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
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment, MoCA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The questionnaire is distributed and applied by another researcher (non-investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Montreal Cognitive Assessment, MoCA
时间窗: baseline
Cognitive function test
Taiwanese Version of Frontal Assessment Battery, TFAB
时间窗: baseline
Cognitive function test
Wechsler Memory Scale-Third Edition, WMS-III
时间窗: baseline
Cognitive function test
次要结局
- Beck Depression Inventory II, BDI-II(baseline)
- Social Function Scales-Taiwanese version, SFST(baseline)
- WHOQOL-BREF(baseline)
研究者
Chiu-Yueh Yang
Professor
National Yang Ming Chiao Tung University