Active — Not RecruitingNot Applicable

Supporting Treatment Access and Recovery Through Linkage and Support

United States208 participantsStarted 2023-05-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-report opioid use and other substance use

Timeframe: Baseline

Self-report opioid use and other substance use

Timeframe: 3-months

Self-report opioid use and other substance use

Timeframe: 6-months

Self-report opioid use and other substance use

Timeframe: 9-months

Mental Health Functioning

Timeframe: Baseline

Mental Health Functioning

Timeframe: 3-months

Mental Health Functioning

Timeframe: 6-months

Mental Health Functioning

Timeframe: 9-months

Trial details

NCT IDNCT05713695

SponsorUniversity of Massachusetts, Worcester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Mental Health Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Self-report opioid use and other substance use

Timeframe: Baseline

Self-report opioid use and other substance use

Timeframe: 3-months

Self-report opioid use and other substance use

Timeframe: 6-months

Self-report opioid use and other substance use

Timeframe: 9-months

Mental Health Functioning

Timeframe: Baseline

Mental Health Functioning

Timeframe: 3-months

Mental Health Functioning

Timeframe: 6-months

Mental Health Functioning

Timeframe: 9-months