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

Cognitive Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916483
• Other study ID #: IRB1081209-04
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: National Yang Ming University
• Contact: Chia-Chi Chang, MSN
• Phone: 886-3-211-8999
• Email: ccchang[@]mail.cgust.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Therapy
• Schizophrenia

Intervention

Other:
• group cognitive stimulation therapy
The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
• usual care
The control group maintains the unit routine treatment.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming Jiaotong University	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Montreal Cognitive Assessment, MoCA	Cognitive function test	7th weeks
Other	Taiwanese Version of Frontal Assessment Battery, TFAB	Cognitive function test	7th weeks
Other	Wechsler Memory Scale-Third Edition, WMS-III	Cognitive function test	7th weeks
Other	Beck Depression Inventory II, BDI-II	Depressive symptoms test	7th weeks
Other	Social Function Scales-Taiwanese version, SFST	Social Function test	7th weeks
Other	WHOQOL-BREF	quality of life test	7th weeks
Other	Montreal Cognitive Assessment, MoCA	Cognitive function test	20th week
Other	Taiwanese Version of Frontal Assessment Battery, TFAB	Cognitive function test	20th week
Other	Wechsler Memory Scale-Third Edition, WMS-III	Wechsler Memory Scale-Third Edition, WMS-III	20th week
Other	Beck Depression Inventory II, BDI-II	Depressive symptoms test	20th week
Other	Social Function Scales-Taiwanese version, SFST	Social Function test	20th week
Other	WHOQOL-BREF	quality of life test	20th week
Primary	Montreal Cognitive Assessment, MoCA	Cognitive function test	baseline
Primary	Taiwanese Version of Frontal Assessment Battery, TFAB	Cognitive function test	baseline
Primary	Wechsler Memory Scale-Third Edition, WMS-III	Cognitive function test	baseline
Secondary	Beck Depression Inventory II, BDI-II	Depressive symptoms test	baseline
Secondary	Social Function Scales-Taiwanese version, SFST	Social Function test	baseline
Secondary	WHOQOL-BREF	quality of life test	baseline