SchizophreniaNCT06005766
The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care
A study testing Metacognitive Skills Training (MCT) and Treatment as usual in people with Schizophrenia and Schizoaffective Disorder, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
Deficiencies in social cognition are part of the core symptomatology of psychotic disorders. And deficiencies in social cognition, the closely related concept of metacognition, and, for example, paranoid attitudes are all associated with violence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- What is being tested?
- Metacognitive Skills Training (MCT) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2023to Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate in a scientific study
- Diagnosis of a psychosis spectrum disorder
- Finnish language skills due to questionnaires and psychological tests being in Finnish
- Willingness to participate in a scientific study
- Self-assessed sufficient Finnish language skills due to questionnaires and psychological tests being in Finnish
Who cannot join
- Psychosis that severely deteriorates the ability to function
- Cognitive problems that severely deteriorate the ability to function
- Guardianship established for personal matters
- Diagnosis of a psychosis spectrum disorder
- Cognitive problems that severely interferes with functioning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Vanha Vaasa Hospital
Vaasa
Leo Kuutti, +358295243058, leo.kuutti@vvs.fi
About this study
Official title: Does Group-Based Metacognitive Skills Training Reduce Jumping to Conclusions Bias of Patients With Psychotic Disorders in the Context of Forensic Psychiatric Care
Deficiencies in social cognition are part of the core symptomatology of psychotic disorders. And deficiencies in social cognition, the closely related concept of metacognition, and, for example, paranoid attitudes are all associated with violence. The link between social cognition and violence is also observed through rehabilitation, as both group-based Social Cognition Interaction Training (SCIT) and group-based Metacognitive Skills Training (MCT) have reduced violent behavior in patients with psychotic disorders. Thus, a better knowledge of social cognition and its rehabilitation in psychotic disorders can help to reduce risky behavior and to rehabilitate the significant social difficulties often found in psychotic disorders. This research study aims to examine factors underlying the efficacy of group-based MCT.
The goal of the metacognitive skills training group developed by Moritz and partners is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning. As delusionality is related to the risk of violence, these results form a logical link between jumping to conclusions, delusionality, and violence.
But the results regarding the effectiveness of MCT are still somewhat conflicting, and studies seem to be of varying quality. Additional longitudinal research and research related to the jumping to conclusion bias are also needed. The hypothesis regarding this study is that the MCT group reduces patients' tendency to jump to conclusions. These reductions are presumed to be associated in one-year follow-up with fewer mood symptoms, delusions, paranoia, and more psychological flexibility.
Read the detailed description
Based on their multi-professional treatment plan in the Vanha Vaasa hospital, participation in the MCT group intervention is offered to patients who could benefit from it. The intervention under investigation is part of the standard care of the hospital. Participation does not prevent participation in other forms of rehabilitation, and patients can participate in the group even if they don't participate in the study. Being part of the control group does not prevent participation in the intervention group, but being part of the control group might delay participation. When these are in conflict, treatment takes precedence over research.
Data is collected until the sample size is satisfactory (at least 20 to 25 patients). Patients in the MCT condition are compared to patients (n=30) and controls (n=30) measured with a psychological test battery not completing the group. The test battery is the same for all the groups. It consists of valid tasks measuring neurocognition, social cognition, and psychiatric symptoms and a task for measuring the tendency to jump to conclusions. Patients in the group condition are tested before the group and nine months after the group has concluded. For both control groups testing interval is one year.
The comparison between the groups (intervention group, patient controls, and non-patient controls) is done by comparing the rate of change in the tendency to jump to conclusions. This comparison is done with regression analysis. If minor differences and equal variances are assumed (delta of slope 0.1), the power of the comparison is around 0.57. If larger differences are assumed (delta of slope 0.5), the power of the comparison approaches 1. In a previous study, a medium-sized comparative difference between patients in MCT condition and patients in cognitive remediation condition was found.
To avoid problems with multiple testing, the differences in magnitudes of mood symptoms, delusions, paranoia, and psychological flexibility after the delay are assessed with MANOVA. In a recent meta-analysis, the observed effect of MCT on delusions was high medium (g=0.69). The observed effect on negative symptoms was small but significant (g=0.23). Consequently, the expected power of the MANOVA ranges from 0.48 to 0.99. Direct comparisons are made with discriminant analysis with identical power estimates. Univariate ANOVAs can also be used, but with much worse power estimates, when controlling for multiple testing.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders, Delusional Disorder, Psychotic Depression
- Being tested
- Metacognitive Skills Training (MCT), Treatment as usual
- Keywords
- Social Cognition, Metacognitive Skills Training, Forensic Psychology, Forensic Psychiatry, Violence
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Skills Training (MCT)Behavioural
The goal of the metacognitive skills training group developed by Moritz and co. is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning.
