Negative Symptoms in SchizophreniaNCT06127004
Metacognitive Training for Negative Symptoms
A study testing Metacognitive Training for Negative Symptoms (MCT) and Supportive Counselling in people with Negative Symptoms in Schizophrenia, run by Sormland County Council, Sweden at 1 site in Sweden.
Trial summary
There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Negative Symptoms in Schizophrenia
- What is being tested?
- Metacognitive Training for Negative Symptoms (MCT) and Supportive Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis
- Resident in Region Sörmland, Region Västmanland or Region Uppland
Who cannot join
- Evidence of severe organic brain dysfunction
- Learning disabilities
- Difficulty with the Swedish language
- Visual and/or hearing impairment
- Being unable or unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Simon Cervenka, Prof contact
Sweden1 site, 1 recruiting
- Recruiting
Region Sörmland
Multiple Locations
Linda Swanson, Dr, 0046-72084 3708, linda.swanson@regionsormland.se
About this study
Official title: Metacognitive Training for Negative Symptoms (MCT Minus)
There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. This is reflected in the NIMH-MATRICS consensus statement that emphasised that persistent negative symptoms represent an unmet therapeutic need for patients suffering from schizophrenia.
The purpose of this study is to evaluate, in a scientific manner, the intervention developed by Swanson et al. 2021: Metacognitive Training (MCT) Minus. The MCT was adapted to target negative symptoms in psychotic disorders (e.g. schizophrenia, schizoaffective or non-affective functional psychosis) as the original version of the intervention focused exclusively on positive symptoms. The specific aim is to study whether MCT Minus is a promising treatment for the intended population in terms of reductions in negative symptoms, severity of defeatist attitudes, internalised stigma, and depression as well as improvements in reflective ability and overall functioning.
The research will add to existing research by identifying and measuring potential mechanisms of change for negative symptoms (i.e., defeatist attitudes, reflective functioning, stigma and depression). It will also add to the existing evidence base by measuring whether the cognitive biases addressed in MCT lead to changes in the wider conceptualisation of metacognition used elsewhere and whether the promising results seen in the feasibility study of MCT Minus can be replicated in a randomised controlled trial (RCT) with a control group and a blinded assessor. The researchers also hope to replicate the findings of a previous study, where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity.
Read the detailed description
Introduction:
While clinicians tend to focus on positive symptoms as primary treatment targets in schizophrenia, patients prioritize the treatment of depressive and negative symptoms. Persistent negative symptoms are experienced by approximately 20%-40% of individuals diagnosed with schizophrenia. Current research indicates that negative symptoms are independent from positive symptoms, depression, cognitive dysfunctions, and disorganization. However, neither medication nor existing psychosocial interventions have proven to be efficacious in reducing negative symptoms. Consequently, authors have highlighted the need for better understanding of treatment mechanisms underpinning psychological interventions that directly target negative symptoms.
Psychological conceptualizations suggest that negative symptom expression can, in some cases, be understood as a response to adverse experiences. For example, Beck et al.'s cognitive model suggests that negative symptoms emerge from a process where individuals adopt coping strategies of 'shutting down' the cognitive-affective experience. This allows individuals to cope with overwhelming or aversive situations in the short term but leads to a reliance on negative symptoms (including social withdrawal, avolition, and diminished expression) to reduce exposure to, and impact of, negative experiences in the longer term. From an attachment framework, Griffiths and McLeod (2019) suggest that negative symptoms may be seen 'as responses involving emotional and social withdrawal that emerge from threats to self-security'. If negative symptoms can be understood within cognitive and developmental frameworks, it may be possible to develop theoretically driven interventions for their treatment.
A cognitive model of negative symptoms:
Negative symptoms are associated with low expectations of future success, asocial beliefs, a reduced sense of self-efficacy, negative self-concepts, defeatist performance beliefs and self-stigma. The cognitive model therefore proposes that negative symptoms might be caused and maintained by dysfunctional beliefs arising as a consequence of repeated failures and setbacks. These appraisals might include negative beliefs about social affiliations; low expectations of pleasure, success and acceptance; defeatist beliefs about performance; and a perception of limited resources. The self-perception, and perceived self-efficacy, of individuals diagnosed with schizophrenia may also be influenced by self-stigmatizing views of their mental illness. It might be that these factors result in hypervigilance to perceived criticism. Longitudinal studies have shown support for the cognitive model as defeatist performance attitudes and asocial beliefs are found to predict future negative symptoms.
