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Clinical Trials/NCT04916483
NCT04916483
Unknown
Not Applicable

Exploring the Effectiveness of Group Cognitive Stimulation Therapy on Cognitive Function, Depressive Symptoms, Social Function and Quality of Life in People With Schizophrenia: A Randomized Controlled Trial

National Yang Ming Chiao Tung University1 site in 1 country90 target enrollmentJanuary 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Therapy
Sponsor
National Yang Ming Chiao Tung University
Enrollment
90
Locations
1
Primary Endpoint
Montreal Cognitive Assessment, MoCA
Last Updated
4 years ago

Overview

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.

Detailed Description

Background: Cognitive dysfunction is the core defect of schizophrenia, which seriously affects the emotional and social functions of patients. Group cognitive stimulation therapy has been supported by research abroad to improve cognition and mood. Domestically, this group of people with schizophrenia will also face the above symptoms. Therefore, non-pharmacological therapy is among mental health personnel It is worth paying attention to and developing in the process of providing medical services. Objective: The purpose of this study explores 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 to reduce it to people with schizophrenia.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 EG and the CG using blocking. The EG receive 7 weeks, twice a week, 60 minutes each time of GCST, the CG maintain usual care. Both groups use the Montreal Cognitive Assessment Scale (MoCA), the Taiwanese Version of Frontal Assessment Battery (TFAB), the Beck Depression Inventory II (Beck Depression Inventory II, BDI-II), and Social Function Scales-Taiwanese version(SFST) and WHOQOL-BREF is use as an evaluation tool to measure the results at the baseline, T1 (7th weeks) and T2 (20th weeks). The research results were filed and statistically analyzed with IBM SPSS 20.0 software package. Descriptive statistics were used for general demographic variables and primary , secondary outcome: mean, SD, range, percentage. The difference between the two groups of benchmark values was analyzed with t-test or χ2, independent-t test, pair-t, and GEE. Expected results: GCST can improve cognitive function, depressive symptoms, social function and quality of life in people with schizophrenia.

Registry
clinicaltrials.gov
Start Date
January 15, 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chiu-Yueh Yang

Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • According to DSM-5 criteria, suspected bipolar disorder, anxiety disorder, obsessive- compulsive disorder, cognitive impairment, substance use disorders, and other unthinking disorders are exclusion.
  • 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.

Outcomes

Primary Outcomes

Montreal Cognitive Assessment, MoCA

Time Frame: baseline

Cognitive function test

Taiwanese Version of Frontal Assessment Battery, TFAB

Time Frame: baseline

Cognitive function test

Wechsler Memory Scale-Third Edition, WMS-III

Time Frame: baseline

Cognitive function test

Secondary Outcomes

  • Beck Depression Inventory II, BDI-II(baseline)
  • Social Function Scales-Taiwanese version, SFST(baseline)
  • WHOQOL-BREF(baseline)

Study Sites (1)

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