conditions free of coercion and undue influence.” 186 Operationalizing these broad requirements has proved more challenging. Compared to the conceptual and empirical work on information disclosure and decision-making capacity, voluntarism has received relatively little attention until recently ( Table 5 ). 187,188

Note : Abbreviations used = MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research; 146 MDD = major depressive disorder; MMSE = Mini-Mental State Examination; PANSS = Positive and Negative Symptoms Scale; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.

Like other concerns about psychiatric research, those related to voluntarism arise from worries about the abilities of people with mental illness to exercise their autonomy. Can subjects identify and enact their genuine preferences in the face of serious symptoms and difficult life circumstances? Some fear that these challenges—though not unique to psychiatric syndromes—may lead to increased vulnerability or perceptions of pressure to participate. These concerns have not been adequately investigated using empirical methods. 187,189,190

Several recent articles have attempted to address this void in more detail. Roberts, for example, offered a conceptual model of voluntarism 189 that employs a positive operationalization. In this view, voluntarism may comprise 4 components—including authenticity based in one's own circumstances, history, clarity, intentionality, and coherence with one's values. Roberts's outline of 4 domains that contribute to voluntarism (developmental; illness-related; psychological, cultural, and religious; and external features and pressures) provides a starting point for inquiry: which elements, for example, affect the decision about whether to participate, and which affect the entire experience of participation?

Nelson and Merz parsed voluntariness slightly differently (although the same fundamental domains articulated by Roberts are apparent in their model). 187,189 Their model describes potential influences on voluntariness arising from the characteristics of research subjects, including capacity, socioeconomic factors, and other role- or illness-related factors. It also details potential researcher- and setting-related factors. These include 3 forms of influence initially described by Faden and Beauchamp, ie, persuasion, manipulation, and coercion. 191 As Nelson and Merz emphasize, our knowledge of the prevalence of any of these influences is limited because of the paucity of research.

In research examining the genetics of psychiatric disorders, voluntarism takes on a previously unstudied dimension—the effect of family and its role. Families can affect participation decisions, ongoing study involvement, and poststudy information sharing. 192 These aspects of voluntarism (which seem to fall into several of the domains outlined by Roberts) have also not been studied adequately. Work in other fields (notably the genetics of breast cancer and Huntington's disease) 193–195 can be informative, but it is not necessarily descriptive of the experience of persons with mental illness.

Motivations for Participation in Research

People with schizophrenia report several positive motivations for their decisions to enroll in research projects. Similar to other research populations, patients with schizophrenia endorse the scientific, social, psychological, and compensation-related benefits of participation. 165,196 A series of semistructured interview studies by Roberts et al. have documented that people with schizophrenia express altruistic attitudes pertaining to research. They seek to help society, to help science, to help others with the illness (now and in the future), and to help foster hope. 196,197 People with schizophrenia cite a number of other factors that influence their reasons for participating in research. 165,196,198–200 For instance, approximately half of a sample of participants with schizophrenia who were interviewed in depth about their motivations cited biological need. 165

Although limited data exist regarding the differences between individuals who do and do not agree to participate in research—in part, because it is difficult to conduct these kinds of studies—the data that do exist tend to support the notion that patients with schizophrenia are fundamentally similar to patients with medical illnesses. 172,198,199,201,202 For example, Candilis and colleagues' novel work on this issue indicates that patients with schizophrenia and schizoaffective disorder provide a combination of socially directed and personally motivated reasons for research participation. Because this hypothetical study related to an antibiotic trial, rather than a trial of antipsychotic medication, it would be interesting to learn more about motivations for participation decisions related specifically to psychiatric trials, particularly as risks escalate.

