Improving Mild to Moderate Depression With an App-Based Self-Guided Intervention: Protocol for a Randomized Controlled Trial

Background: Depression is one of the most prevalent mental disorders and frequently co-occurs with other mental disorders. Despite the high direct and indirect costs to both individuals and society, more than 80% of those diagnosed with depression remain with their primary care physician and do not receive specialized treatment. Self-guided digital interventions have been shown to improve depression and, due to their scalability, have a large potential public health impact. Current digital interventions often focus on specific disorders, while recent research suggests that transdiagnostic approaches are more suitable. Objective: This paper presents the protocol for a study that aims to assess the efficacy of a self-guided transdiagnostic app-based self-management intervention in patients with mild or moderate depression with and without comorbid mental disorders. Specifically, we are investigating the impact of the intervention on symptoms of depression, quality of life, anxiety symptoms, and mental health–related patient empowerment and self-management skills. Methods: The intervention under investigation, MindDoc with Prescription, is a self-guided digital intervention aimed at supporting individuals with mild to moderate mental disorders from the internalizing spectrum, including depression. The app can be used as a low-threshold psychosocial intervention. Up to 570 adult patients will be randomized to either receive the intervention in addition to care as usual or only care as usual. We are including adults with a permanent residency in Germany and mild or moderate depression according to International Classification of Diseases, 10th Revision, criteria (F32.0, F32.1, F33.0, and F33.1). Clinical interviews will be conducted to confirm the diagnosis. Data will be collected at baseline as well as 8 weeks and 6 months after randomization. The primary outcome will be depression symptom severity after 8 weeks. Secondary outcomes will be quality of life, anxiety symptom severity, and patient empowerment and self-management behaviors. Data will be analyzed using multiple imputations, using the intention-to-treat principle, while sensitivity analyses will be based on additional imputation strategies and a per-protocol analysis. Results: Recruitment for the trial started on February 7, 2023, and the first participant was randomized on February 14, 2023. As of September 5, 2023, 275 participants have been included in the trial and 176 have provided the primary outcome. The rate of missing values in the primary outcome is approximately 20%. Conclusions: Data from this efficacy trial will be used to establish whether access to the intervention is associated with an improvement in depression symptoms in individuals diagnosed with mild or moderate depression. The study will contribute to expanding the evidence base on transdiagnostic digital interventions. Trial Registration: German Registry of Clinical Trials DRKS00030852; https://drks.de/search/de/trial/DRKS0003085