Development of a supportive mHealth device for persons with schizophrenia spectrum disorders (KisoLightApp): a usability study within a participant-involvement principle.

Background: To address the severe treatment gap in persons with schizophrenia spectrum disorders (SSD), this study aims to examine the usability of and satisfaction with a novel and initial mHealth application (KisoLightApp) for SSD in Germany. The app is designed as a stand-alone tool that offers specific features such as symptom monitoring, medication adherence, and activity planning. Method: Within a single-arm usability trial, N = 19 participants engaged with the app over 2 weeks and completed baseline and post-engagement assessments. Quantitative and qualitative measures were included to assess feedback for the continuous development of the KisoApp. Results: The majority of participants engaged with the app regularly (n = 17 [89.50%], multiple times per week or daily). Descriptive results indicate a high usability and satisfaction with the app. Although a few unserious unwanted events (UEs) were reported, there were no serious UEs or adverse treatment reactions (ATR), indicating the safety of the app. Conclusion: The KisoLightApp for persons with SSD seem to be a safe, usable, and satisfying tool for supporting the addressed population. Future studies should examine an enhanced version of the app within a randomized controlled trial, including a larger sample size and additional therapeutic features.