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The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Psychotic Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metacognitive Skills Training (MCT)
Treatment as usual
Sponsored by
University of Jyvaskyla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Social Cognition, Metacognitive Skills Training, Forensic Psychology, Forensic Psychiatry, Violence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (patients): 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 Exclusion Criteria (patients): Psychosis that severely deteriorates the ability to function Cognitive problems that severely deteriorate the ability to function Guardianship established for personal matters Inclusion Criteria (non-patient controls): Willingness to participate in a scientific study Self-assessed sufficient Finnish language skills due to questionnaires and psychological tests being in Finnish Exclusion Criteria (non-patient controls): Diagnosis of a psychosis spectrum disorder Cognitive problems that severely interferes with functioning

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Intervention group

    Patient controls

    Non-patient controls

    Arm Description

    Patients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual

    Patients with a psychosis spectrum disorder receiving standard long-term care in the hospital

    Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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.
    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.

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 25, 2023
    Sponsor
    University of Jyvaskyla
    Collaborators
    Vanha Vaasa Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06005766
    Brief Title
    The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Jyvaskyla
    Collaborators
    Vanha Vaasa Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizoaffective Disorder, Psychotic Disorders, Delusional Disorder, Psychotic Depression
    Keywords
    Social Cognition, Metacognitive Skills Training, Forensic Psychology, Forensic Psychiatry, Violence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    85 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Patients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual
    Arm Title
    Patient controls
    Arm Type
    Active Comparator
    Arm Description
    Patients with a psychosis spectrum disorder receiving standard long-term care in the hospital
    Arm Title
    Non-patient controls
    Arm Type
    No Intervention
    Arm Description
    Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder
    Intervention Type
    Behavioral
    Intervention Name(s)
    Metacognitive Skills Training (MCT)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Treatment as usual
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Jumping to conclusions bias
    Description
    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.
    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.
    Secondary Outcome Measure Information:
    Title
    Paranoia and psychotic experiences
    Description
    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
    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.
    Title
    Mood symptoms
    Description
    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.
    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.
    Title
    Psychological flexibility
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria (patients): 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 Exclusion Criteria (patients): Psychosis that severely deteriorates the ability to function Cognitive problems that severely deteriorate the ability to function Guardianship established for personal matters Inclusion Criteria (non-patient controls): Willingness to participate in a scientific study Self-assessed sufficient Finnish language skills due to questionnaires and psychological tests being in Finnish Exclusion Criteria (non-patient controls): Diagnosis of a psychosis spectrum disorder Cognitive problems that severely interferes with functioning
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leo Kuutti, MA
    Phone
    029 524 3058
    Ext
    +358
    Email
    leo.kuutti@vvs.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alice Keski-Valkama, PhD
    Phone
    029 524 3055
    Ext
    +358
    Email
    Alice.keski-valkama@vvs.fi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raimo Lappalainen, PhD
    Organizational Affiliation
    University of Jyvaskyla
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.

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    The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care

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