BACKGROUND 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. OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS “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. CLINICALTRIAL https://www.drks.de/search/de/trial/DRKS00030852/details INTERNATIONAL REGISTERED REPORT RR2-10.2196/46651
Kerber et al. (Wed,) studied this question.