There is also little data examining the role of financial incentives to participate in research. For years, concerns have been expressed about the potentially coercive effects of monetary payments, although others have tried to allay these concerns. 203–207 Yet the few empirical studies that have been conducted (in nonpsychiatric patients) do not clearly indicate that monetary payments lead potential research subjects to ignore risk. 202,208 Similarly, Candilis et al. found that the role of monetary compensation for a hypothetical antibiotic trial seemed to be minimal for most participants. 172 By contrast, Roberts et al. found that monetary compensation was given greater weight than doctors' and family recommendations by people who were considering hypothetical medication-free and placebo-control schizophrenia protocols. 88,123 These findings point to the need for further study of how potential participants balance various influences. Studying the effects of financial and other types of compensation, in combination with and relative to other potential influences on decision making in actual, not just hypothetical, research contexts, would be particularly valuable. 190

Gaining a better understanding of the motivations and barriers to research participation is valuable for all clinical research. Scientific implications fuel this area of empirical ethics research as well, as enrollment of nonrepresentative samples is a threat to external validity. 26 In view of such concerns, Halpern has proposed a novel method for eliciting the views and preferences of potential enrollees. 209 This method, called “prospective preference assessment,” involves polling potential participants (eligible for a planned trial) prior to the formal recruitment process. Barriers to recruitment could be identified and the design modified if indicated. Differences between those who would or would not enroll could also be assessed. This strategy, which can be adapted to schizophrenia research, could easily be evaluated for its effect on efficiency of recruitment and enrollment and on the composition of resulting participant pools.

Key Safeguards: Protocol Review and Participant Advocates

Human research employs many safeguards, some of which—like informed consent, conflict of interest management, confidentiality protections, and institutional review board oversight—are federally regulated. Others—like scientific review processes, debriefing methods, and publication processes—are not. Most of these topics, with the exception of informed consent, have received relatively little attention in empirical studies. As a result, little is known; much remains to be explored. Protocol review by IRBs, ongoing protocol monitoring, and participant debriefing are less scrutinized dimensions of schizophrenia research ( Table 6 ). Because these have a strong influence on the design and conduct of protocols, it is problematic that we do not know more about how they occur and how they affect the research experiences of participants. (The commentary provided in this issue by Shore reflects the need for greater exploration of such issues as participant debriefing, the use of sliding scale risk-benefit assessments, and the use of consent monitors. 173 )

Participant Safeguards

Note : Abbreviations used: CATIE = Clinical Antipsychotic Trials of Intervention Effectiveness; IRB = institutional review board; NIMH = National Institute of Mental Health; PI = principal investigator; pts = patients; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.

The IRB review process, while critical to any study, is itself not well understood or characterized. Only a few studies have been conducted examining the work of IRBs, with most data coming from general descriptions of IRB members or analysis of consent forms and applications. 210–212 Data on the risk-benefit assessments or other review criteria used by IRB members are far less plentiful. 213,214 Despite the ongoing discussions about risk, and the need to protect potentially “vulnerable” groups, minimal data exist about how IRBs actually arrive at their complex decisions. 215,216 IRBs take on the extraordinary challenge of reviewing myriad protocols involving patients with medical and neuropsychiatric disorders, yet there is almost no guidance about how to define terms such as “vulnerability,” 33 how to determine whether investigators have provided protections adequate to the risks of a study, and how to identify adequate group decision making.

Recently, Shah and colleagues at the National Institutes of Health Department of Clinical Bioethics identified variable risk assessments among IRB chairs reviewing pediatric protocols—assessments whose interpretation of risk often ran counter to “available data on risks and [federal] regulations themselves.” 217 (p476) Others have described the variability among IRBs when they assess the benefits of clinical research. 218

For psychiatry in particular, there are many unanswered questions: how do review board members assess risks of psychiatric protocols as opposed to those from other specialties? What factors (eg, protocol-related, reviewer-related, investigator-related) influence the process and outcome of these reviews? Does the review process itself differ for psychiatric and nonpsychiatric protocols, and if so, in what ways? Does variability in interpretation of federal standards affect the assignment of protections to psychiatric subjects?

