Video Game-facilitated Group Activity for Quality of Life and Social Function in Chronic Schizophrenia Inpatients: A Randomized Controlled Parallel-group Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The changes of quality of life
研究概览
简要总结
The goal of this clinical trial is to learn if video game-facilitated group activity helps to improve the quality of life and social function in inpatients with chronic schizophrenia.
The main questions it aims to answer are:
- Does video game-facilitated group activity enhance the quality of life as measured by a standardized scale (WHOQOL) in patients with schizophrenia hospitalized in a psychiatric hospital?
- Can video game-facilitated group activity promote social function as measured by a specific scale (PSP) in patients with schizophrenia hospitalized in a psychiatric hospital?
Researchers will compare video game-facilitated group activity to regular occupational therapy to see if the intervention is beneficial to patients with chronic schizophrenia.
Participants will:
- Attend to video game-facilitated group activity or regular occupational therapy three times a week for 12 weeks.
- Receive assessments upon and after the 12-week intervention, and another 12 weeks after the intervention ends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Individuals aged between >18 and <65 years with a principal diagnosis of schizophrenia, as defined by the International Classification of Diseases (ICD-10) codes F20.0-F20.9 which was diagnosed according to DSM-5-TR criteria.
- •Possessing a valid Catastrophic Illness Certificate for schizophrenia and being continuously hospitalized for more than six months.
- •Being able to read Chinese and communicate effectively in either Mandarin or Taiwanese.
- •Being able to comprehend the purpose of the study and to provide written informed consent after the study has been explained by the researchers.
排除标准
- •Individuals exhibiting unstable psychiatric or consciousness conditions, or those unable to comply with video game-based instruction and operation.
- •Individuals with a history of ocular diseases, severe cardiovascular disorders, epilepsy, or brain injuries; or those who have experienced acute cardiovascular or cerebrovascular events, bone fractures, undergone hip or knee joint replacement, or present with lower limb balance impairments or structural injuries-such as amputations, post-lumbar surgery status, or acute ankle sprains-rendering participation unsuitable within the past six months.
- •Concurrent participation in other research studies during the study period, where the intervention may potentially influence the primary or secondary outcomes of this study.
- •Individuals who are legally declared under guardianship.
研究组 & 干预措施
Interventional arm
干预措施: Video game-facilitated group activity (Behavioral)
Controlled arm
结局指标
主要结局
The changes of quality of life
时间窗: The outcome will be assessed at baseline, week 12, and week 24.
The changes of quality of life will be assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
The changes of social function.
时间窗: The outcome will be assessed at baseline, week 12, and week 24
The changes of social function will be evaluated by the Personal and Social Performance Scale (PSP).
次要结局
- The changes of cerebral blood flow.(The outcome will be assessed at baseline and week 12.)
- The change of cognitive function.(The outcome will be assessed at baseline and week 12.)
- The change of psychiatric symptoms.(The outcome will be assessed at baseline and week 12.)
- The change of physical fitness(The outcome will be assessed at baseline and week 12.)
研究者
Wei-Yu Chiang
Resident psychiatrist
TsaoTun Psychiatric Center, Department of Health, Taiwan