Mental Health DisordersSTAR-LSNCT05713695
Supporting Treatment Access and Recovery Through Linkage and Support
A study testing Full MISSION and Linkage Only Delivered by a Peer Specialist in people with Mental Health Disorders and Substance Use Disorders, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Disorders, Substance Use Disorders
- What is being tested?
- Full MISSION and Linkage Only Delivered by a Peer Specialist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services
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.
Read the 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
- Being tested
- Full MISSION, Linkage Only Delivered by a Peer Specialist
- 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
- Medical subject headings
- Substance-Related Disorders, Opiate Overdose, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full MISSIONBehavioural
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 SpecialistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Full MISSION | Experimental | 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. Receives: Behavioral: Full MISSION |
| Linkage Only Delivered by a Peer Specialist | Active comparator | 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. Receives: Behavioral: Linkage Only Delivered by a Peer Specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Measured: Baseline
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Measured: 3-months
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Measured: 6-months
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Measured: 9-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Measured: Baseline
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Measured: 3-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Measured: 6-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Measured: 9-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: Baseline
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 3-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 6-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 9-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Measured: Baseline
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Measured: 3-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Measured: 6-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Measured: 9-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Measured: Screening
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Measured: Baseline
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Measured: 3-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Measured: 6-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Measured: 9-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Measured: Baseline
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Measured: 3-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Measured: 6-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Measured: 9-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Measured: Baseline
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Measured: 3-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Measured: 6-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Measured: 9-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Measured: Baseline
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Measured: 3-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Measured: 6-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Measured: 9-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Measured: Baseline
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Measured: 3-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Measured: 6-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Measured: 9-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Measured: Baseline
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Measured: 3-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Measured: 6-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Measured: 9-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Measured: Baseline
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Measured: 3-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Measured: 6-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Measured: 9-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Measured: Baseline
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Measured: 3-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Measured: 6-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Measured: 9-months
Baseline Demographics
Self-reported using the Addiction Severity Index (ASI)
Measured: Baseline
Suicide Severity
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Screening
Community Health & Social Needs
Self-report using the Accountable Health Communities \& Health-Related Social Needs
Measured: Baseline
Fidelity to Intervention
Measured via clinical staff submitting weekly treatment fidelity logs
Measured: Weekly
Acceptability & Appropriateness
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
Measured: 6-months
Feasibility of Intervention
Using the Feasibility of Intervention Measure (FIM)
Measured: 6-months
Satisfaction with Care
Self-report using the Treatment Satisfaction Questionnaire
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start24 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisordersStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Massachusetts, Lowell, University of Massachusetts, Amherst
- Responsible party
- Principal investigator, David Smelson, University of Massachusetts, Worcester
- Investigators
- David Smelson, PsyD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713695
- Sponsor's protocol ID
- STUDY00000749
- Acronym
- STAR-LS
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services
- ClinicalTrials.gov ID
- NCT05713695
- Acronym / sponsor ID
- STAR-LS / STUDY00000749
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Massachusetts, Lowell, University of Massachusetts, Amherst
- Study start
- 24 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Full MISSION | Experimental | Behavioral: Full MISSIONParticipants 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. |
