Supporting Treatment Access and Recovery in COD (STAR-COD)

National Institute of Mental Health (NIMH), University of Massachusetts, Lowell, University of Texas at Austin, Harvard Medical School (HMS and HSDM)

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

This is a 4-year, 5-arm randomized control trial with a fractional factorial design among 1,000 patients across MOUD programs in Massachusetts. Patients will be randomized to: 1) MOUD alone; 2) full MISSION (CTI & DRT & PS) + MOUD; 3) CTI & DRT + MOUD; 4) PS & DRT + MOUD; or 5) CTI & PS + MOUD (Arms 3-5 are the 3 combinations of 2 MISSION parts). MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices along with MOUD: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. Participants will receive 6 months of treatment and be followed for 1-year. Study aims include: Aim 1: To evaluate the effectiveness of MISSION or its bundled parts with MOUD versus MOUD alone, as well as the incremental benefits of MISSION and its parts + MOUD to improve outcomes 1a-c for CODs. Hypothesis 1.1: Individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: 1a. Engagement (measured by total days in treatment, percentage of days receiving MOUD, and total number of outreach and linkages sessions); 1b. Opioid use and other substance use (measured by self-report days of use and drug screens); and 1c. Mental health (measured by self-report mental health symptoms). Hypothesis 1.2: MISSION + MOUD will outperform its parts + MOUD but at least one of the three combinations + MOUD will be at least 75% as effective compared to the full MISSION protocol on outcomes 1a-c. Aim 2: To examine mechanisms of action of MISSION in CODs. Hypothesis 2.1: The effects of MISSION and its bundled parts on health outcomes (mental health, opioid and other substance use) are mediated by treatment participation and other measures (e.g., recovery capital, psychosocial supports, and quality of life). Hypothesis 2.2: The effects of MISSION and its parts on health outcomes are moderated by key patient characteristics (e.g., demographics, severity of COD, and MOUD type). Aim 3: To conduct a comprehensive economic evaluation of MISSION or its bundled parts and MOUD. Estimate cost of full MISSION or its bundled parts compared to MOUD alone, and to evaluate cost-effectiveness and return on investment from multiple perspectives, including patient, clinic, healthcare, taxpayer, and societal. Exploratory Aim: 4. To construct a predictive model that can match optimum combined use of MISSION parts with specific patient's needs for greater improvements in health outcomes, which will inform a future randomized controlled trial on cost-effective patient-level precision intervention assignment.

MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices along with MOUD: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery

Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

Cost of full MISSION and MOUD measured by Patient-Reported Outcomes Measurement Information System-Preference (PROPr)

Inclusion Criteria: Are 18 years-old and older; Are fluent in English or Spanish; Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.; Able to provide consent; Potentially have a concurrent substance use disorder in addition to opioids; and Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for "a" (i.e., not having a substance use relapse), but they do meet criteria for "b" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria. Exclusion Criteria: Are not fluent in English or Spanish; Are acutely psychotic, acutely suicidal with a plan, or homicidal; Are incompetent and unable to provide informed consent; and Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of > 10 mg/day; Diazepam > 100 mg/day; Clonazepam 5 mg/ day; Alprazolam 5 mg/day.

Consistent with the NIH HEAL Initiative, Underlying Primary Data collected from participants in this project will be made readily available to the public through twice-yearly submissions to the NIMH Data Archive (NDA). In consultation with the University of Massachusetts Medical School's institutional review board (IRB), project consent forms will include relevant information for participants to be made aware that their de-identified data will be available to other investigators as a part of the HEAL Initiative Public Access and Data Sharing Policy.

Data will be available upon publication (via an NDA Study) or 1-2 years after the grant end date (Sept 2025), until 2032 (expiration of NDA Certificate of Confidentiality)