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Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04916483
Enrollment
90
Registered
2021-06-07
Start date
2021-01-15
Completion date
2021-12-31
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Therapy

Keywords

cognitive stimulation therapy, depressive symptoms, schizophrenia, social function, quality of life

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.

Interventions

OTHERgroup cognitive stimulation therapy

The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).

OTHERusual care

The control group maintains the unit routine treatment.

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

The questionnaire is distributed and applied by another researcher (non-investigator)

Intervention model description

Participants were divided into experimental group and control group through block randomization

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. People who according the DSM-5 diagnosis of schizophrenia spectrum and have been sick for more than two years. 2. Age between 20 and 65 years old. 3. There are currently rules for receiving antipsychotics treatment. 4. Regardless of whether you take antidepressants or not. 5. Can communicate clearly in Mandarin and Taiwanese. 6. Those with a score of 10-25 on the Montreal Cognitive Assessment Scale (MoCA). 7. Those who are willing to participate in this study and complete the subject consent form.

Exclusion criteria

1. According to DSM-5 criteria, suspected bipolar disorder, anxiety disorder, obsessive- compulsive disorder, cognitive impairment, substance use disorders, and other unthinking disorders are exclusion. 2. Have been in or out of the acute ward within three months and currently have suicidal attempts or violence. 3. Those who are receiving individual or group cognitive behavior therapy. 4. People with intellectual disabilities. 5. Those who are unable to conduct research due to visual or hearing impairment. 6. People who are accepting other clinical trials. 7. Those who have no intention to participate in this study or are unable to complete the subject's consent form.

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment, MoCAbaselineCognitive function test
Wechsler Memory Scale-Third Edition, WMS-IIIbaselineCognitive function test
Taiwanese Version of Frontal Assessment Battery, TFABbaselineCognitive function test

Secondary

MeasureTime frameDescription
Beck Depression Inventory II, BDI-IIbaselineDepressive symptoms test
Social Function Scales-Taiwanese version, SFSTbaselineSocial Function test
WHOQOL-BREFbaselinequality of life test

Other

MeasureTime frameDescription
Montreal Cognitive Assessment, MoCA7th weeksCognitive function test
Wechsler Memory Scale-Third Edition, WMS-III7th weeksCognitive function test
Taiwanese Version of Frontal Assessment Battery, TFAB7th weeksCognitive function test
Beck Depression Inventory II, BDI-II7th weeksDepressive symptoms test
Social Function Scales-Taiwanese version, SFST7th weeksSocial Function test
WHOQOL-BREF7th weeksquality of life test

Countries

Taiwan

Contacts

Primary ContactChia-Chi Chang, MSN
ccchang@mail.cgust.edu.tw886-3-211-8999
Backup ContactChiu-Yueh Yang, PhD
cyyang3@ym.edu.tw886-2-2826

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026