Metacognitive Intervention for Individuals With Severe Mental Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Efficacy of Metacognitive Intervention for Individuals With Severe Mental Disorders

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Metacognitive Group Intervention
* Behavioral: Occupational therapy standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Before and after intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive Group Intervention<br>Meta cognitive intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored to individuals with schizophrenia. | Behavioral: Metacognitive Group Intervention<br>* 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.<br>|
| Active Comparator: Occupational therapy standard care<br>Standard care of occupational therapy in mental health, focused on work occupations. | Behavioral: Occupational therapy standard care<br>* Occupational therapy standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Executive function, Meta-cognition, Schizophrenia, Meta-cognitive intervention