Treatment as usualOther
Medicinal treatment deemed appropriate by the attending physician, psychiatric ward treatment, and others forms of treatment recommended to the patients based on their treatment plans (e.g., work therapy, dialectical behavior therapy, talk therapy)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual Receives: Behavioral: Metacognitive Skills Training (MCT); Other: Treatment as usual |
| Patient controls | Active comparator | Patients with a psychosis spectrum disorder receiving standard long-term care in the hospital Receives: Other: Treatment as usual |
| Non-patient controls | No intervention | Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jumping to conclusions bias
The bias is measured using a revised version of the beads task. This is a test of optimal performance, meaning that both low and high scores can be problematic.
Measured: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
Secondary outcomes (3)
Paranoia and psychotic experiences
Paranoia and psychotic experiences assessed with the Symptoms Checklist 90 self-report questionnaire. The scale for paranoia goes from 0 to 24 with higher scores meaning worse outcome. The scale for psychotic experiences goes from 0 to 40 with higher scores meaning worse outcome
Measured: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
Mood symptoms
Mood symptoms assessed with Symptoms Checklist 90 self-report questionnaire. The sum for scales measuring depression and anxiety goes from 0 to 92 with higher scores meaning worse outcome.
Measured: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
Psychological flexibility
Psychological flexibility assessed with the the comprehensive assessment of acceptance and commitment therapy processes - Short Form (CompACT-8) self-report questionnaire. The total CompACT score ranges from 0-48, with higher scores indicating greater psychological flexibility: The ability to attend and adapt to situational demands in the pursuit of personally-meaningful longer-term goals.
Measured: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups in the study. One is the intervention group (n=20-25), one consists of patient controls (n=30), and the last one consists of non-patient controls (n=30).
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Vanha Vaasa Hospital
- Responsible party
- Sponsor
- Investigators
- Raimo Lappalainen, PhD, Principal investigator, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005766
- Sponsor's protocol ID
- VVSJYUMCT01
- Status last verified
- May 2024
- First submitted
- 15 Aug 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Ownership of the data will reside with the University of Jyväskylä and Vanha Vaasa Hospital. The data are managed by the Ph.D. student, the PI, and the rest of the research team. Other researchers can use the data; however, it requires a research plan and the permission of the research team. Principally, the Ph.D. student, the PI, or someone from the research team will be one of the co-authors in all publications written from the data.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Group-Based Metacognitive Skills Training Reduce Jumping to Conclusions Bias of Patients With Psychotic Disorders in the Context of Forensic Psychiatric Care
- ClinicalTrials.gov ID
- NCT06005766
- Acronym / sponsor ID
- VVSJYUMCT01
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders, Delusional Disorder, Psychotic Depression
- Keywords
- Social Cognition, Metacognitive Skills Training, Forensic Psychology, Forensic Psychiatry, Violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Vanha Vaasa Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 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.
Deficiencies in social cognition are part of the core symptomatology of psychotic disorders. And deficiencies in social cognition, the closely related concept of metacognition, and, for example, paranoid attitudes are all associated with violence. The link between social cognition and violence is also observed through rehabilitation, as both group-based Social Cognition Interaction Training (SCIT) and group-based Metacognitive Skills Training (MCT) have reduced violent behavior in patients with psychotic disorders. Thus, a better knowledge of social cognition and its rehabilitation in psychotic disorders can help to reduce risky behavior and to rehabilitate the significant social difficulties often found in psychotic disorders. This research study aims to examine factors underlying the efficacy of group-based MCT.
The goal of the metacognitive skills training group developed by Moritz and partners is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning. As delusionality is related to the risk of violence, these results form a logical link between jumping to conclusions, delusionality, and violence.
But the results regarding the effectiveness of MCT are still somewhat conflicting, and studies seem to be of varying quality. Additional longitudinal research and research related to the jumping to conclusion bias are also needed. The hypothesis regarding this study is that the MCT group reduces patients' tendency to jump to conclusions. These reductions are presumed to be associated in one-year follow-up with fewer mood symptoms, delusions, paranoia, and more psychological flexibility.
