Clinical trial NCT05713695: Supporting Treatment Access and Recovery Through Linkage and Support
Official title: Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Disorders
Substance Use Disorders
Keywords: Co-Occurring Disorders
Opioid Overdose
Mental Health Disorders
Substance Use
Medication for Opioid Use Disorder (MOUD)
Peer Support
Medication Assisted Treatment (MAT)
Healthcare Access
Social Determinants of Health
Coordination of Care
Socioecological Model
Multi-component Interventions
Addiction
Equity
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: University of Massachusetts, Lowell
name: University of Massachusetts, Amherst
First posted: 2023-02-06
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.

Detailed description: Addiction is a growing public health problem in the United States (U.S.), with nearly 21 million Americans meeting criteria for substance use disorder (SUD), 1.6 million meeting criteria for opioid use disorder (OUD), and opioid-related overdoses have increased by 50% over the past 5 years. Among people with SUD, 49% have comorbid mental health disorders (COD). Individuals with COD are vulnerable to substance use relapses, mental illness exacerbations, overdoses, homelessness, and criminal justice involvement. However, despite the high rates of morbidity, mortality, and broad social determinant of health needs among people with COD, only 8% of individuals in the U.S. received treatment for both mental illness and SUD. Among those with a COD receiving treatment, 6-month engagement rates are as low as 16% for psychosocial treatments, and 90% of individuals leaving treatment will relapse within 12 weeks. Massachusetts is also hard hit, with a 16% higher SUD prevalence compared to the U.S., and Worcester, the second largest city in Massachusetts, is disproportionately affected by SUD, having one of the highest overdose rates in the state and is ranked 2nd on the Center for Disease Control and Prevention's social vulnerability index. These findings highlight the need to improve treatment access and engagement to support recovery in Worcester, Massachusetts. Both linkage and multicomponent wraparound models have gained popularity as a solution to increase treatment access and engagement. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent linkage and treatment approach, providing assertive outreach linkage support combined with psychosocial treatment, delivered by a cross disciplinary team. MISSION is aligned with the Social Ecological Model (SEM) to address multilevel client needs via 3 evidence-based practices. They include 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated group therapy for COD; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. In response to Funding Opportunity Announcement (RFA-CE-22-010), the proposed 3-year Hybrid Type I study, "Supporting Treatment Access and Recovery through Linkage and Support (STAR-LS)," will recruit and randomize 208 patients with COD in Worcester, MA in the Hub, a program run by the Worcester Health and Human Services to one of the following conditions: 1) MISSION; or 2) Peer Support (linkage only). There are three specific aims: Aim 1: To evaluate the effectiveness of MISSION or compared to Peer Support to improve engagement, substance use and mental health symptoms. Aim 2: To examine mechanisms of action of the interventions. Aim 3: To conduct a sequential mixed methods process evaluation to inform sustainability and future implementation. This proposal is aligned with CDC's Strategic Priority Areas and Health People 2030 Core Objectives as it intends to improve behavioral health outcomes strengthen and sustain the recovery ecosystem for people with COD.

Eligibility criteria: Inclusion Criteria:

* Are 18 or older;
* Have a COD (1 or more substance use disorders (e.g., alcohol and illicit substances), and a mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia);
* Are in the Hub; and
* Are not engaged in other ongoing multi-component treatment for COD with a behavioral health treatment provider or have not seen their provider for at least 3 months.

Exclusion Criteria:

* We will exclude individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal
* Or with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification.

Primary outcomes:
measure: Self-report opioid use and other substance use
timeFrame: Baseline
measure: Self-report opioid use and other substance use
timeFrame: 3-months
measure: Self-report opioid use and other substance use
timeFrame: 6-months
measure: Self-report opioid use and other substance use
timeFrame: 9-months
measure: Mental Health Functioning
timeFrame: Baseline
measure: Mental Health Functioning
timeFrame: 3-months
measure: Mental Health Functioning
timeFrame: 6-months
measure: Mental Health Functioning
timeFrame: 9-months
measure: PTSD Symptoms
timeFrame: Baseline
measure: PTSD Symptoms
timeFrame: 3-months
measure: PTSD Symptoms
timeFrame: 6-months
measure: PTSD Symptoms
timeFrame: 9-months
measure: Mental Health Impairment
timeFrame: Baseline
measure: Mental Health Impairment
timeFrame: 3-months
measure: Mental Health Impairment
timeFrame: 6-months
measure: Mental Health Impairment
timeFrame: 9-months
measure: Psychiatric Severity
timeFrame: Screening
measure: Psychiatric Severity
timeFrame: Baseline
measure: Psychiatric Severity
timeFrame: 3-months
measure: Psychiatric Severity
timeFrame: 6-months
measure: Psychiatric Severity
timeFrame: 9-months
measure: Health functioning
timeFrame: Baseline
measure: Health functioning
timeFrame: 3-months
measure: Health functioning
timeFrame: 6-months
measure: Health functioning
timeFrame: 9-months
measure: Therapeutic Alliance Client
timeFrame: Baseline
measure: Therapeutic Alliance Client
timeFrame: 3-months
measure: Therapeutic Alliance Client
timeFrame: 6-months
measure: Therapeutic Alliance Client
timeFrame: 9-months
measure: Therapeutic Alliance Therapist
timeFrame: Baseline
measure: Therapeutic Alliance Therapist
timeFrame: 3-months
measure: Therapeutic Alliance Therapist
timeFrame: 6-months
measure: Therapeutic Alliance Therapist
timeFrame: 9-months
measure: Recovery Capital
timeFrame: Baseline
measure: Recovery Capital
timeFrame: 3-months
measure: Recovery Capital
timeFrame: 6-months
measure: Recovery Capital
timeFrame: 9-months
measure: Alcohol or other drug 12-Step Participation
timeFrame: Baseline
measure: Alcohol or other drug 12-Step Participation
timeFrame: 3-months
measure: Alcohol or other drug 12-Step Participation
timeFrame: 6-months
measure: Alcohol or other drug 12-Step Participation
timeFrame: 9-months
measure: Overdose Risk
timeFrame: Baseline
measure: Overdose Risk
timeFrame: 3-months
measure: Overdose Risk
timeFrame: 6-months
measure: Overdose Risk
timeFrame: 9-months
measure: Number of Outreach and Linkage Sessions
timeFrame: Baseline
measure: Number of Outreach and Linkage Sessions
timeFrame: 3-months
measure: Number of Outreach and Linkage Sessions
timeFrame: 6-months
measure: Number of Outreach and Linkage Sessions
timeFrame: 9-months
measure: Baseline Demographics
timeFrame: Baseline
measure: Suicide Severity
timeFrame: Screening
measure: Community Health & Social Needs
timeFrame: Baseline
measure: Fidelity to Intervention
timeFrame: Weekly
measure: Acceptability & Appropriateness
timeFrame: 6-months
measure: Feasibility of Intervention
timeFrame: 6-months
measure: Satisfaction with Care
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: David Smelson, PsyD
role: PRINCIPAL_INVESTIGATOR
References: