xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005766</url>
    </required_header>
    <id_info>
      <org_study_id>VVSJYUMCT01</org_study_id>
      <nct_id>NCT06005766</nct_id>
    </id_info>
    <brief_title>The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Jyvaskyla</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Vanha Vaasa Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Jyvaskyla</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Deficiencies in social cognition are part of the core symptomatology of psychotic disorders.&#xD;
        And deficiencies in social cognition, the closely related concept of metacognition, and, for&#xD;
        example, paranoid attitudes are all associated with violence. The link between social&#xD;
        cognition and violence is also observed through rehabilitation, as both group-based Social&#xD;
        Cognition Interaction Training (SCIT) and group-based Metacognitive Skills Training (MCT)&#xD;
        have reduced violent behavior in patients with psychotic disorders. Thus, a better knowledge&#xD;
        of social cognition and its rehabilitation in psychotic disorders can help to reduce risky&#xD;
        behavior and to rehabilitate the significant social difficulties often found in psychotic&#xD;
        disorders. This research study aims to examine factors underlying the efficacy of group-based&#xD;
        MCT.&#xD;
  &#xD;
        The goal of the metacognitive skills training group developed by Moritz and partners is to&#xD;
        strengthen the social and metacognitive skills of the patients participating in the group.&#xD;
        The group consists of 10 sessions during which exercises and discussion are emphasized. The&#xD;
        themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and&#xD;
        memory. Detailed information is available from the MCT website&#xD;
        (https://clinical-neuropsychology.de/metacognitive_training-psychosis/). Overall there is&#xD;
        meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of&#xD;
        psychotic illnesses, such as delusions. Prior studies have argued that the unique factor&#xD;
        underpinning MCT's efficacy is its impact on various cognitive biases, and that participating&#xD;
        in the group especially reduces patients' tendency to jump to conclusions, which is a&#xD;
        cognitive style associated with delusions and deficits in social perception and reasoning. As&#xD;
        delusionality is related to the risk of violence, these results form a logical link between&#xD;
        jumping to conclusions, delusionality, and violence.&#xD;
  &#xD;
        But the results regarding the effectiveness of MCT are still somewhat conflicting, and&#xD;
        studies seem to be of varying quality. Additional longitudinal research and research related&#xD;
        to the jumping to conclusion bias are also needed. The hypothesis regarding this study is&#xD;
        that the MCT group reduces patients' tendency to jump to conclusions. These reductions are&#xD;
        presumed to be associated in one-year follow-up with fewer mood symptoms, delusions,&#xD;
        paranoia, and more psychological flexibility.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Based on their multi-professional treatment plan in the Vanha Vaasa hospital, participation&#xD;
        in the MCT group intervention is offered to patients who could benefit from it. The&#xD;
        intervention under investigation is part of the standard care of the hospital. Participation&#xD;
        does not prevent participation in other forms of rehabilitation, and patients can participate&#xD;
        in the group even if they don't participate in the study. Being part of the control group&#xD;
        does not prevent participation in the intervention group, but being part of the control group&#xD;
        might delay participation. When these are in conflict, treatment takes precedence over&#xD;
        research.&#xD;
  &#xD;
        Data is collected until the sample size is satisfactory (at least 20 to 25 patients).&#xD;
        Patients in the MCT condition are compared to patients (n=30) and controls (n=30) measured&#xD;
        with a psychological test battery not completing the group. The test battery is the same for&#xD;
        all the groups. It consists of valid tasks measuring neurocognition, social cognition, and&#xD;
        psychiatric symptoms and a task for measuring the tendency to jump to conclusions. Patients&#xD;
        in the group condition are tested before the group and nine months after the group has&#xD;
        concluded. For both control groups testing interval is one year.&#xD;
  &#xD;
        The comparison between the groups (intervention group, patient controls, and non-patient&#xD;
        controls) is done by comparing the rate of change in the tendency to jump to conclusions.&#xD;
        This comparison is done with regression analysis. If minor differences and equal variances&#xD;
        are assumed (delta of slope 0.1), the power of the comparison is around 0.57. If larger&#xD;
        differences are assumed (delta of slope 0.5), the power of the comparison approaches 1. In a&#xD;
        previous study, a medium-sized comparative difference between patients in MCT condition and&#xD;
        patients in cognitive remediation condition was found.&#xD;
  &#xD;
        To avoid problems with multiple testing, the differences in magnitudes of mood symptoms,&#xD;
        delusions, paranoia, and psychological flexibility after the delay are assessed with MANOVA.&#xD;
        In a recent meta-analysis, the observed effect of MCT on delusions was high medium (g=0.69).&#xD;
        The observed effect on negative symptoms was small but significant (g=0.23). Consequently,&#xD;
        the expected power of the MANOVA ranges from 0.48 to 0.99. Direct comparisons are made with&#xD;