Detailed description
Based on their multi-professional treatment plan in the Vanha Vaasa hospital, participation in the MCT group intervention is offered to patients who could benefit from it. The intervention under investigation is part of the standard care of the hospital. Participation does not prevent participation in other forms of rehabilitation, and patients can participate in the group even if they don't participate in the study. Being part of the control group does not prevent participation in the intervention group, but being part of the control group might delay participation. When these are in conflict, treatment takes precedence over research.
Data is collected until the sample size is satisfactory (at least 20 to 25 patients). Patients in the MCT condition are compared to patients (n=30) and controls (n=30) measured with a psychological test battery not completing the group. The test battery is the same for all the groups. It consists of valid tasks measuring neurocognition, social cognition, and psychiatric symptoms and a task for measuring the tendency to jump to conclusions. Patients in the group condition are tested before the group and nine months after the group has concluded. For both control groups testing interval is one year.
The comparison between the groups (intervention group, patient controls, and non-patient controls) is done by comparing the rate of change in the tendency to jump to conclusions. This comparison is done with regression analysis. If minor differences and equal variances are assumed (delta of slope 0.1), the power of the comparison is around 0.57. If larger differences are assumed (delta of slope 0.5), the power of the comparison approaches 1. In a previous study, a medium-sized comparative difference between patients in MCT condition and patients in cognitive remediation condition was found.
To avoid problems with multiple testing, the differences in magnitudes of mood symptoms, delusions, paranoia, and psychological flexibility after the delay are assessed with MANOVA. In a recent meta-analysis, the observed effect of MCT on delusions was high medium (g=0.69). The observed effect on negative symptoms was small but significant (g=0.23). Consequently, the expected power of the MANOVA ranges from 0.48 to 0.99. Direct comparisons are made with discriminant analysis with identical power estimates. Univariate ANOVAs can also be used, but with much worse power estimates, when controlling for multiple testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three groups in the study. One is the intervention group (n=20-25), one consists of patient controls (n=30), and the last one consists of non-patient controls (n=30).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Metacognitive Skills Training (MCT), Other: Treatment as usualPatients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual |
| Patient controls | Active comparator | Other: Treatment as usualPatients with a psychosis spectrum disorder receiving standard long-term care in the hospital |
| Non-patient controls | No intervention | –Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to participate in a scientific study
- Diagnosis of a psychosis spectrum disorder
- Finnish language skills due to questionnaires and psychological tests being in Finnish
- Willingness to participate in a scientific study
- Self-assessed sufficient Finnish language skills due to questionnaires and psychological tests being in Finnish
Key exclusion criteria (5 listed)
- Psychosis that severely deteriorates the ability to function
- Cognitive problems that severely deteriorate the ability to function
- Guardianship established for personal matters
- Diagnosis of a psychosis spectrum disorder
- Cognitive problems that severely interferes with functioning
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 Skills Training (MCT)The goal of the metacognitive skills training group developed by Moritz and co. is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning. | Behavioural | Intervention group |
| Treatment as usualMedicinal treatment deemed appropriate by the attending physician, psychiatric ward treatment, and others forms of treatment recommended to the patients based on their treatment plans (e.g., work therapy, dialectical behavior therapy, talk therapy) | Other | Intervention group, Patient controls |
Primary outcome
Jumping to conclusions bias
Time frame: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
The bias is measured using a revised version of the beads task. This is a test of optimal performance, meaning that both low and high scores can be problematic.
3 secondary outcomes
Paranoia and psychotic experiences
Time frame: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
Mood symptoms
Time frame: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
Psychological flexibility
Time frame: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.
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 14 May 2024.
- Individual participant dataSharing planned: Yes. Ownership of the data will reside with the University of Jyväskylä and Vanha Vaasa Hospital. The data are managed by the Ph.D. student, the PI, and the rest of the research team. Other researchers can use the data; however, it requires a research plan and the permission of the research team. Principally, the Ph.D. student, the PI, or someone from the research team will be one of the co-authors in all publications written from the data.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Raimo Lappalainen, PhD principal investigator
University of Jyvaskyla
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 Skills Training (MCT) and Treatment as usual in people with Schizophrenia and Schizoaffective Disorder, run by University of Jyvaskyla at 1 site in Finland.
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 5 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 14 May 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 Finland. 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 Leo Kuutti, MA (029 524 3058 ext. +358, leo.kuutti@vvs.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jumping to conclusions bias (time frame: For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.