Metacognition and psychosis:
Metacognition was initially referred to as the capacity to think about and monitor one's mental processes. However, the definition has broadened in contemporary research, ranging 'from discrete processes involving noticing specific thoughts and feelings to more synthetic acts in which information is integrated into complex representations of the self and others'. This has given rise to interventions targeting metacognitive processes, some of which have been specifically developed for psychosis e.g., metacognitive training (MCT); metacognitive reflection and insight therapy (MERIT), while others have been modified for this population. MCT is based on the premise that cognitive biases play a role in the development and maintenance of psychotic symptoms which can be alleviated by targeting underlying cognitive processes. The aims are to gain insight and to learn practical strategies to manage distressing symptoms. MCT has been shown to reduce delusions and positive symptoms and improve cognitive insight and biases. Preliminary evidence also suggests effects on quality of life and illness insight.
Several authors highlight the links between negative symptoms and compromised capacity for self/others mental state processing. There is evidence that suggests a link between metacognition and negative symptoms as limitations in complex metacognitive processes predict negative symptoms in first episode psychosis and in more chronic samples, even after controlling for defeatist beliefs, affect recognition and neurocognitive functioning. Metacognitive deficits are also associated with concurrent and future negative symptoms when controlling for verbal memory and education. Interestingly, self-reflection in itself has been found to mediate the relationship between neurocognition and negative symptoms (especially for deficits in capacity to communicate about internal states, so called diminished expression) while interpersonal cognitive differentiation (i.e., the ability to construe one's experiences as either similar or different from others' experiences) has been found to mediate the pathway between self-reflectivity and negative symptoms. This suggests that negative symptom reduction may at least partially depend on improved metacognitive capacity and that a metacognitive intervention specifically targeting negative symptoms may be beneficial.
Swanson et al. (2021) therefore adapted MCT for negative symptoms to assess the acceptability and feasibility of the intervention, examine variable change over the course of the intervention and carry out a preliminary investigation of putative mechanisms of change. The current project is a further evaluation of this, where the researchers hope to achieve similarly encouraging results in a randomised controlled trial (RCT) with a control group and blinding. The researchers also hope to replicate the findings of a previous study where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity. Importantly, it was found that high network homogeneity levels at baseline in the bilateral superior medial prefrontal cortex could predict symptomatic improvement after 8 weeks of drug plus psychotherapy treatment; this illustrates that a more developed understanding of the biological mechanisms underlying negative symptoms would allow us to identify patients that would benefit from each type of treatment and, through that, change the prognosis and treatment outcomes of the condition.
Significance and scientific novelty:
Research funding has been given for a RCT to evaluate the intervention trialled by Swanson et al, 2021 in a more rigorous and scientific manner. Given our limited understanding of negative symptoms and how to treat them, the study would be of both significance and scientific novelty. To fully understand the biological mechanisms behind negative symptoms is essential to be able to develop future treatment options and to identify patients that would benefit from each type of treatment. A more thorough understanding of schizophrenia would decrease the heterogeneity of the condition which would have vast implications for how individuals diagnosed with schizophrenia are treated both in society and in the healthcare setting.
Previous results:
Two articles (which were based on the main researcher's doctoral thesis at Edinburgh University with funding from National Health Service (NHS) Lothian) have been published in Clinical Psychology and Psychotherapy.
- Conditions
- Negative Symptoms in Schizophrenia
- Being tested
- Metacognitive Training for Negative Symptoms (MCT), Supportive Counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training for Negative Symptoms (MCT)Other
See arm/group descriptions
Supportive CounsellingOther
Se arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Training for Negative Symptoms | Experimental | The original MCT intervention was adapted to negative symptoms by incorporating psychoeducation and strategies to target the cognitions suggested by the cognitive model (Beck et al., 2009) to be implicated in the development and/or maintenance of negative symptoms. Although some of the strategies have traditionally been used to target positive symptoms, it is assumed that the same reasoning styles lead to negative symptoms through the dysfunctional cognitions discussed previously (e.g., jumping to conclusions in regard to social rejection and a dysfunctional attribution style reinforcing social withdrawal). Metacognitive training for negative symptoms consists of eight sessions, delivered individually as there is evidence indicating that this approach may lead to stronger effect sizes than delivery in a group format (Liu et al., 2018). The developer of MCT (Professor Steffen Moritz) approved the modification. Receives: Other: Metacognitive Training for Negative Symptoms (MCT) |
| Control group | Active comparator | Supportive Counselling (8 sessions) will be used as a control. Participants enrolled in this condition can then get the intervention if they request this. Receives: Other: Supportive Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinical Assessment Interview for Negative Symptoms (CAINS) (Forbes et al., 2011)
Clincial interview to assess negative symptoms.
