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

Abstract

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% remain with their primary care physician and don’t receive specialized treatment. Unguided 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 The study aims to assess the efficacy of an unguided transdiagnostic app-based self-management intervention in patients with mild or moderate depression with and without comorbid mental disorders. METHODS Approximately 570 patients with mild or moderate depression will be randomized to receive the intervention in addition to care as usual, or care as usual only. Data will be collected at baseline as well as 8 weeks and 6 months after randomisation. The primary outcome will be depression symptom severity after 8 weeks. Secondary outcomes will be quality of life, anxiety symptom severity, and patient sovereignty and self-management behaviors. Data will be analyzed using multiple imputation, employing 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, 7th, 2023, the first participant was randomized on February, 14th, 2023. CONCLUSIONS Data from this efficacy trial will be used to establish whether access to the intervention is associated with an improvement of depression symptoms in individuals diagnosed with mild or moderate depression. The study will contribute to the evidence base on transdiagnostic digital interventions. CLINICALTRIAL The trial has been registered in the DRKS trial register (DRKS00030852); Pre-results.