Metacognitive Intervention for Individuals With Severe Mental Disorders

September 29, 2022 updated by: Naomi Josman, University of Haifa

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness.
  2. 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.
  3. Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale
Time Frame: 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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Investigators

  • Principal Investigator: Naomi Josman, PhD, University of Haifa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

April 30, 2016

Study Completion (ACTUAL)

April 30, 2016

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (ACTUAL)

September 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kaizerman-Dinerman2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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