Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- Engagement in treatment
研究概览
简要总结
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.
详细描述
This is a 5-arm randomized control trial with a fractional factorial design among 1,000 patients across 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Full MISSION
CTI + DRT + PS + MOUD
干预措施: MISSION Critical Time Intervention (Behavioral)
MOUD only
MOUD
干预措施: Medication for Opioid Use Disorder (Other)
DRT & PS
DRT + PS + MOUD
干预措施: Medication for Opioid Use Disorder (Other)
DRT & PS
DRT + PS + MOUD
干预措施: MISSION Peer Support (Behavioral)
DRT & PS
DRT + PS + MOUD
干预措施: MISSION Dual Recovery Therapy (Behavioral)
Full MISSION
CTI + DRT + PS + MOUD
干预措施: Medication for Opioid Use Disorder (Other)
Full MISSION
CTI + DRT + PS + MOUD
干预措施: MISSION Peer Support (Behavioral)
Full MISSION
CTI + DRT + PS + MOUD
干预措施: MISSION Dual Recovery Therapy (Behavioral)
CTI & DRT
CTI + DRT + MOUD
干预措施: Medication for Opioid Use Disorder (Other)
CTI & DRT
CTI + DRT + MOUD
干预措施: MISSION Critical Time Intervention (Behavioral)
CTI & DRT
CTI + DRT + MOUD
干预措施: MISSION Dual Recovery Therapy (Behavioral)
CTI & PS
CTI + PS + MOUD
干预措施: Medication for Opioid Use Disorder (Other)
CTI & PS
CTI + PS + MOUD
干预措施: MISSION Critical Time Intervention (Behavioral)
CTI & PS
CTI + PS + MOUD
干预措施: MISSION Peer Support (Behavioral)
结局指标
主要结局
Engagement in treatment
时间窗: 6 months
Measured by total days in treatment
Engagement in medication for opioid use disorder (MOUD)
时间窗: 6 months
Measured by percentage of days receiving MOUD
Engagement in outreach and linkage sessions
时间窗: 6 months
Measured by total number of outreach and linkage sessions
Self-report opioid use and other substance use
时间窗: 12 months
Measured by self-report days of use
Opioid use and other substance use (drug screen)
时间窗: 6 months
Measured by positive drug screens
Mental health functioning
时间窗: 12 months
Measured by self-report mental health symptoms on BASIS-24
PTSD symptoms
时间窗: 12 months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental health impairment
时间窗: 12 months
Measured by self-report on WHODAS 2.0
Psychiatric severity
时间窗: Baseline
Measured by Structured Clinical Interview for DSM-5 (SCID-RV)
Health functioning
时间窗: 12 months
Measured by the WHOQOL-BREF
Motivation for treatment
时间窗: 12 months
Measured by SOCRATES
Suicide Severity
时间窗: 12 months
Measured by C-SSRS
Therapeutic alliance
时间窗: 12 months
Measured by Working Alliance Inventory
Recovery Capital
时间窗: 12 months
Measured by Assessment of Recovery Capital
Chronic pain
时间窗: 12 months
Measured by Chronic Pain assessment
Medication Adherence
时间窗: 6 months
Measured by Medication Adherence Rating Scale
次要结局
- Mortality(6 months)
- Quality Adjusted Life Years (QALYs): health(12 months)
- Quality Adjusted Life Years (QALYs): quality of life(12 months)
研究者
David Smelson
Professor
University of Massachusetts, Worcester