Minimum value is 0 = better outcome. Maximum value is 52 = worse outcome.
Measured: 15 minutes
The Motivation and Pleasure Scale- Self-Report (MAP-SR) (Llerena et al., 2013)
Self-rated questionnaire to assess negative symptoms
Minimum value is 0 = better outcome. Maximum value is 90 = worse outcome.
Measured: 5 minutes
The Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987)
Clinical interview to assess negative symptoms (analysed with the five factor-model)
Minimum value is 0 = better outcome. Maximum value is 210 = worse outcome.
Measured: 20 minutes
Secondary outcomes (5)
The Dysfunctional Attitudes Scale (DAS) (Weissman & Beck, 1978)
Self-rated questionnaire to assess defeatist attitudes
Minimum value is 100 = better outcome. Maximum value is 700 = worse outcome.
Measured: 5 minutes
The Reflective Functioning Questionnaire (RFQ-8) (Fonagy et al., 2016)
Self-rated questionnaire to assess metacognitive ability
Minimum value is 8 = worse outcome. Maximum value is 24 = better outcome.
Measured: 5 minutes
The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) (Hammer & Toland, 2017)
Self-rated questionnaire to assess stigma
Minimum value is 1 = better outcome. Maximum value is 4 = worse outcome.
Measured: 5 minutes
The Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington, & Schissel, 1990)
Clinical interview to assess depressive symptoms in schizophrenia
Minimum value is 0 = better outcome. Maximum value is 36 = worse outcome.
Measured: 10 minutes
The World Health Organization (WHO) Disability Assessment Schedule (WHODAS) 2.0 (WHO, 2010)
Clinical interview to assess overall functioning
Minimum value is 0 = better outcome. Maximum value is 144 = worse outcome.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Negative Symptoms in SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden, Västmanland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Linda Swanson, Dr, Principal investigator, Region Sörmland/ Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127004
- Sponsor's protocol ID
- Region Sörmland
- Other IDs
- Department of Medical Sciences
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on request with other researchers
Publications
Addington D, Addington J, Schissel B. A depression rating scale for schizophrenics. Schizophr Res. 1990 Jul-Aug;3(4):247-51. doi: 10.1016/0920-9964(90)90005-r.
PubMed 2278986Aleman A, Lincoln TM, Bruggeman R, Melle I, Arends J, Arango C, Knegtering H. Treatment of negative symptoms: Where do we stand, and where do we go? Schizophr Res. 2017 Aug;186:55-62. doi: 10.1016/j.schres.2016.05.015. Epub 2016 Jun 9.
PubMed 27293137American Psychiatric Association (APA). (1987). Diagnostic and statistical manual of mental disorders (3rd edition, revised) (DSM-III-TR). APA.
Austin, S. F., Lysaker, P. H., Jansen, J. E., Trauelsen, A. M., Nielsen, H.-G. L., Pedersen, M. B., Haahr, U. H., & Simonsen, E. (2019). Metacognitive capacity and negative symptoms in first episode psychosis: Evidence of a prospective relationship over a 3-year follow-up. Journal of Experimental Psychopathology, 10(1). doi: 10.1177/2043808718821572
Beck, A. T., Rector, N. A., Stolar, N., & Grant, P. (2009). Schizophrenia: cognitive theory, research and therapy. Guilford Press.
Beck AT, Himelstein R, Grant PM. In and out of schizophrenia: Activation and deactivation of the negative and positive schemas. Schizophr Res. 2019 Jan;203:55-61. doi: 10.1016/j.schres.2017.10.046. Epub 2017 Nov 21.
PubMed 29169775Bentall, R. P., Simpson, P. W., Lee, D. A., Williams, S., Elves, S., Brabbins, C., & Morrison, A. P. (2010). Motivation and avolition in schizophrenia patients: The role of self-efficacy. Psychosis, 2(1), 12-22. doi: 10.1080/17522430903505966
Birules I, Lopez-Carrilero R, Cuadras D, Pousa E, Barrigon ML, Barajas A, Lorente-Rovira E, Gonzalez-Higueras F, Grasa E, Ruiz-Delgado I, Cid J, de Apraiz A, Montserrat R, Pelaez T, Moritz S, The Spanish Metacognition Study Group, Ochoa S. Cognitive Insight in First-Episode Psychosis: Changes during Metacognitive Training. J Pers Med. 2020 Nov 27;10(4):253. doi: 10.3390/jpm10040253.