A large landmark survey of IRB members, chairs, and investigators at 491 IRBs did not explicitly examine differences in level or effectiveness of oversight among different types of protocols (eg, for psychiatric versus medical protocols). The findings, published in 1998 and known as the Bell Report, 210 suggested that overall, those involved in the system of IRB oversight felt it was functioning efficiently and protecting participants' welfare. On the other hand, several urgent findings, as well as recommendations made by the Office of the Inspector General that same year, 219 have yet to be adequately resolved. 220

For example, the Bell survey found notable differences between high-volume and low-volume IRBs in workload and time spent reviewing protocols. 210 It would be useful to examine what influence such differences have on the review process at different institutions. It also appeared that IRBs focused heavily on consent forms, with 60% of chairs reporting that the most frequent concern about consent forms had to do with overly technical language. Despite this finding and recent work confirming ongoing problems with consent form language, 221 meaningful modifications to promote better comprehension have yet to be adopted. In schizophrenia research specifically, we know little about the internal workings of the review and monitoring process for these protocols relative to others.

As noted above, evidence from the pediatric literature suggests substantial variability in how IRBs interpret the language of federal regulations. 37 In Shah et al.'s survey of IRB chairs, for example, investigators found that a lumbar puncture received lower mean risk ratings when the research subject was ill rather than healthy. 217 Thus, it is possible that some reviewers vary the “minimal risk” standard depending on the health status of the subject. In contrast, some commentators suggest that the definition of minimal risk should be measured against risks ordinarily encountered by healthy persons. 222

In psychiatric research, data on differential risk assessment is available from a recent study by Roberts and colleagues. The authors examined psychiatrists' and schizophrenia patients' perceptions of the level of risk of a number of research procedures. Each procedure was described separately, not as part of an overall study, so that procedures could be compared to one another (Roberts et al., in press). 89 Participants rated the risks relative to everyday risks encountered by people with schizophrenia.

Psychiatrists and patients rated many of the procedures as having similar levels of risk, but patients rated several scenarios (eg, symptom induction, lumbar puncture, and 2-week medication discontinuation) as more risky than psychiatrists. These findings raise several points in need of further study: patients may be more attuned to risk than they are often given credit for. Conversely, researchers and review board members may rate risks differently from their subjects. Might this difference have significant effects on the protections required for psychiatric research? Without more extensive data, subjects, communities, and reviewers will not be able to conduct consistent review or construct coherent policy. 130,223

Another safeguard, the use of subject or participant advocates, has only recently been studied empirically (see Stroup, Bredthauer, and Appelbaum, 224 in this issue). This process is designed to safeguard participants who may lack decisional capacity during enrollment in a clinical trial, or who may subsequently lose capacity. In its recommendations the National Bioethics Advisory Commission (NBAC) relied on the use of an ill-defined “legally authorized representative (LAR)” for consent to certain procedures (ie, minimal risk or greater than minimal risk with the prospect of direct benefit). But NBAC would only allow an LAR to enroll an incapable subject if the subject had previously provided authorization. This would require an uncommon degree of prescience on the part of patients and investigators. Leaving aside for the moment the difficulties of determining “minimal” risk and the “prospect” of direct medical benefit, the use of the subject advocate contains many layers of subtlety that have been insufficiently studied, from the standards of capacity assessment to the timing and procedures of surrogate involvement. The work of Stroup and colleagues is therefore highly informative, as it is the first empirical study of subject advocate procedures actually enacted for schizophrenia research.

Although it is not possible to touch on every conceivable area of research ethics in schizophrenia, we have attempted to survey the landscape of recent and emerging findings. Built on the foundation of early studies conducted by pioneers in empirical ethics (whose work is well represented in this issue of Schizophrenia Bulletin ), 42,44,84,163 recent conceptual and empirical work has begun to tackle important questions. These endeavors include exploring the dimensional and categorical aspects of decision-making capacity, detailing the correlates of decision-making capacity, making inroads into enhancing informed consent procedures, bringing forth the previously unheard voices and perspectives of patient-participants themselves, and highlighting the varied needs of participants, families, and their communities.

As schizophrenia research expands and advances in new directions—many of which will bring novel and unexpected ethical challenges—the diverse and vital field of empirical ethics can only improve the collaboration between patients, communities, and researchers. As Table 7 highlights, much remains to be done. We hope that this review informs and stimulates the discussion and future work needed to advance the field.

