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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
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.
University of Massachusetts Medical School
Worcester, Massachusetts, United States
RECRUITINGSelf-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
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