PubMed 33260823Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. doi: 10.1191/1478088706qp063oa
Campellone TR, Sanchez AH, Kring AM. Defeatist Performance Beliefs, Negative Symptoms, and Functional Outcome in Schizophrenia: A Meta-analytic Review. Schizophr Bull. 2016 Nov;42(6):1343-1352. doi: 10.1093/schbul/sbw026. Epub 2016 Mar 15.
PubMed 26980144Correll CU, Schooler NR. Negative Symptoms in Schizophrenia: A Review and Clinical Guide for Recognition, Assessment, and Treatment. Neuropsychiatr Dis Treat. 2020 Feb 21;16:519-534. doi: 10.2147/NDT.S225643. eCollection 2020.
PubMed 32110026Cox C, Jolley S, Johns L. Understanding and treating amotivation in people with psychosis: An experimental study of the role of guided imagery. Psychiatry Res. 2016 Dec 30;246:387-391. doi: 10.1016/j.psychres.2016.09.047. Epub 2016 Sep 28.
PubMed 27788457Faith LA, Lecomte T, Corbiere M, Francoeur A, Hache-Labelle C, Lysaker PH. Metacognition Is Uniquely Related to Concurrent and Prospective Assessments of Negative Symptoms Independent of Verbal Memory in Serious Mental Illness. J Nerv Ment Dis. 2020 Nov;208(11):837-842. doi: 10.1097/NMD.0000000000001219.
PubMed 32740145Flavell, J. H. (1979). Metacognition and cognitive monitoring: A new area of cognitive-developmental inquiry. American Psychologist, 34(10), 906-911. doi: 10.1037/0003-066X.34.10.906
Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
PubMed 27392018
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Training for Negative Symptoms (MCT Minus)
- ClinicalTrials.gov ID
- NCT06127004
- Acronym / sponsor ID
- Region Sörmland
- Conditions
- Negative Symptoms in Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden, Västmanland County Council, Sweden
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. This is reflected in the NIMH-MATRICS consensus statement that emphasised that persistent negative symptoms represent an unmet therapeutic need for patients suffering from schizophrenia.
The purpose of this study is to evaluate, in a scientific manner, the intervention developed by Swanson et al. 2021: Metacognitive Training (MCT) Minus. The MCT was adapted to target negative symptoms in psychotic disorders (e.g. schizophrenia, schizoaffective or non-affective functional psychosis) as the original version of the intervention focused exclusively on positive symptoms. The specific aim is to study whether MCT Minus is a promising treatment for the intended population in terms of reductions in negative symptoms, severity of defeatist attitudes, internalised stigma, and depression as well as improvements in reflective ability and overall functioning.
The research will add to existing research by identifying and measuring potential mechanisms of change for negative symptoms (i.e., defeatist attitudes, reflective functioning, stigma and depression). It will also add to the existing evidence base by measuring whether the cognitive biases addressed in MCT lead to changes in the wider conceptualisation of metacognition used elsewhere and whether the promising results seen in the feasibility study of MCT Minus can be replicated in a randomised controlled trial (RCT) with a control group and a blinded assessor. The researchers also hope to replicate the findings of a previous study, where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity.
Detailed description
Introduction:
While clinicians tend to focus on positive symptoms as primary treatment targets in schizophrenia, patients prioritize the treatment of depressive and negative symptoms. Persistent negative symptoms are experienced by approximately 20%-40% of individuals diagnosed with schizophrenia. Current research indicates that negative symptoms are independent from positive symptoms, depression, cognitive dysfunctions, and disorganization. However, neither medication nor existing psychosocial interventions have proven to be efficacious in reducing negative symptoms. Consequently, authors have highlighted the need for better understanding of treatment mechanisms underpinning psychological interventions that directly target negative symptoms.
Psychological conceptualizations suggest that negative symptom expression can, in some cases, be understood as a response to adverse experiences. For example, Beck et al.'s cognitive model suggests that negative symptoms emerge from a process where individuals adopt coping strategies of 'shutting down' the cognitive-affective experience. This allows individuals to cope with overwhelming or aversive situations in the short term but leads to a reliance on negative symptoms (including social withdrawal, avolition, and diminished expression) to reduce exposure to, and impact of, negative experiences in the longer term. From an attachment framework, Griffiths and McLeod (2019) suggest that negative symptoms may be seen 'as responses involving emotional and social withdrawal that emerge from threats to self-security'. If negative symptoms can be understood within cognitive and developmental frameworks, it may be possible to develop theoretically driven interventions for their treatment.