Ethical Issues in Schizophrenia Research: Research Agenda

Acknowledgments

The authors gratefully acknowledge the National Institute of Mental Health for support for Drs. Dunn (MH66062), Roberts (MH01918), and Candilis (MH01851). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute of Mental Health. Dr. Dunn also wishes to thank the National Association for Research on Schizophrenia and Depression and the Greenwall Foundation for their support. Dr. Roberts also wishes to express her appreciation to the National Association for Research on Schizophrenia and Depression and the National Institute on Drug Abuse. The authors wish to thank Ms. Deannah Neal and Ms. Krisy Edenharder for their technical assistance with this manuscript.

Health | State health department changes research…

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Health | State health department changes research policies at Spring Grove psych hospital

Garrett had started experiencing distressing delusions during his freshman year at Johns Hopkins University. He’d come to his mother, Kristan Kanyuch, holding his head and crying because he thought his neighbors were using telepathic powers to give him a stroke.

He was able to get treatment through an inpatient study at the National Institute of Mental Health — where his mom picked him up to take him to the museum — but he was scheduled to be discharged soon. And it seemed like Kanyuch had suddenly become a trigger for the paranoia caused by his illness.

Kanyuch was panicked. She didn’t have the money to send him to a private hospital, since she had quit her job to take care of him. He couldn’t come home to Harford County, where he could be a danger to Kanyuch and his little sister. She feared homelessness was his only option.

Instead, she was able to get her son a bed in the Treatment Research Unit at Spring Grove Hospital Center — a state psychiatric hospital in Catonsville, where Garrett started taking clozapine, an under-prescribed drug used to treat people with treatment-resistant schizophrenia. Fifteen years later, Garrett is still on clozapine, something he credits, along with the unit, with saving his life.

But the unit’s future is uncertain. The Maryland Department of Health plans to terminate the agreement that created it, health department spokesman David McCallister said Friday in an email.

The health department opened the unit in 1989 with the help of the University of Maryland, Baltimore. Officials involved in its creation had two main goals: providing “state-of-the-art” clinical care to people with treatment-resistant schizophrenia, a population that constitutes about a third of those with the illness, and researching treatments to help them manage their symptoms.

That 35-year-old arrangement is now outdated, McCallister wrote, though he added that its termination would not affect patients or employees at Spring Grove. The unit will continue providing clinical care to patients, though it will no longer be a specialized research unit.

The state’s decision follows months of tumult at the Maryland Psychiatric Research Center — a program under the University of Maryland School of Medicine that oversees research on the Treatment Research Unit. In March, the health department told the center to temporarily stop enrolling inpatients in studies while it reviewed the center’s research protocol.

While health department spokesman Chase Cook said the pause allowed officials to determine “future steps” for enrolling patients who arrived at the hospital through a court order, some mental health advocates were confused by it. They expressed concern in interviews with The Baltimore Sun and in letters to the health department that it would restrict care options for patients and deny them autonomy to make informed decisions about treatment.

“It is imperative that we continue to advocate for the rights of patients to access innovative treatments and participate in research studies that have the potential to transform lives,” Dr. Theodora Balis, president of the Maryland Psychiatric Society, wrote in a May letter to the health secretary, Dr. Laura Herrera Scott. “Patients have the right to choose their course of treatment. The denial of the choice to participate in a research study denies them this choice.”

In an email, Deanna Kelly, the research center’s acting director and director of its treatment research program, said that to her knowledge, there’s never been a complaint from patients, families or physicians about the unit in the three decades it has existed.

For the last three months, Kelly said, only the 17 patients enrolled in the two inpatient studies the center was running before the pause began could participate in such research.

One study funded through the UMB Foundation  examined the benefits schizophrenia patients may experience from eating a ketogenic diet. That’s a high-fat, low-carb plan that some evidence shows may help with the symptoms of severe mental health conditions. The other is a multisite study — funded by the National Institute of Mental Health — that looks at the efficacy of clozapine in reducing violent and aggressive behavior in people with schizophrenia.

