The Impact of Gaming on Functioning Among People With Schizophrenia: a Randomised Controlled Trial (GAME-A)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Functioning
研究概览
简要总结
The goal of this clinical trial is to test whether gaming intervention works well for persons with psychotic disorder. The main question to be answered is whether gaming works well in improving functioning, some other clinical outcomes or causing any adverse effects. Researchers will compare gaming group to usual care.
详细描述
The overall goal of this study is to evaluate the effectiveness of gaming to improve functioning and clinical outcomes in people with psychotic disorders. Feasibility of the intervention will also be assessed. Our hypothesis are as follows:
Primary hypothesis:
- Gaming is more effective on improving functioning 3- and/or 6-months follow-ups comparing to usual practices (TAU).
Secondary hypotheses: 2. Gaming is more effective on improving clinical outcomes and treatment acceptance (symptoms, self-efficacy, the quality of life, drop-out from intervention) at 3-and/or 6-months comparing to usual practices (TAU). 3. Gaming do not cause more adverse effects up to 6 months, especially aggression at 3-and/or 6-months follow-ups comparing to usual practices (TAU).
The effectiveness of the gaming will be assessed using a controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design. Feasibility will also be assessed.
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
- Single (Investigator)
盲法说明
Statisticians will be masked. Gaming facilitators, research assistant who collect the data or staff working in the study sites are not masked.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Finnish speaking
- •A formal diagnosis of psychotic disorders (F20-F29, ICD-10; to be identified in medical records or other reliable sources by staff)
- •Age between 18 and 60 years old
- •Ability to participate in the study based on their own free will
- •Ability to provide written informed consent
排除标准
- •Clinical diagnostic criteria for a current major depressive, manic or hypomanic episode or mental retardation (ICD-10)
- •Severe visual impairment
- •Signs or diagnosis of gaming addiction
- •Lack of ability to decide one's own participation (under guardianship)
- •Substance abuse (other than nicotine dependence)
- •Head injury, hemiplegia, or other neurological disorder
- •Electroconvulsive therapy (ECT) in the past six months
研究组 & 干预措施
Gaming
Gaming intervention with entertainment video games will be run in small groups (6-10 players) closely monitored by trained gaming facilitators. Pre-scheduled gaming sessions, about 60 minutes each, will be run twice a week over 10 weeks (totally 20 hours).
干预措施: Entertainment gaming (Behavioral)
Treatment as usual (TAU)
Participants will join usual practices as planned in community services. No specific activities will be organized to them by the research team.
结局指标
主要结局
Functioning
时间窗: Day 0, Month 3, Month 6
The change in functioning will be assessed with the Personal and Social Performance Scale. The instrument includes four domains: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. Difficulty in each area is rated on a single item using a six-point scale (absent, mild, manifest but not marked, marked, severe, or very severe). A global item will be rated by the nurse, ranging from 1 to 100 in ten-point intervals: lower scores indicate poorer functioning.
次要结局
- Major symptoms of mental health(Day 0, Month 3, Month 6)
- Engagement with the intervention(Through intervention completion, an average 3 months)
- Adverse effect: The number of hospitalisations(Through study completion, an average 6 months)
- Depressive symptoms(Day 0, Month 3, Month 6)
- Engagement with the study (%)(Through study completion, an average 6 months)
- Adverse effect: Relapse, a dosage increased(Through study completion, an average 6 months)
- Adverse effect: Symptoms(Through study completion, an average 6 months)
- Adverse effect: Admission into psychiatric hospital (yes/no)(Through study completion, an average 6 months)
- Adverse effect: The number of violent incidents(Through study completion, an average 6 months)
- Adverse effect: Self-harming(Through study completion, an average 6 months)
- Adverse effect: Death(Through study completion, an average 6 months)
- Self-efficacy(Day 0, Month 3, Month 6)
- The quality of life(Day 0, Month 3, Month 6)
- Adverse effect: Relapse, additional medicines prescribed(Through study completion, an average 6 months)
- Adverse effect: The number of hospital days(Through study completion, an average 6 months)
- Adverse effect: The number of self-harm incidents(Through study completion, an average 6 months)
- Adverse effect: Violent incidents(Through study completion, an average 6 months)
- Adverse effect: Aggression(Day 0, Month 3, Month 6)
研究者
Maritta Välimäki
Professor
University of Turku