A cognitive model of negative symptoms:
Negative symptoms are associated with low expectations of future success, asocial beliefs, a reduced sense of self-efficacy, negative self-concepts, defeatist performance beliefs and self-stigma. The cognitive model therefore proposes that negative symptoms might be caused and maintained by dysfunctional beliefs arising as a consequence of repeated failures and setbacks. These appraisals might include negative beliefs about social affiliations; low expectations of pleasure, success and acceptance; defeatist beliefs about performance; and a perception of limited resources. The self-perception, and perceived self-efficacy, of individuals diagnosed with schizophrenia may also be influenced by self-stigmatizing views of their mental illness. It might be that these factors result in hypervigilance to perceived criticism. Longitudinal studies have shown support for the cognitive model as defeatist performance attitudes and asocial beliefs are found to predict future negative symptoms.
Metacognition and psychosis:
Metacognition was initially referred to as the capacity to think about and monitor one's mental processes. However, the definition has broadened in contemporary research, ranging 'from discrete processes involving noticing specific thoughts and feelings to more synthetic acts in which information is integrated into complex representations of the self and others'. This has given rise to interventions targeting metacognitive processes, some of which have been specifically developed for psychosis e.g., metacognitive training (MCT); metacognitive reflection and insight therapy (MERIT), while others have been modified for this population. MCT is based on the premise that cognitive biases play a role in the development and maintenance of psychotic symptoms which can be alleviated by targeting underlying cognitive processes. The aims are to gain insight and to learn practical strategies to manage distressing symptoms. MCT has been shown to reduce delusions and positive symptoms and improve cognitive insight and biases. Preliminary evidence also suggests effects on quality of life and illness insight.
Several authors highlight the links between negative symptoms and compromised capacity for self/others mental state processing. There is evidence that suggests a link between metacognition and negative symptoms as limitations in complex metacognitive processes predict negative symptoms in first episode psychosis and in more chronic samples, even after controlling for defeatist beliefs, affect recognition and neurocognitive functioning. Metacognitive deficits are also associated with concurrent and future negative symptoms when controlling for verbal memory and education. Interestingly, self-reflection in itself has been found to mediate the relationship between neurocognition and negative symptoms (especially for deficits in capacity to communicate about internal states, so called diminished expression) while interpersonal cognitive differentiation (i.e., the ability to construe one's experiences as either similar or different from others' experiences) has been found to mediate the pathway between self-reflectivity and negative symptoms. This suggests that negative symptom reduction may at least partially depend on improved metacognitive capacity and that a metacognitive intervention specifically targeting negative symptoms may be beneficial.
Swanson et al. (2021) therefore adapted MCT for negative symptoms to assess the acceptability and feasibility of the intervention, examine variable change over the course of the intervention and carry out a preliminary investigation of putative mechanisms of change. The current project is a further evaluation of this, where the researchers hope to achieve similarly encouraging results in a randomised controlled trial (RCT) with a control group and blinding. The researchers also hope to replicate the findings of a previous study where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity. Importantly, it was found that high network homogeneity levels at baseline in the bilateral superior medial prefrontal cortex could predict symptomatic improvement after 8 weeks of drug plus psychotherapy treatment; this illustrates that a more developed understanding of the biological mechanisms underlying negative symptoms would allow us to identify patients that would benefit from each type of treatment and, through that, change the prognosis and treatment outcomes of the condition.
Significance and scientific novelty:
Research funding has been given for a RCT to evaluate the intervention trialled by Swanson et al, 2021 in a more rigorous and scientific manner. Given our limited understanding of negative symptoms and how to treat them, the study would be of both significance and scientific novelty. To fully understand the biological mechanisms behind negative symptoms is essential to be able to develop future treatment options and to identify patients that would benefit from each type of treatment. A more thorough understanding of schizophrenia would decrease the heterogeneity of the condition which would have vast implications for how individuals diagnosed with schizophrenia are treated both in society and in the healthcare setting.
