Hybrid Type-1 Effectiveness-implementation Trial for Primary Care Depression Screening and Referral to a Remote Digital Mental Health Clinic

The goal of this study is to test the MHP as a 'package solution' of screening and treatment in a primary care setting through a 2-step clinical trial process: (1) A smaller proof-of-concept (POC) trial to provide guidance and establish the settings and assessments for (2) A larger confirmatory type 1 hybrid effectiveness Randomized Controlled Trial (RCT) followed by the collection of potential facilitators and barriers to the treatment's wide scale implementation.

The POC study is aimed to develop all of the study materials for the RCT, and test the screening, referral, and study enrollment procedures. 30 participants will be recruited from 1 primary care clinic. The first 15 eligible participants will be referred to TAU, while the second 15 eligible participants will be referred to the MHP. Study assessments will be performed at the baseline (prior to treatment), 6-week, and 12- week (EOT) time points. In addition, at the end of the 12- week study period, we will interview the participants and providers about their experiences with the study to inform the eventual trial. Feedback will be incorporated into improved study methods.

The 300 participant RCT will be used to demonstrate long lasting and significant improvements of the MHP on participants, measured by a set of assessments completed 6 times for each enrolled participant. Study assessments will be performed at the baseline (prior to treatment), 6-, and 12 weeks (EOT) after baseline, as well as 1-, 3-, 6- and 12-month follow-up time points. Using a stepped-wedge randomization study design, 150 participants will be assigned to MHP and 150 to TAU. Participants with a screening PHQ-9 of 10+ will be randomly assigned to MHP or TAU. For TAU participants, primary care providers will not be directed on how to manage the case, while participants in the MHP group will be scheduled into groups of 10-15 individuals who will work through the program together. Participants will receive the Heart Rate Variability Biofeedback (HRV-B) device and be directed to download and follow the MHP app which prompts daily practices and chat communication. Study assessments for both groups will be administered online with response as the primary outcome.

Lastly will be a multistakeholder process evaluation of the delivery of the MHP intervention. Data collected from the 300 RCT participants, as well as administrators and providers from the 8 primary care clinics, will be evaluated for completion rates, engagement metrics, and satisfaction using multiple factors. We will then evaluate the program through surveys and interviews and examine patterns of mental health treatment utilization during the 12-week period, intervention fidelity and competence, attitudes, competencies, and barriers and facilitators of implementation of the MHP.