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Metacognitive Intervention for Individuals With Severe Mental Disorders

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metacognitive Group Intervention
Occupational therapy standard care
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Executive function, Meta-cognition, Schizophrenia, Meta-cognitive intervention

Eligibility Criteria

23 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of schizophrenia by a licensed psychiatrist
  • Fluency in Hebrew
  • t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version

Exclusion Criteria:

  • Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
  • Used drugs or alcohol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Metacognitive Group Intervention

    Occupational therapy standard care

    Arm Description

    Meta cognitive intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored to individuals with schizophrenia.

    Standard care of occupational therapy in mental health, focused on work occupations.

    Outcomes

    Primary Outcome Measures

    Positive and Negative Syndrome Scale
    The Positive and Negative Syndrome Scale is a 30-item scale with seven positive and seven negative symptoms items and 16 psychopathological items. The severity of each item is rated on a scale from 1 (none) to 7 (most severe). A general Positive and Negative Syndrome Scale score is between 30 (lack of symptoms) and 210 (very severe state of the disease). Potential ranges are 7 to 49 for the positive and negative symptom scales and from 16 to 12 for the general psychopathology scale.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2022
    Last Updated
    September 29, 2022
    Sponsor
    University of Haifa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05556941
    Brief Title
    Metacognitive Intervention for Individuals With Severe Mental Disorders
    Official Title
    Development and Efficacy of Metacognitive Intervention for Individuals With Severe Mental Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    April 30, 2016 (Actual)
    Study Completion Date
    April 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Haifa

    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
    The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia
    Detailed Description
    The overall aim of this study was to develop a Meta cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia. The specific objectives were to: Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness. Compare the use of cognitive strategies between participants with schizophrenia and their matched controls following the Meta cognitive group intervention and to correlate the cognitive strategies use and participation following the Meta cognitive group. Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Executive function, Meta-cognition, Schizophrenia, Meta-cognitive intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Before and after intervention
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metacognitive Group Intervention
    Arm Type
    Experimental
    Arm Description
    Meta cognitive intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored to individuals with schizophrenia.
    Arm Title
    Occupational therapy standard care
    Arm Type
    Active Comparator
    Arm Description
    Standard care of occupational therapy in mental health, focused on work occupations.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Metacognitive Group Intervention
    Intervention Description
    The investigators developed an initial Meta cognitive group intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored it to individuals with schizophrenia.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Occupational therapy standard care
    Intervention Description
    Occupational therapy standard care
    Primary Outcome Measure Information:
    Title
    Positive and Negative Syndrome Scale
    Description
    The Positive and Negative Syndrome Scale is a 30-item scale with seven positive and seven negative symptoms items and 16 psychopathological items. The severity of each item is rated on a scale from 1 (none) to 7 (most severe). A general Positive and Negative Syndrome Scale score is between 30 (lack of symptoms) and 210 (very severe state of the disease). Potential ranges are 7 to 49 for the positive and negative symptom scales and from 16 to 12 for the general psychopathology scale.
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    68 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of schizophrenia by a licensed psychiatrist Fluency in Hebrew t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version Exclusion Criteria: Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study Used drugs or alcohol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Naomi Josman, PhD
    Organizational Affiliation
    University of Haifa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    In accordance with the Helsinki Declaration and University ethical committee principles, the data used in this study cannot be made available because it was not anonymous.
    Citations:
    PubMed Identifier
    30482631
    Citation
    Kaizerman-Dinerman A, Roe D, Josman N. An efficacy study of a metacognitive group intervention for people with schizophrenia. Psychiatry Res. 2018 Dec;270:1150-1156. doi: 10.1016/j.psychres.2018.10.037. Epub 2018 Oct 13.
    Results Reference
    result
    Citation
    Kaizerman-Dinerman A, Josman, Roe D. The use of cognitive strategies among people with schizophrenia: a randomized comparative study. The Open Journal of Occupational Therapy. 2019; 7(3): 1-12.
    Results Reference
    result

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    Metacognitive Intervention for Individuals With Severe Mental Disorders

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