Supporting Treatment Access and Recovery Through Linkage and Support

NCT ID: NCT05713695

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2026-09-30

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.

Conditions

Mental Health Disorders; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full MISSION

Participants assigned to this condition will receive full MISSION services. MISSION services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION Treatment Manual and Consumer Workbooks. MISSION teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study.

Group Type: EXPERIMENTAL

Full MISSION

Intervention Type: BEHAVIORAL

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: 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.

Linkage Only Delivered by a Peer Specialist

Our Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION materials or offer Peer led groups.

Group Type: ACTIVE_COMPARATOR

Linkage Only Delivered by a Peer Specialist

Intervention Type: BEHAVIORAL

Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.

Interventions

Full MISSION

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: 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.

Intervention Type: BEHAVIORAL

Linkage Only Delivered by a Peer Specialist

Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Massachusetts, Lowell

OTHER

Sponsor Role: collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

David Smelson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Smelson, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Smelson, PsyD

Role: CONTACT

David.Smelson@umassmed.edu

508-713-5420

Paige Shaffer, MPH

Role: CONTACT

Paige.Shaffer@umassmed.edu

978-609-2312

Facility Contacts

David Smelson, Psy.D.

Role: primary

david.smelson@umassmed.edu

Michael Andre, MPH

Role: backup

michael.andre@umassmed.edu

Other Identifiers

STUDY00000749

Identifier Type: -

Identifier Source: org_study_id