Metacognitive Intervention for Individuals With Severe Mental Disorders

Sponsor

University of Haifa (Other)

Overall Status

Completed

CT.gov ID

NCT05556941

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Metacognitive Group Intervention Behavioral: Occupational therapy standard care	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Before and after interventionBefore and after intervention

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Apr 30, 2016

Actual Study Completion Date :

Apr 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metacognitive Group Intervention 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 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.
Active Comparator: Occupational therapy standard care Standard care of occupational therapy in mental health, focused on work occupations.	Behavioral: Occupational therapy standard care Occupational therapy standard care

Arm

Intervention/Treatment

Experimental: Metacognitive Group Intervention

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

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.

Active Comparator: Occupational therapy standard care

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

Behavioral: Occupational therapy standard care

Occupational therapy standard care

Outcome Measures

Primary Outcome Measures

Positive and Negative Syndrome Scale [15 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 68 Years

Sexes Eligible for Study:

All

Accepts 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