The impact of video gaming on cognitive functioning of people with schizophrenia (GAME-S): study protocol of a randomised controlled trial.

Background Video gaming is a promising intervention for cognitive and social impairment in patients with schizophrenia. A number of gaming interventions have been evaluated in small-scale studies with various patient groups, but studies on patients with schizophrenia remain scarce and rarely include the evaluation of both clinical and neurocognitive outcomes. In this study, we will test the effectiveness of two interventions with gaming elements to improve cognitive and clinical outcomes among persons with schizophrenia. Methods The participants will be recruited from different outpatient units (e.g., outpatient psychiatric units, day hospitals, residential care homes). The controlled clinical trial will follow a three-arm parallel-group design: 1) cognitive training (experimental group, CogniFit), 2) entertainment gaming (active control group, SIMS 4), and 3) treatment as usual. The primary outcomes are working memory function at 3-month and 6-month follow-ups. The secondary outcomes are patients' other cognitive and social functioning, the ability to experience pleasure, self-efficacy, and negative symptoms at 3-month and 6-month follow-ups. We will also test the effectiveness of gaming interventions on neurocognitive outcomes (EEG and 3 T MRI plus rs-fMRI) at a 3-month follow-up as an additional secondary outcome. Data will be collected in outpatient psychiatric services in Hong Kong. Participants will have a formal diagnosis of schizophrenia and be between 18 and 60 years old. We aim to have a total of 234 participants, randomly allocated to the three arms. A sub-sample of patients (N = 150) will be recruited to undergo an EEG. For neuroimaging assessment, patients will be randomly allocated to a subset of patients (N=126). We will estimate the efficacy of the interventions on the primary and secondary outcomes based on the intention-to-treat principle. Behavioural and EEG data will be analysed separately. Discussion The study will characterise benefits of gaming on patients' health and well-being, and contribute towards the development of new treatment approaches for patients with schizophrenia. Trial registration ClinicalTrials.gov NCT03133143 . Registered on April 28, 2017.