        discriminant analysis with identical power estimates. Univariate ANOVAs can also be used, but&#xD;
        with much worse power estimates, when controlling for multiple testing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Jumping to conclusions bias</measure>
      <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.</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Paranoia and psychotic experiences</measure>
      <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.</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood symptoms</measure>
      <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.</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological flexibility</measure>
      <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.</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Schizophrenia</condition>
    <condition>Schizoaffective Disorder</condition>
    <condition>Psychotic Disorders</condition>
    <condition>Delusional Disorder</condition>
    <condition>Psychotic Depression</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patient controls</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with a psychosis spectrum disorder receiving standard long-term care in the hospital</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-patient controls</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Metacognitive Skills Training (MCT)</intervention_name>
      <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.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment as usual</intervention_name>
      <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)</description>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_label>Patient controls</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (patients):&#xD;
  &#xD;
            -  Willingness to participate in a scientific study&#xD;
  &#xD;
            -  Diagnosis of a psychosis spectrum disorder&#xD;
  &#xD;
            -  Finnish language skills due to questionnaires and psychological tests being in Finnish&#xD;
  &#xD;
          Exclusion Criteria (patients):&#xD;
  &#xD;
            -  Psychosis that severely deteriorates the ability to function&#xD;
  &#xD;
            -  Cognitive problems that severely deteriorate the ability to function&#xD;
  &#xD;
            -  Guardianship established for personal matters&#xD;
  &#xD;
          Inclusion Criteria (non-patient controls):&#xD;
  &#xD;
            -  Willingness to participate in a scientific study&#xD;
  &#xD;
            -  Self-assessed sufficient Finnish language skills due to questionnaires and&#xD;
               psychological tests being in Finnish&#xD;
  &#xD;
          Exclusion Criteria (non-patient controls):&#xD;
  &#xD;
            -  Diagnosis of a psychosis spectrum disorder&#xD;
  &#xD;
            -  Cognitive problems that severely interferes with functioning&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Raimo Lappalainen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Jyvaskyla</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leo Kuutti, MA</last_name>
      <phone>029 524 3058</phone>
      <phone_ext>+358</phone_ext>
      <email>leo.kuutti@vvs.fi</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alice Keski-Valkama, PhD</last_name>
      <phone>029 524 3055</phone>
      <phone_ext>+358</phone_ext>
      <email>Alice.keski-valkama@vvs.fi</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Social Cognition</keyword>
    <keyword>Metacognitive Skills Training</keyword>
    <keyword>Forensic Psychology</keyword>
    <keyword>Forensic Psychiatry</keyword>
    <keyword>Violence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Schizophrenia, Paranoid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005766
  org study id: VVSJYUMCT01
  nct id: NCT06005766
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention 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).
  primary purpose: Treatment
  masking: None (Open Label)
  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.
  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.
  measure: 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.
  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
  measure: 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.
  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.
  measure: 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.
  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.
  arm group label: Intervention group
  arm group type: Experimental
  description: Patients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual
  arm group label: Patient controls
  arm group type: Active Comparator
  description: Patients with a psychosis spectrum disorder receiving standard long-term care in the hospital
  arm group label: Non-patient controls
  arm group type: No Intervention
  description: Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder
  intervention type: Behavioral
  intervention name: Metacognitive Skills Training (MCT)
  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.
  arm group label: Intervention group
  intervention type: Other
  intervention name: Treatment as usual
  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)
  arm group label: Intervention group
  arm group label: Patient controls
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Raimo Lappalainen, PhD
  role: Principal Investigator
  affiliation: University of Jyvaskyla
  last name: Leo Kuutti, MA
  phone: 029 524 3058
  phone ext: +358
  email: leo.kuutti@vvs.fi
  last name: Alice Keski-Valkama, PhD
  phone: 029 524 3055
  phone ext: +358
  email: Alice.keski-valkama@vvs.fi
  responsible party type: Sponsor
  mesh term: Schizophrenia
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  mesh term: Schizophrenia, Paranoid
  sharing ipd: Yes
  ipd 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.