Protocol of the Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS): a Multiphase Optimization Strategy (MOST) study implementing a gamified mHealth intervention to reduce postdischarge suicide risk in patients with mental disorders in Shenzhen.

introductionPostdischarge suicide risk among psychiatric patients is a great concern. Gamified interventions have demonstrated promise in reducing the risk. This study aims to reduce postdischarge suicide risk through a mHealth intervention that engages and supports patients through gamified features. Built on our previous research, this study will develop, optimise and evaluate a gamified intervention under the Multi-phase Optimization Strategy (MOST) framework in implementation science. METHODS AND ANALYSIS: This study will be conducted at the Shenzhen Kangning Hospital. Following the MOST framework, we will develop the gamified mHealth app (Tailored Evidence-based Enhancements in Mental Health (TEEM)) with four intervention components in the selection phase. In the optimisation phase, a factorial design randomised controlled trial (RCT) will be conducted to identify the optimised configuration. A total of 320 patients with mental disorders will be recruited and randomised into 16 groups to receive TEEM with different combinations of intervention components, with follow-ups scheduled at 1 week, 1 month, 2 months and 3 months after discharge. In the confirmation phase, we will assess the optimised TEEM through a standard RCT, comparing it to usual care. An additional 320 patients with mental disorders will be recruited for this phase, and the follow-up schedule is the same as in the optimisation phase. Psychiatric patients and family members, clinical and community mental health service providers will be recruited as the community team to help develop and evaluate the TEEM. Quantitative data will be analysed using the intention-to-treat approach and generalised estimating equations, and qualitative data will be coded and categorised to identify key themes. ETHICS/DISSEMINATION: The Ethics Committee Review Board of Shenzhen Kangning Hospital has approved this study. All participants will provide written informed consent prior to enrolment. The findings will be disseminated through peer-reviewed scientific journals and conference presentations, and a report will be submitted to the National Natural Science Foundation of China and the mental health authorities in the Shenzhen Municipal Health Commission. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, ID: NCT06358339.