Skip to content

Supporting Treatment Access and Recovery Through Linkage and Support

Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05713695
Acronym
STAR-LS
Enrollment
208
Registered
2023-02-06
Start date
2023-05-24
Completion date
2026-09-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALFull 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.

BEHAVIORALLinkage 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.

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
University of Massachusetts, Lowell
CollaboratorOTHER
University of Massachusetts, Amherst
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Self-report opioid use and other substance useBaselineMeasured by self-report days of use using the Time-line Follow Back (TLFB)
Mental Health FunctioningBaselineMeasured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
PTSD SymptomsBaselineMeasured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental Health ImpairmentBaselineMeasured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Psychiatric SeverityScreeningMeasured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Health functioningBaselineMeasured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Therapeutic Alliance ClientBaselineMeasured by Working Alliance Inventory-C
Therapeutic Alliance TherapistBaselineMeasured by Working Alliance Inventory-T
Recovery CapitalBaselineMeasured by Assessment of Recovery Capital (ARC)
Alcohol or other drug 12-Step ParticipationBaselineMeasured by self-report using the Alcoholics Anonymous Inventory (AAI)
Overdose RiskBaselineSelf-report using the Overdose Risk Questionnaire (OdRi)
Number of Outreach and Linkage SessionsBaselineSelf-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Baseline DemographicsBaselineSelf-reported using the Addiction Severity Index (ASI)
Suicide SeverityScreeningSelf-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Community Health & Social NeedsBaselineSelf-report using the Accountable Health Communities \& Health-Related Social Needs
Fidelity to InterventionWeeklyMeasured via clinical staff submitting weekly treatment fidelity logs
Acceptability & Appropriateness6-monthsUsing the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
Feasibility of Intervention6-monthsUsing the Feasibility of Intervention Measure (FIM)
Satisfaction with Care6-monthsSelf-report using the Treatment Satisfaction Questionnaire

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Smelson, PsyD

University of Massachusetts, Worcester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026