Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.
1 other identifier
interventional
90
1 country
1
Brief Summary
Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional, social functions and quality of life in people with schizophrenia. Objective: The purpose of this study is to explore the efficacy of group cognitive stimulation therapy in cognitive function, depressive symptoms, social function, and quality of life in people with Schizophrenia. Research method:This study used a single-blind randomized controlled trial design. Participants's Montreal Cognitive Assessment Scale (MoCA) score between 10-25 points are include. Chronic rehabilitation wards were randomly assigned to the experimental group and the conventional treatment group using blocking. The experimental group (EG) (n = 45) is receive 7 weeks, twice a week, 60 minutes each time of group cognitive stimulation therapy(GCST), the control group (CG) (n = 45) maintain usual care. Expected results: GCST can improve cognitive function, depressive symptoms, social function and quality of life in people with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2020
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJune 7, 2021
June 1, 2021
8 months
April 9, 2020
June 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Montreal Cognitive Assessment, MoCA
Cognitive function test
baseline
Taiwanese Version of Frontal Assessment Battery, TFAB
Cognitive function test
baseline
Wechsler Memory Scale-Third Edition, WMS-III
Cognitive function test
baseline
Secondary Outcomes (3)
Beck Depression Inventory II, BDI-II
baseline
Social Function Scales-Taiwanese version, SFST
baseline
WHOQOL-BREF
baseline
Other Outcomes (12)
Montreal Cognitive Assessment, MoCA
7th weeks
Taiwanese Version of Frontal Assessment Battery, TFAB
7th weeks
Wechsler Memory Scale-Third Edition, WMS-III
7th weeks
- +9 more other outcomes
Study Arms (2)
Exploring the effectiveness of GCST in people with schizophrenia.
EXPERIMENTALThe experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks.
Control group
NO INTERVENTIONThe control group maintains the usual care.
Interventions
The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
The control group maintains the unit routine treatment.
Eligibility Criteria
You may qualify if:
- People who according the DSM-5 diagnosis of schizophrenia spectrum and have been sick for more than two years.
- Age between 20 and 65 years old.
- There are currently rules for receiving antipsychotics treatment.
- Regardless of whether you take antidepressants or not.
- Can communicate clearly in Mandarin and Taiwanese.
- Those with a score of 10-25 on the Montreal Cognitive Assessment Scale (MoCA).
- Those who are willing to participate in this study and complete the subject consent form.
You may not qualify if:
- Have been in or out of the acute ward within three months and currently have suicidal attempts or violence.
- Those who are receiving individual or group cognitive behavior therapy.
- People with intellectual disabilities.
- Those who are unable to conduct research due to visual or hearing impairment.
- People who are accepting other clinical trials.
- Those who have no intention to participate in this study or are unable to complete the subject's consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Yang-Ming Jiaotong University
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiu-Yueh Yang, PhD
National Yang-Ming Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- The questionnaire is distributed and applied by another researcher (non-investigator)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 9, 2020
First Posted
June 7, 2021
Study Start
January 15, 2021
Primary Completion
August 31, 2021
Study Completion
December 31, 2021
Last Updated
June 7, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share