A Digital System (YouXin) to Facilitate Self-Management by People With Psychosis in China: Protocol for a Nonrandomized Validity and Feasibility Study With a Mixed Methods Design (Preprint)

BACKGROUND Psychosis is one of the most disabling mental health conditions and causes significant personal, social, and economic burden. Accurate and timely symptom monitoring is critical to offering prompt and time-sensitive clinical services. Digital health is a promising solution for the barriers encountered by conventional symptom monitoring approaches, including accessibility, the ecological validity of assessments, and recall bias. However, to date, there has been no digital health technology developed to support self-management for people with psychosis in China. OBJECTIVE We report the study protocol to evaluate the validity, feasibility, acceptability, usability, and safety of a symptom self-monitoring smartphone app (YouXin; Chinese name 佑心) for people with psychosis in China. METHODS This is a nonrandomized validity and feasibility study with a mixed methods design. The study was approved by the University of Manchester and Beijing Anding Hospital Research Ethics Committee. YouXin is a smartphone app designed to facilitate symptom self-monitoring for people with psychosis. YouXin has 2 core functions: active monitoring of symptoms (ie, smartphone survey) and passive monitoring of behavioral activity (ie, passive data collection via embedded smartphone sensors). The development process of YouXin utilized a systematic coproduction approach. A series of coproduction consultation meetings was conducted by the principal researcher with service users and clinicians to maximize the usability and acceptability of the app for end users. Participants with psychosis aged 16 years to 65 years were recruited from Beijing Anding Hospital, Beijing, China. All participants were invited to use the YouXin app to self-monitor symptoms for 4 weeks. At the end of the 4-week follow-up, we invited participants to take part in a qualitative interview to explore the acceptability of the app and trial procedures postintervention. RESULTS Recruitment to the study was initiated in August 2022. Of the 47 participants who were approached for the study from August 2022 to October 2022, 41 participants agreed to take part in the study. We excluded 1 of the 41 participants for not meeting the inclusion criteria, leaving a total of 40 participants who began the study. As of December 2022, 40 participants had completed the study, and the recruitment was complete. CONCLUSIONS This study is the first to develop and test a symptom self-monitoring app specifically designed for people with psychosis in China. If the study shows the feasibility of YouXin, a potential future direction is to integrate the app into clinical workflows to facilitate digital mental health care for people with psychosis in China. This study will inform improvements to the app, trial procedures, and implementation strategies with this population. Moreover, the findings of this trial could lead to optimization of digital health technologies designed for people with psychosis in China. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/45170