An interventional study of Full MISSION and Linkage Only Delivered by a Peer Specialist in Mental Health Disorders and Substance Use Disorders, sponsored by University of Massachusetts, Worcester. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 208 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Full MISSION
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.
Behavioral: Linkage Only Delivered by a Peer Specialist
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 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.
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time frame: Baseline
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time frame: 3-months
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time frame: 6-months
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Time frame: 9-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time frame: Baseline
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time frame: 3-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time frame: 6-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Time frame: 9-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time frame: Baseline
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time frame: 3-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time frame: 6-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Time frame: 9-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time frame: Baseline
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time frame: 3-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time frame: 6-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Time frame: 9-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time frame: Screening
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time frame: Baseline
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time frame: 3-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time frame: 6-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Time frame: 9-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time frame: Baseline
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time frame: 3-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time frame: 6-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time frame: 9-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Time frame: Baseline
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Time frame: 3-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Time frame: 6-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Time frame: 9-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Time frame: Baseline
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Time frame: 3-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Time frame: 6-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Time frame: 9-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Time frame: Baseline
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Time frame: 3-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Time frame: 6-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Time frame: 9-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time frame: Baseline
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time frame: 3-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time frame: 6-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Time frame: 9-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Time frame: Baseline
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Time frame: 3-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Time frame: 6-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Time frame: 9-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Time frame: Baseline
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Time frame: 3-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Time frame: 6-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Time frame: 9-months
Baseline Demographics
Self-reported using the Addiction Severity Index (ASI)
Time frame: Baseline
Suicide Severity
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Screening
Community Health & Social Needs
Self-report using the Accountable Health Communities \& Health-Related Social Needs
Time frame: Baseline
Fidelity to Intervention
Measured via clinical staff submitting weekly treatment fidelity logs
Time frame: Weekly
Acceptability & Appropriateness
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
Time frame: 6-months
Feasibility of Intervention
Using the Feasibility of Intervention Measure (FIM)
Time frame: 6-months
Satisfaction with Care
Self-report using the Treatment Satisfaction Questionnaire
Time frame: 6-months
Plan to share: Yes — Consistent with Health and Human Services/Center for Disease Control and Prevention (CDC) policy, research resources and data will be made readily available for research purposes to qualified individuals within the scientific community after publication of any scholarly work. Scholarly publications will also be immediately available to the public on PubMed Central. Additionally, raw and analyzed de-identified data used in publications will be responsibly shared through submissions to a CDC-approved data repository. Other methods for data sharing will be via presentations at professional conferences and, as findings permit, disclosure of summary data to professionals and the general public. To the extent feasible and appropriate, we will share pre-publication findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings. We expect to further disseminate the study via gray literature and the project website.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: De-identified data will be shared with qualified and approved researchers via an appropriate data repository. Research data will be destroyed 6 years after the end of the Fiscal Year in which the study is completed. The master list of identifiers will be destroyed at the 6-year mark or when all statistical analyses have been completed and scientific papers have been published, whichever comes first.
Access criteria: We will share findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings.
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Dec 2026, 43 months after the start.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 43 months is above that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Sep 2026 → Dec 2026 and completion Sep 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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