Supporting Treatment Access and Recovery in COD
- Conditions
- Opioid Use DisorderMental Health Disorder
- Interventions
- Other: Medication for Opioid Use DisorderBehavioral: MISSION Critical Time InterventionBehavioral: MISSION Peer SupportBehavioral: MISSION Dual Recovery Therapy
- Registration Number
- NCT05138614
- Lead Sponsor
- University of Massachusetts, Worcester
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Full MISSION MISSION Peer Support CTI + DRT + PS + MOUD CTI & DRT MISSION Dual Recovery Therapy CTI + DRT + MOUD CTI & PS MISSION Peer Support CTI + PS + MOUD Full MISSION MISSION Critical Time Intervention CTI + DRT + PS + MOUD Full MISSION MISSION Dual Recovery Therapy CTI + DRT + PS + MOUD CTI & DRT Medication for Opioid Use Disorder CTI + DRT + MOUD CTI & DRT MISSION Critical Time Intervention CTI + DRT + MOUD Full MISSION Medication for Opioid Use Disorder CTI + DRT + PS + MOUD CTI & PS MISSION Critical Time Intervention CTI + PS + MOUD DRT & PS Medication for Opioid Use Disorder DRT + PS + MOUD DRT & PS MISSION Peer Support DRT + PS + MOUD DRT & PS MISSION Dual Recovery Therapy DRT + PS + MOUD CTI & PS Medication for Opioid Use Disorder CTI + PS + MOUD MOUD only Medication for Opioid Use Disorder MOUD
- Primary Outcome Measures
Name Time Method Opioid use and other substance use (drug screen) 6 months Measured by positive drug screens
PTSD symptoms 12 months Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental health impairment 12 months Measured by self-report on WHODAS 2.0
Self-report opioid use and other substance use 12 months Measured by self-report days of use
Medication Adherence 6 months Measured by Medication Adherence Rating Scale
Engagement in treatment 6 months Measured by total days in treatment
Engagement in outreach and linkage sessions 6 months Measured by total number of outreach and linkage sessions
Suicide Severity 12 months Measured by C-SSRS
Recovery Capital 12 months Measured by Assessment of Recovery Capital
Engagement in medication for opioid use disorder (MOUD) 6 months Measured by percentage of days receiving MOUD
Psychiatric severity Baseline Measured by Structured Clinical Interview for DSM-5 (SCID-RV)
Motivation for treatment 12 months Measured by SOCRATES
Therapeutic alliance 12 months Measured by Working Alliance Inventory
Mental health functioning 12 months Measured by self-report mental health symptoms on BASIS-24
Health functioning 12 months Measured by the WHOQOL-BREF
Chronic pain 12 months Measured by Chronic Pain assessment
Overall well-being 6 months Measured by EQ-5D-5L
- Secondary Outcome Measures
Name Time Method Mortality 6 months Data extracted from medical records
Trial Locations
- Locations (3)
SaVida Health
🇺🇸Worcester, Massachusetts, United States
UMass Chan Road to Care Clinic
🇺🇸Worcester, Massachusetts, United States
Behavioral Health Network
🇺🇸Springfield, Massachusetts, United States