Effectiveness, Effectiveness, Empowerment and Real World Usage: A Randomized Controlled Trial of a Mobile Prescription App for Depression within the German Healthcare System (Preprint)

<sec> <title>BACKGROUND</title> Depression is a common mental health issue, while treatment access and utilization are limited. Digital interventions, including prescribable Digital Health Applications (DiGAs), offer scalable solutions for various health conditions, providing users with self-management tools, often based on evidence-based approaches like cognitive-behavioral therapy, to address specific health needs, ranging from mental health to chronic diseases. </sec> <sec> <title>OBJECTIVE</title> This study aims to evaluate the effectiveness of "MindDoc auf Rezept" (MindDoc with Prescription) against a waitlist control group receiving treatment as usual in several key areas: reducing symptoms of depression and anxiety, improving overall quality of life, and fostering mental health-related patient empowerment and self-management abilities. </sec> <sec> <title>METHODS</title> A two-arm randomized controlled trial was conducted with 571 participants diagnosed with mild or moderate depression. Participants were randomized to the intervention group (unguided access to "MindDoc auf Rezept") or a waitlist control group. Participants were recruited online and self-assessments were conducted at baseline, 8 weeks (post-intervention), and 6 months (follow-up). The primary outcome was depression symptom severity (PHQ-9) after 8 weeks. Secondary outcomes included anxiety symptoms (GAD-7), quality of life (AQoL-8D), and mental health-related patient empowerment and self-management skills (AMHPSS). Furthermore, app usage patterns among both study participants and 478 real-world prescription users were examined. </sec> <sec> <title>RESULTS</title> Study dropout was 18.4% after 8 weeks with lower baseline personality functioning being a significant predictor. At 8 weeks, the intervention group showed significantly less severe depression symptoms than the control group (Cohen's d = 0.27). Significant group effects were also observed for anxiety symptoms and mental health-related patient empowerment and self-management skills. Subgroup analyses indicated that individuals with higher baseline patient empowerment benefited more. Study participants (94% downloaded and used the app) accessed the app on 75% of days within the first 8 weeks, with retention rates at 15, 30 and 90 days of 93.9%, 89.8% and 62.5%. Real-world users accessed the app on 55% of days within 8 weeks, with retention rates at 15, 30 and 90 days at 87.4%, 78.4% and 52.1%. No significant differences in serious adverse events were observed between groups. Negative occurrences (INEP) were reported significantly more frequently by the control group. </sec> <sec> <title>CONCLUSIONS</title> “MindDoc auf Rezept" is an effective and safe intervention for mild to moderate depression, leading to significant symptom reduction, and enhanced patient empowerment and self-management skills. It offers a scalable, low-threshold approach to improving mental well-being within the German healthcare system. </sec> <sec> <title>CLINICALTRIAL</title> https://www.drks.de/search/de/trial/DRKS00030852/details </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> RR2-10.2196/46651 </sec>