- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040998
Compensatory Cognitive Training For Schizophrenia
July 30, 2019 updated by: YU SHIUAN LIAW, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Compensatory Cognitive Training for Psychosocial Correlates and Self-stigma in Persons With Schizophrenia
This study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taoyuan, Taiwan, 330
- Taoyuan Psychiatric Center Ministry of Health and Welfare
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-
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
18 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
- age from 20 to 65
- attending day care center regularly for at least 3 months
- taking stable dose of medication for at least 3 months
Exclusion Criteria:
- comorbid autism spectrum disorder
- comorbid mental retardation
- lacking the reading and writing skills
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CCT+TAU group
The participants in CCT+TAU group received compensatory cognitive training plus treatment as usual.
The CCT intervention consisted of two 50-minute sessions each week for 10 weeks
|
Teach the participants compensatory cognitive skills and strategies
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No Intervention: TAU group
The participants in TAU group received usual treatment at the same time as CCT+TAU group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change scores of Rosenberg Self-Esteem Scale (RSES)
Time Frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
|
The Chinese version of Rosenberg Self-Esteem Scale (RSES) was implemented as self-esteem measures.
The total score ranged from 10 to 40, with higher scores reflecting higher levels of self-esteem.
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3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
|
Change scores of General Self-Efficacy Scale (GSES)
Time Frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
|
The Chinese version of General Self-Efficacy Scale (GSES) consisted of 10 items, assessing optimistic self-beliefs to cope with a variety of difficult demands in life.
The total score ranged from 10 to 40, with higher scores indicating more self-efficacy.
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3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
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Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Time Frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
|
The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life.
The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.
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3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
|
Change scores of Internalized Stigma of Mental Illness (ISMIS)
Time Frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
|
The Chinese version of Internalized Stigma of Mental Illness (ISMIS) consists of 29 items incorporated in five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance.
The total scores range from 29-116.
The higher scores on the ISMIS indicates more severe internalized stigmatization.
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3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 5, 2018
Primary Completion (Actual)
May 31, 2018
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
July 30, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
August 1, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TaoyuanMH
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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