Evaluating the implementation and effectiveness of a digital mental health intervention for psychiatric outpatient care in Canada and Brazil

Background: The COVID-19 pandemic led to increased rates of depression and anxiety and inequalities in the delivery of psychiatric outpatient services on a global scale. Digital mental health interventions (DMHIs) address this service gap by increasing access to care through mobile apps. Remote measurement-based care (RMBC) is an effective DMHI that monitors symptoms using clinical measures and/or patient sensor data in the real world. However, barriers to DMHI implementation persist and there is limited evidence evaluating DMHI effectiveness in diverse sociocultural contexts. Method: This clinical trial will examine the implementation and effectiveness of the Digital Intervention & Intelligence Group (DiiG) app in Canadian and Brazilian psychiatric outpatient settings. The DiiG app monitors weekly self-reports (depression, anxiety, well-being) and continuous sensor recordings. A user-informed approach will refine the DiiG app to meet the needs of marginalized populations. Patients (n = 100 per site) with major depressive disorder and/or anxiety disorders will participate in a single-arm implementation-effectiveness trial with follow-up at 6-months. Clinicians (n = 10 per site) will engage in pre-/post-implementation interviews exploring their experiences with DiiG implementation. Objectives: 1) Evaluate the DiiG implementation process in marginalized populations. 2) Assess the impact of DiiG on mental health outcomes and COVID-19 impact. 3) Explore DiiG implementation and effectiveness across sociocultural contexts. Predictions: DiiG will be positively received, with a high trial completion rate. Improvements will be seen over 6-months in mental health outcomes and COVID-19 impact, with high satisfaction in care. Impact: This research will generate new evidence informing DMHI implementation in diverse sociocultural contexts, critical for clinical decision-making and policy changes in Canadian and global mental health care in post-pandemic contexts.