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The investigators aim to establish a research project to test the impact of gaming by carrying out a video gaming interventions, monitoring its cognitive and clinical outcomes, while concurrently performing a multimodal brain imaging experiment.
The effectiveness of the gaming intervention will be assessed using a controlled, single-blind clinical trial with a pragmatic, three-arm parallel-group design.
Interventions: Three groups will be used; two intervention groups (N=48, each) and one active control group (N=48). Both games that will be used in intervention groups are likely to yield improvement in a wide spectrum of cognitive abilities, such as memory, visual-spatial ability, attention, tracking, decision making, and strategic skills, and activate reward systems of the brain that drive brain plasticity. The data collection, subject recruitment and training will be carried out in an outpatient psychiatric unit at Castle Peak Hospital. The study is aimed for patients' diagnoses of schizophrenia.
Recruitment: The health service's medical records at the study site will be screened by the authority of the chief medical doctor of the organisation. Patients will be screened to determine their eligibility for study participation. Eligible participants will be asked about their interest to participate in the study. If an eligible participant demonstrates interest in participating in the study, after signing two informed consent forms, baseline data with background information, intelligence quotient (IQ), medication dosage (chlorpromazine equivalence) will be collected. Recruitment will continue until the required sample size has been obtained.
Randomisation: Patients will be randomly assigned to one of the three parallel groups in blocks of six consecutive patients and a 1:1:1 ratio. After baseline data collection, the trial manager will be informed about the potential participants (by email, text message, or telephone call), and the trial manager will then allocate the patient to one of the three arms of the trial.
Power analysis and sample size: First, the sample size calculation is based both on a prior cognitive-efficacy meta-analysis for patients with schizophrenia showing an overall effect size (ES, Cohen's d) of 0.58 on verbal working memory. The statistical analysis for the primary endpoint will be performed with repeated measures using ANOVA (three intervention groups with pre- and post-intervention measurements) where the investigators hypothesis will be specifically tested by the within-between interaction. With a statistical power of 0.8 and α= 0.05, the investigators require at least 144 subjects (48 per group, calculated using G*Power 126.96.36.199). Based on a meta-analysis, the mean sample size is 50. Assuming a participation rate of 80% and completion rate of 72%, a total of 252 subjects (~84 per group) will be approached.
Second, for neuroimaging assessment, the total size of the study group will be 75 (25/a group), which is about 50% of our total sample (N=144). Patients for neuroimaging study will be randomized at baseline from the total sample. Randomization will be done based on a list of computer generated random numbers (done by a statistician out of the study group). The patients will participate in neuroimaging assessment prior to the intervention (pre-training, 25/a group) and after the intervention period (post-training, 25/a group). The investigators will assume 20% drop-out between baseline and follow-up assessment, which leave us with 20 patients/a group (N=60).
To verify whether the gaming interventions has been delivered as designed (intervention fidelity), patients' gaming logs will be analysed (gaming frequency [number of gaming sessions per week], the length of each session [minutes], a number of drop-outs). Further, patients gaming diaries including qualitative data will be analysed and linked with fidelity information and focus-group interviews (10 in each intervention group), to describe the strengths and possible limitations of the gaming interventions.
Overwatch (Blizzard Entertainment), Project:Neural, SimCity
Not yet recruiting
The Hong Kong Polytechnic University
Published on BioPortfolio: 2017-05-01T10:22:49-0400
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