The impact of gaming on functioning among people with schizophrenia: study protocol for a randomised controlled trial...

Gaming interventions hold promising potential for methods of mental health treatment. Games designed for individuals with serious mental illness have demonstrated high acceptability. They have been shown to improve treatment engagement and increase a sense of self-efficacy and social integration. However, concerns remain over the potential adverse effects of regular gaming. Therefore, to investigate both the benefits and the risks, there is a need for well-designed, -conducted and -reported high-quality trials. This study aims to evaluate the effectiveness of a gaming intervention in improving functional and clinical outcomes in people with psychotic disorders and to assess the feasibility of the intervention.

The effectiveness of the gaming intervention will be assessed using a controlled clinical trial with a pragmatic, multicentre, two-arm parallel-group design. The participants will be recruited from various types of outpatient units (e.g. outpatient psychiatric units, day hospitals, residential care homes). Following the baseline assessment, participants will be centrally randomised (1:1) to receive either the gaming intervention plus treatment as usual (TAU) or TAU alone. The primary outcome will be the change in social functioning, measured at 3- and 6-month follow-ups. The secondary outcomes will include the patients' major psychiatric symptoms, self-efficacy, quality of life, and aggression and potential adverse effects, also measured at 3 and 6 months. We will also test the feasibility of the gaming intervention from the perspectives of patients and nursing staff at a 3-month follow-up. Data will be collected from outpatient psychiatric services across Finland. Eligible participants will be between 18 and 60 years old and have a formal diagnosis of a psychotic disorder (F20-F29). We aim to recruit a total of 356 participants (178 for each group). We will estimate the efficacy of the intervention on the primary and secondary outcomes based on the intention-to-treat principle. Feasibility data will be analysed separately.

This study will be one of the first trials to address the effectiveness of video gaming on improving functional and clinical outcomes in people with schizophrenia. The study will offer new information to confirm both the benefits and possible disadvantages of using gaming to improve patients' health and well-being as new approaches to patient care in mental health services in Finland are explored. The results may provide insight into treatment for other health conditions in which motivational problems impact health outcomes.

NCT05707689 . Registered on 21 January 2023.