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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Therapy
• Intervention / Treatment: Other: group cognitive stimulation therapy; Other: usual care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Chi Chang, MSN; Phone Number: 3317 886-3-211-8999; Email: ccchang@mail.cgust.edu.tw
• Study Contact Backup: Name: Chiu-Yueh Yang, PhD; Phone Number: 7388 886-2-2826; Email: cyyang3@ym.edu.tw

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • Recruiting
    • National Yang-Ming Jiaotong University
    • Contact: Yang Chiu Yueh, PhD; Phone Number: 02-28267388; Email: cyyang3@ym.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exploring the effectiveness of GCST in people with schizophrenia.; The experimental group will receive a total of 14 sessions, twice a week group cognitive stimulation therapy for 7 weeks.	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).; Other Names: GCST; Other: usual care; The control group maintains the unit routine treatment.
No Intervention: Control group; The control group maintains the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory II, BDI-II	Depressive symptoms test	baseline
Social Function Scales-Taiwanese version, SFST	Social Function test	baseline
WHOQOL-BREF	quality of life test	baseline

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Chiu-Yueh Yang, PhD, National Yang-Ming Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; schizophrenia; social function; depressive symptoms; cognitive stimulation therapy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: IRB1081209-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No