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
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Executive function, Meta-cognition, Schizophrenia, Meta-cognitive intervention
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
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
NCT ID
NCT05556941
First Posted
September 22, 2022
Last Updated
September 29, 2022
Sponsor
University of Haifa
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
Learn more about this trial
Metacognitive Intervention for Individuals With Severe Mental Disorders
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