Previous results:
Two articles (which were based on the main researcher's doctoral thesis at Edinburgh University with funding from National Health Service (NHS) Lothian) have been published in Clinical Psychology and Psychotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Training for Negative Symptoms | Experimental | Other: Metacognitive Training for Negative Symptoms (MCT)The original MCT intervention was adapted to negative symptoms by incorporating psychoeducation and strategies to target the cognitions suggested by the cognitive model (Beck et al., 2009) to be implicated in the development and/or maintenance of negative symptoms. Although some of the strategies have traditionally been used to target positive symptoms, it is assumed that the same reasoning styles lead to negative symptoms through the dysfunctional cognitions discussed previously (e.g., jumping to conclusions in regard to social rejection and a dysfunctional attribution style reinforcing social withdrawal). Metacognitive training for negative symptoms consists of eight sessions, delivered individually as there is evidence indicating that this approach may lead to stronger effect sizes than delivery in a group format (Liu et al., 2018). The developer of MCT (Professor Steffen Moritz) approved the modification. |
| Control group | Active comparator | Other: Supportive CounsellingSupportive Counselling (8 sessions) will be used as a control. Participants enrolled in this condition can then get the intervention if they request this. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 18
- Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis
- Resident in Region Sörmland, Region Västmanland or Region Uppland
Key exclusion criteria (5 listed)
- Evidence of severe organic brain dysfunction
- Learning disabilities
- Difficulty with the Swedish language
- Visual and/or hearing impairment
- Being unable or unwilling to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training for Negative Symptoms (MCT)See arm/group descriptions | Other | Metacognitive Training for Negative Symptoms |
| Supportive CounsellingSe arm/group descriptions | Other | Control group |
Primary outcome
The Clinical Assessment Interview for Negative Symptoms (CAINS) (Forbes et al., 2011)
Time frame: 15 minutes
Clincial interview to assess negative symptoms. Minimum value is 0 = better outcome. Maximum value is 52 = worse outcome.
The Motivation and Pleasure Scale- Self-Report (MAP-SR) (Llerena et al., 2013)
Time frame: 5 minutes
Self-rated questionnaire to assess negative symptoms Minimum value is 0 = better outcome. Maximum value is 90 = worse outcome.
The Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987)
Time frame: 20 minutes
Clinical interview to assess negative symptoms (analysed with the five factor-model) Minimum value is 0 = better outcome. Maximum value is 210 = worse outcome.
5 secondary outcomes
The Dysfunctional Attitudes Scale (DAS) (Weissman & Beck, 1978)
Time frame: 5 minutes
The Reflective Functioning Questionnaire (RFQ-8) (Fonagy et al., 2016)
Time frame: 5 minutes
The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) (Hammer & Toland, 2017)
Time frame: 5 minutes
The Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington, & Schissel, 1990)
Time frame: 10 minutes
The World Health Organization (WHO) Disability Assessment Schedule (WHODAS) 2.0 (WHO, 2010)
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 2278986Addington D, Addington J, Schissel B. A depression rating scale for schizophrenics. Schizophr Res. 1990 Jul-Aug;3(4):247-51. doi: 10.1016/0920-9964(90)90005-r.
- Background: PubMed 27293137Aleman A, Lincoln TM, Bruggeman R, Melle I, Arends J, Arango C, Knegtering H. Treatment of negative symptoms: Where do we stand, and where do we go? Schizophr Res. 2017 Aug;186:55-62. doi: 10.1016/j.schres.2016.05.015. Epub 2016 Jun 9.
- BackgroundAmerican Psychiatric Association (APA). (1987). Diagnostic and statistical manual of mental disorders (3rd edition, revised) (DSM-III-TR). APA.
- BackgroundAustin, S. F., Lysaker, P. H., Jansen, J. E., Trauelsen, A. M., Nielsen, H.-G. L., Pedersen, M. B., Haahr, U. H., & Simonsen, E. (2019). Metacognitive capacity and negative symptoms in first episode psychosis: Evidence of a prospective relationship over a 3-year follow-up. Journal of Experimental Psychopathology, 10(1). doi: 10.1177/2043808718821572
- BackgroundBeck, A. T., Rector, N. A., Stolar, N., & Grant, P. (2009). Schizophrenia: cognitive theory, research and therapy. Guilford Press.
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- Individual participant dataSharing planned: No. Data can be shared on request with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Cervenka, Prof contact
Linda Swanson, Dr principal investigator
Region Sörmland/ Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training for Negative Symptoms (MCT) and Supportive Counselling in people with Negative Symptoms in Schizophrenia, run by Sormland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Swanson, Dr (0046-720 843 708, linda.swanson@regionsormland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinical Assessment Interview for Negative Symptoms (CAINS) (Forbes et al., 2011) (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127004, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.