"HEAL Together": A randomized, hybrid Type 1 effectiveness-implementation trial protocol of a peer-delivered behavioral activation intervention to improve methadone treatment retention

Jessica F Magidson^1*Valerie D Bradley¹Jessica Anane¹Mary B Kleinman¹Julia W Felton²Abigail C Hines¹Rithika Baskar¹Aaron D Greenblatt³Dwayne Dean¹Morgan Anvari¹Heather Fitzsimons³Melanie E Bennett³Annabelle (Mimi) Belcher³

• ¹University of Maryland, College Park, College Park, United States
• ²Henry Ford Health System, Detroit, United States
• ³University of Maryland Baltimore, Baltimore, United States

Background: Although medications exist to effectively treat opioid use disorder (OUD), treatment retention is a pressing challenge. Peer recovery specialists (PRSs) may play an important role in OUD treatment retention, yet few evidence-based interventions to support OUD retention have been developed specifically for PRS delivery. Behavioral activation is a brief, reinforcement-based intervention with empirical support for improving depression and substance use outcomes, delivered typically by specialist mental health providers. Informed by key stakeholder feedback, our team adapted a behavioral activation and problem-solving intervention for PRS delivery ("Peer Activate") to improve methadone treatment retention. Building on a successful open-label pilot trial demonstrating initial feasibility, acceptability, and preliminary effectiveness of Peer Activate, the current type 1 hybrid randomized controlled trial evaluates the effectiveness of Peer Activate compared to treatment as usual on six-month methadone retention (primary) and longer-term implementation outcomes. Methods: The trial is being conducted at a large methadone treatment program in Baltimore City, Maryland. We are enrolling 200 patients who recently initiated methadone treatment or are experiencing challenges with methadone adherence in a randomized 1:1 ratio to receive Peer Activate plus treatment as usual (PA+TAU) or TAU only. Additionally, we are recruiting 12 stakeholders to provide feedback on implementation and sustainability. Peer Activate consists of four core intervention sessions delivered by a PRS with relevant lived experience and training in the intervention. Sessions focus on problem-solving barriers to retention and behavioral activation-increasing value-driven, substance-free activities-and continued skill practice and relapse prevention. Assessments are administered at baseline, post-treatment (approximately three months), and six months. The primary effectiveness outcome is methadone retention over six months, measured using chart review. Implementation outcomes are defined based on Proctor's model, including feasibility, acceptability, and fidelity of the intervention.Discussion: This trial will provide insight as to whether a PRS-delivered intervention may be effective and feasible for improving methadone treatment retention and other behavioral health outcomes. If findings are promising, Peer Activate may provide a platform on which to incorporate an evidence-based behavioral activation approach into PRS training nationally.