Kelly received a letter Tuesday from the Spring Grove Research Committee, saying she could resume enrolling patients in the clozapine study, but not the keto diet study.

That’s because the health department is moving forward only with federally funded studies at department-run institutions, McCallister said. The new rule only affects studies with direct patient contact, he said.

Deborah Kotz, a spokeswoman for the University of Maryland School of Medicine, said the university learned June 21 of the new policy. During the pause on enrollment, Kotz said, the university cooperated with state officials, providing them with information on the research protocol, federal regulations and ethical conduct of the research, which is overseen by the university’s Accredited Human Research Protections Program.

“UMB researchers continue to uphold the highest standards of research procedures to advance science, and we remain hopeful that future negotiations and collaborations will allow us to revisit opportunities for research supported by funding beyond the federal government,” she said.

The letter Kelly received from the hospital research committee told her she could continue the keto study until July 24. However, the patients enrolled have finished participating, she said.

She worries the new policy could hinder future research on schizophrenia in Maryland. Between 2017 and 2022, the National Institute of Mental Health funded only one drug trial for the illness, despite it affecting about 3.8 million Americans and having an economic burden of $343 billion in 2019, according to a 2023 analysis of the institute’s research portfolio . The federal agency also funded 100 fewer research grants for schizophrenia in 2021, compared with 2016, according to the analysis.

Protecting participants

The patient population at Spring Grove today looks different from the one Garrett joined about 15 years ago when he was admitted. Most of the patients at the psychiatric hospital of nearly 400 beds are charged with a crime, but determined by a judge to be “incompetent to stand trial.” That means they didn’t have the mental capacity to participate in legal proceedings at the time of the judge’s ruling.

Unlike patients at the maximum-security forensic psychiatric Clifton T. Perkins Hospital in Jessup, Spring Grove patients are typically charged with minor offenses, such as trespassing, loitering and theft under $100, Kelly said. They’re a vulnerable group of people, who often have a history of homelessness and untreated or treatment-resistant mental illnesses. Roughly 70% are Black. Many are from economically disadvantaged families or have fallen from higher socioeconomic levels due to illness or drug use.

Someone can be incompetent to stand trial and be able to make medical decisions, Kelly said. Figuring out whether a patient has the capacity to consent to participate in the center’s research includes a thorough evaluation, conducted by a researcher and observed by at least one other staff member. The patient is asked to explain a study’s procedures and risks, how they can end their participation, and how to report any discomfort or adverse side effects, as well as other questions.

It’s a misconception that people with schizophrenia can’t make good decisions for themselves, said Dr. Fred Jaskog, research director at the North Carolina Psychiatric Research Center, a program under the University of North Carolina School of Medicine. The center is also participating in the clozapine study.

“You can hear voices, you can have auditory hallucinations, you can be paranoid,” he said, “and you can still step back and say, ‘I understand these symptoms are the way they are and they’re part of my illness. But I also understand that here is this treatment that you’re recommending, and it has these side effects and it can have these potential benefits.’”

Since court-ordered patients at Spring Grove are considered “prisoners” under federal research laws, they have more protections than most study participants, Kelly said. For instance, all inpatient studies must have the potential to provide direct benefits to the patients. Patients also must undergo a lengthy informed consent process, designed to ensure they’re not being coerced. And if a judge has determined that a patient can’t make medical decisions, they’re ineligible.

Researchers don’t recruit patients for studies, Kelly said. They’re considered for participation only if they get referred by one of their doctors or they volunteer.

Additionally, several committees — including the hospital research committee and multiple institutional review boards — keep close tabs on the research. Dr. Charles Richardson, who was the Treatment Research Unit’s director from 1994 until his retirement in 2021, chairs the data safety monitoring board charged with periodically reviewing data collected by center researchers for patient safety. Inpatient studies run by the center are incredibly low-risk, he said. It’s rare for them to report any serious side effects experienced by participants.

“It’s not as if they’re cowboys without oversight,” he said.

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