| Linkage Only Delivered by a Peer Specialist | Active comparator | Behavioral: Linkage Only Delivered by a Peer SpecialistOur 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full MISSIONMISSION 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. | Behavioural | Full MISSION |
| Linkage Only Delivered by a Peer SpecialistLinkage 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. | Behavioural | Linkage Only Delivered by a Peer Specialist |
Primary outcome
Self-report opioid use and other substance use
Time frame: Baseline
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Self-report opioid use and other substance use
Time frame: 3-months
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Self-report opioid use and other substance use
Time frame: 6-months
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Self-report opioid use and other substance use
Time frame: 9-months
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Mental Health Functioning
Time frame: Baseline
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental Health Functioning
Time frame: 3-months
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental Health Functioning
Time frame: 6-months
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental Health Functioning
Time frame: 9-months
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
PTSD Symptoms
Time frame: Baseline
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD Symptoms
Time frame: 3-months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD Symptoms
Time frame: 6-months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD Symptoms
Time frame: 9-months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental Health Impairment
Time frame: Baseline
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental Health Impairment
Time frame: 3-months
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental Health Impairment
Time frame: 6-months
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental Health Impairment
Time frame: 9-months
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Psychiatric Severity
Time frame: Screening
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Time frame: Baseline
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Time frame: 3-months
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Time frame: 6-months
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Psychiatric Severity
Time frame: 9-months
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Health functioning
Time frame: Baseline
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Time frame: 3-months
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Time frame: 6-months
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Time frame: 9-months
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Therapeutic Alliance Client
Time frame: Baseline
Measured by Working Alliance Inventory-C
Therapeutic Alliance Client
Time frame: 3-months
Measured by Working Alliance Inventory-C
Therapeutic Alliance Client
Time frame: 6-months
Measured by Working Alliance Inventory-C
Therapeutic Alliance Client
Time frame: 9-months
Measured by Working Alliance Inventory-C
Therapeutic Alliance Therapist
Time frame: Baseline
Measured by Working Alliance Inventory-T
Therapeutic Alliance Therapist
Time frame: 3-months
Measured by Working Alliance Inventory-T
Therapeutic Alliance Therapist
Time frame: 6-months
Measured by Working Alliance Inventory-T
Therapeutic Alliance Therapist
Time frame: 9-months
Measured by Working Alliance Inventory-T
Recovery Capital
Time frame: Baseline
Measured by Assessment of Recovery Capital (ARC)
Recovery Capital
Time frame: 3-months
Measured by Assessment of Recovery Capital (ARC)
Recovery Capital
Time frame: 6-months
Measured by Assessment of Recovery Capital (ARC)
Recovery Capital
Time frame: 9-months
Measured by Assessment of Recovery Capital (ARC)
Alcohol or other drug 12-Step Participation
Time frame: Baseline
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Alcohol or other drug 12-Step Participation
Time frame: 3-months
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Alcohol or other drug 12-Step Participation
Time frame: 6-months
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Alcohol or other drug 12-Step Participation
Time frame: 9-months
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Overdose Risk
Time frame: Baseline
Self-report using the Overdose Risk Questionnaire (OdRi)
Overdose Risk
Time frame: 3-months
Self-report using the Overdose Risk Questionnaire (OdRi)
Overdose Risk
Time frame: 6-months
Self-report using the Overdose Risk Questionnaire (OdRi)
Overdose Risk
Time frame: 9-months
Self-report using the Overdose Risk Questionnaire (OdRi)
Number of Outreach and Linkage Sessions
Time frame: Baseline
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Number of Outreach and Linkage Sessions
Time frame: 3-months
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Number of Outreach and Linkage Sessions
Time frame: 6-months
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Number of Outreach and Linkage Sessions
Time frame: 9-months
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Baseline Demographics
Time frame: Baseline
Self-reported using the Addiction Severity Index (ASI)
Suicide Severity
Time frame: Screening
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Community Health & Social Needs
Time frame: Baseline
Self-report using the Accountable Health Communities \& Health-Related Social Needs
Fidelity to Intervention
Time frame: Weekly
Measured via clinical staff submitting weekly treatment fidelity logs
Acceptability & Appropriateness
Time frame: 6-months
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
Feasibility of Intervention
Time frame: 6-months
Using the Feasibility of Intervention Measure (FIM)
Satisfaction with Care
Time frame: 6-months
Self-report using the Treatment Satisfaction Questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Smelson, PsyD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full MISSION and Linkage Only Delivered by a Peer Specialist in people with Mental Health Disorders and Substance Use Disorders, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report opioid use and other substance use (time frame: Baseline). The study lists 56 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.