Clinical trial NCT04916483: Exploring the Effectiveness of Group Cognitive Stimulation Therapy in People With Schizophrenia.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Therapy
Keywords: cognitive stimulation therapy
depressive symptoms
schizophrenia
social function
quality of life
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were divided into experimental group and control group through block randomization
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment, MoCA
timeFrame: baseline
measure: Taiwanese Version of Frontal Assessment Battery, TFAB
timeFrame: baseline
measure: Wechsler Memory Scale-Third Edition, WMS-III
timeFrame: baseline
Secondary outcomes:
measure: Beck Depression Inventory II, BDI-II
timeFrame: baseline
measure: Social Function Scales-Taiwanese version, SFST
timeFrame: baseline
measure: WHOQOL-BREF
timeFrame: baseline
Other outcomes:
measure: Montreal Cognitive Assessment, MoCA
timeFrame: 7th weeks
measure: Taiwanese Version of Frontal Assessment Battery, TFAB
timeFrame: 7th weeks
measure: Wechsler Memory Scale-Third Edition, WMS-III
timeFrame: 7th weeks
measure: Beck Depression Inventory II, BDI-II
timeFrame: 7th weeks
measure: Social Function Scales-Taiwanese version, SFST
timeFrame: 7th weeks
measure: WHOQOL-BREF
timeFrame: 7th weeks
measure: Montreal Cognitive Assessment, MoCA
timeFrame: 20th week
measure: Taiwanese Version of Frontal Assessment Battery, TFAB
timeFrame: 20th week
measure: Wechsler Memory Scale-Third Edition, WMS-III
timeFrame: 20th week
measure: Beck Depression Inventory II, BDI-II
timeFrame: 20th week
measure: Social Function Scales-Taiwanese version, SFST
timeFrame: 20th week
measure: WHOQOL-BREF
timeFrame: 20th week
Locations:
city: Taipei City
country: Taiwan
facility: National Yang-Ming Jiaotong University
Study officials:
affiliation: National Yang-Ming Jiaotong University
name: Chiu-Yueh Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: