nctId: NCT06358339 id: 72374095 briefTitle: TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-08-31 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Shenzhen Kangning Hospital class: OTHER briefSummary: Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, feasibility, and sustainability of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: After recruitment and the baseline survey, participants will be assigned into Group 1 to Group 16 by simple randomization in R program. The allocation ratio in randomization will be 1:1. Participants, LHSs, nurses who perform recruitment and baseline survey, and investigators who perform follow-ups will be blinded to the assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 640 type: ESTIMATED name: TEEM measure: Suicide ideation at three months after discharge measure: The rate of re-visits to outpatient clinic at three months after discharge measure: Self-determination at at three months after discharge measure: Social connectedness at three month after discharge measure: Social support at three months after discharge measure: Times of re-hospitalization for mental disorders measure: Attitudes towards the acceptability of the intervention measure: Attitudes towards the adoption of the intervention measure: The adoption rate of the intervention in patients measure: Attitudes towards the equity of the intervention measure: Attitudes towards the feasibility of the intervention measure: Attitudes towards the patient-centeredness of the intervention measure: Cost for implementing the TEEM-GIFTS measure: Fidelity of the study measure: Efficiency of the intervention measure: Attitudes towards the safety of the intervention measure: The timeliness of the intervention measure: Patients' perceived stigma from baseline to three months after discharge measure: Patients' self-efficacy from baseline to three months after discharge measure: Patients' compliance to treatment from baseline to three months after discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shenzhen Kangning Hospital city: Shenzhen state: Guangdong zip: 518020 country: China lat: 22.54554 lon: 114.0683 hasResults: False