The Impact of Video Gaming on Cognitive Functioning in People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 9
- 主要终点
- Verbal working memory function at 3-month and 6-month follow-ups
研究概览
简要总结
The investigators aim to establish a research project to test the impact of gaming by carrying out a digital gaming interventions, monitoring its cognitive and clinical outcomes, while concurrently performing a multimodal brain imaging experiment.
详细描述
The effectiveness of the gaming intervention will be assessed using a controlled, controlled, single-blind clinical trial with a pragmatic, three-arm parallel-group design.
Interventions: Participants will be randomised into three groups: Cognitive training (intervention group, CogniFit, N=78), entertainment video gaming (active control group, SIMS4, N=78) and treatment as usual (a passive control group, N=78). The mechanism of CogniFit (intervention) lies on the evidence for computerised exercises focusing on auditory and verbal processing, which are likely to yield improved verbal learning and memory and activate reward systems of the brain that drive brain plasticity in adults with schizophrenia. SIMS4 game (active control) offers entertainment without any known cognitive or health-related outcome. The data collection, subject recruitment and training will be carried out in an outpatient psychiatric units or outpatient clinics, mental health associations, and residential homes in Hong Kong. The study is aimed for patients' diagnoses of schizophrenia.
Recruitment: An extended informed consent process will be used. The health service's medical records at the study site will be screened by the authority of the staff of the organisation. Patients will be screened to determine their eligibility for study participation. Eligible participant will first receive a short leaflet of the study from the staff or during a short information session organised for the participants to consider their availability. If an eligible patient shows interest, more detailed written and oral information will be shared.
After signing informed consent forms (two identical copies), baseline data with background information, Intelligence Quotient (IQ, if available) and MMSE will be collected to show evidence of the participants' capacity to give informed consent. Medication dosage [chlorpromazine equivalence] will be collected as some medications currently used in schizophrenia may affect the response to cognitive training strategies.
Recruitment will continue until the required sample size has been obtained.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The sequences of allocation will be concealed until interventions will be assigned. Allocation will not be masked to the researchers, who will recruit patients. Outcome assessors (who will not participate in patient randomisation or daily clinical treatment at the same unit) will be masked. The data analyst (the trial statistician) will be kept blinded to the allocation. Allocation: Randomized The trial manager will allocate the patient to one of the three arms of the trial based on a list of computer-generated random numbers (provided by an external clinical trial randomisation service).
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Verbal working memory function at 3-month and 6-month follow-ups
时间窗: 3-month and 6-month follow-ups
Measured by Letter-number-span task from Wechsler Memory Scale III (WMS III), simplified/traditional Chinese versions. The instrument includes the National Institute of Mental Health - Measurement and Treatment Research to Improve Cognition in Schizophrenia 50 battery (NIMH-MATRICS50).
次要结局
- Psychotic symptoms(Baseline, after intervention (three months) and at six months follow-up)
- Anhedonia symptoms(Baseline, after intervention (three months) and at six months follow-up)
- Avolition symptoms(Baseline, after intervention (three months) and at six months follow-up)
- Neurocognition: the impact of gaming on brain functional networks (EEG/rsfMRI)(Baseline, after intervention (three months))
- Neurocognition: the impact of gaming on changes in neuronal dynamics (EEG/rsfMRI)(Baseline, after intervention (three months))
- Neurocognition: the impact of gaming on brain functional networks (EEG/Structural magnetic resonance imaging)(Baseline, after intervention (three months))
- Neurocognition: the impact of gaming on changes in neuronal dynamics (EEG/Structural magnetic resonance imaging)(Baseline, after intervention (three months))
- Cognitive functioning: vigilance(Baseline, after intervention (three months) and at six months follow-up)
- Cognitive functioning: speed of processing(Baseline, after intervention (three months) and at six months follow-up)
- Cognitive functioning: attention(Baseline, after intervention (three months) and at six months follow-up)
- Social functioning: severity of social phobia(Baseline, after intervention (three months) and at six months follow-up)
- Social functioning: treatment response in social phobia(Baseline, after intervention (three months) and at six months follow-up)
- Cognitive functioning: visuo-spatial working memory(Baseline, after intervention (three months) and at six months follow-up)
- Cognitive functioning: reasoning(Baseline, after intervention (three months) and at six months follow-up)
- Cognitive functioning: problem solving(Baseline, after intervention (three months) and at six months follow-up)
- Experience of pleasure: anticipatory component(Baseline, after intervention (three months) and at six months follow-up)
- Experience of pleasure: consummatory component(Baseline, after intervention (three months) and at six months follow-up)
- Self-efficacy(Baseline, after intervention (three months) and at six months follow-up)
研究者
Maritta Anneli Välimäki
Professor
The Hong Kong Polytechnic University