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OpenTrials
Active, Not Recruiting

NCT Number: NCT05713695

Supporting Treatment Access and Recovery Through Linkage and Support

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mental Health Disorders Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Drug Misuse Drug Overdose Impulsive Behavior Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Prescription Drug Misuse Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full MISSION

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

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Mental Health Functioning

    Time frame: Baseline

    Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

  6. Mental Health Functioning

    Time frame: 3-months

    Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

  7. Mental Health Functioning

    Time frame: 6-months

    Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

  8. Mental Health Functioning

    Time frame: 9-months

    Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

  9. PTSD Symptoms

    Time frame: Baseline

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  10. PTSD Symptoms

    Time frame: 3-months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  11. PTSD Symptoms

    Time frame: 6-months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  12. PTSD Symptoms

    Time frame: 9-months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  13. Mental Health Impairment

    Time frame: Baseline

    Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)

  14. Mental Health Impairment

    Time frame: 3-months

    Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)

  15. Mental Health Impairment

    Time frame: 6-months

    Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)

  16. Mental Health Impairment

    Time frame: 9-months

    Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)

  17. Psychiatric Severity

    Time frame: Screening

    Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)

  18. Psychiatric Severity

    Time frame: Baseline

    Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)

  19. Psychiatric Severity

    Time frame: 3-months

    Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)

  20. Psychiatric Severity

    Time frame: 6-months

    Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)

  21. Psychiatric Severity

    Time frame: 9-months

    Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)

  22. Health functioning

    Time frame: Baseline

    Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

  23. Health functioning

    Time frame: 3-months

    Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

  24. Health functioning

    Time frame: 6-months

    Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

  25. Health functioning

    Time frame: 9-months

    Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

  26. Therapeutic Alliance Client

    Time frame: Baseline

    Measured by Working Alliance Inventory-C

  27. Therapeutic Alliance Client

    Time frame: 3-months

    Measured by Working Alliance Inventory-C

  28. Therapeutic Alliance Client

    Time frame: 6-months

    Measured by Working Alliance Inventory-C

  29. Therapeutic Alliance Client

    Time frame: 9-months

    Measured by Working Alliance Inventory-C

  30. Therapeutic Alliance Therapist

    Time frame: Baseline

    Measured by Working Alliance Inventory-T

  31. Therapeutic Alliance Therapist

    Time frame: 3-months

    Measured by Working Alliance Inventory-T

  32. Therapeutic Alliance Therapist

    Time frame: 6-months

    Measured by Working Alliance Inventory-T

  33. Therapeutic Alliance Therapist

    Time frame: 9-months

    Measured by Working Alliance Inventory-T

  34. Recovery Capital

    Time frame: Baseline

    Measured by Assessment of Recovery Capital (ARC)

  35. Recovery Capital

    Time frame: 3-months

    Measured by Assessment of Recovery Capital (ARC)

  36. Recovery Capital

    Time frame: 6-months

    Measured by Assessment of Recovery Capital (ARC)

  37. Recovery Capital

    Time frame: 9-months

    Measured by Assessment of Recovery Capital (ARC)

  38. Alcohol or other drug 12-Step Participation

    Time frame: Baseline

    Measured by self-report using the Alcoholics Anonymous Inventory (AAI)

  39. Alcohol or other drug 12-Step Participation

    Time frame: 3-months

    Measured by self-report using the Alcoholics Anonymous Inventory (AAI)

  40. Alcohol or other drug 12-Step Participation

    Time frame: 6-months

    Measured by self-report using the Alcoholics Anonymous Inventory (AAI)

  41. Alcohol or other drug 12-Step Participation

    Time frame: 9-months

    Measured by self-report using the Alcoholics Anonymous Inventory (AAI)

  42. Overdose Risk

    Time frame: Baseline

    Self-report using the Overdose Risk Questionnaire (OdRi)

  43. Overdose Risk

    Time frame: 3-months

    Self-report using the Overdose Risk Questionnaire (OdRi)

  44. Overdose Risk

    Time frame: 6-months

    Self-report using the Overdose Risk Questionnaire (OdRi)

  45. Overdose Risk

    Time frame: 9-months

    Self-report using the Overdose Risk Questionnaire (OdRi)

  46. Number of Outreach and Linkage Sessions

    Time frame: Baseline

    Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet

  47. Number of Outreach and Linkage Sessions

    Time frame: 3-months

    Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet

  48. Number of Outreach and Linkage Sessions

    Time frame: 6-months

    Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet

  49. Number of Outreach and Linkage Sessions

    Time frame: 9-months

    Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet

  50. Baseline Demographics

    Time frame: Baseline

    Self-reported using the Addiction Severity Index (ASI)

  51. Suicide Severity

    Time frame: Screening

    Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)

  52. Community Health & Social Needs

    Time frame: Baseline

    Self-report using the Accountable Health Communities & Health-Related Social Needs

  53. Fidelity to Intervention

    Time frame: Weekly

    Measured via clinical staff submitting weekly treatment fidelity logs

  54. Acceptability & Appropriateness

    Time frame: 6-months

    Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)

  55. Feasibility of Intervention

    Time frame: 6-months

    Using the Feasibility of Intervention Measure (FIM)

  56. Satisfaction with Care

    Time frame: 6-months

    Self-report using the Treatment Satisfaction Questionnaire

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Centers for Disease Control and Prevention
  • University of Massachusetts, Amherst
  • University of Massachusetts, Lowell

Registry information

Official study title

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

Acronym: STAR-LS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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