Treatment of Substance Use Disorders With a Mobile Phone App Within Rural Collaborative Care Management (Senyo Health): Protocol for a Mixed Methods Randomized Controlled Trial

BACKGROUND: COVID-19 worsened an already existing problem in substance use disorder (SUD) treatment. However, it helped transform the use of telehealth, which particularly benefits rural America. The lack of specialty addiction treatment in rural areas places the onus on primary care providers. Screening, brief intervention, and referral to treatment (SBIRT) is an evidenced-based strategy commonly used in primary care settings to target SUD outcomes and related behaviors. The integration of telehealth tools within the SBIRT pathway may better sustain the program in primary care. Building on Mayo Clinic's experience with collaborative care management (CoCM) for mental health treatment, we built a digitally native, integrated, behavioral health CoCM platform using a novel mobile app and web-based provider platform called Senyo Health. OBJECTIVE: This protocol describes a novel use of the SBIRT pathway using Senyo Health to complement existing CoCM integration within primary care to deliver SUD treatment to rural patients lacking other access. We hypothesize that this approach will improve SUD-related outcomes within rural primary care clinics. METHODS: Senyo Health is a digital tool to facilitate the use of SBIRT in primary care. It contains a web-based platform for clinician and staff use and a patient-facing mobile phone app. The app includes 16 learning modules along with data collection tools and a chat function for communicating directly with a licensed drug counselor. Beta-testing is currently underway to examine opportunities to improve Senyo Health prior to the start of the trial. We describe the development of Senyo Health and its therapeutic content and data collection instruments. We also describe our evaluation strategy including our measurement plan to assess implementation through a process guided by Consolidated Framework for Implementation Research methods and effectiveness through a waitlist control trial. A randomized controlled trial will occur where 30 participants are randomly assigned to immediately start the Senyo intervention compared to a waitlist control group of 30 participants who will start the active intervention after a 12-week delay. RESULTS: The Senyo Health app was launched in May 2023, and the most recent update was in August 2024. Our funding period began in September 2023 and will conclude in July 2027. This protocol defines a novel implementation strategy for leveraging a digitally native, clinical platform that enables the delivery of CoCM to target an SUD-specific patient population. Our trial will begin in June 2025. CONCLUSIONS: We present a theory of change and study design to assess the impact of a novel and patient-centered mobile app to support the SBIRT approach to SUD in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT06743282; http://clinicaltrials.gov/ct2/show/NCT06743282. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/65693.