208 Participants Needed

Team Approach vs Peer Support for Dual Diagnosis

(STAR-LS Trial)

DS
PS
Overseen ByPaige Shaffer, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

Is the Team Approach vs Peer Support for Dual Diagnosis generally safe for humans?

Research on peer support interventions, including those for substance use disorders, suggests they are generally safe. Studies have shown that peer interventionists can deliver support without negative effects on themselves or participants, indicating a good safety profile.12345

How is the Full MISSION treatment different from other treatments for dual diagnosis?

The Full MISSION treatment is unique because it combines a team approach with peer support, where individuals with lived experience (peer specialists) are involved in the care process, potentially reducing hospitalizations and improving social functioning for those with dual diagnosis (mental illness and substance use disorder).16789

What data supports the effectiveness of this treatment?

Research shows that adding peer-led support to treatment can help reduce substance use and improve engagement in care for people with both mental health and substance use disorders. Peer recovery specialists have been effective in linking individuals to treatment and supporting recovery, especially in underserved communities.1281011

Who Is on the Research Team?

DS

David Smelson, PsyD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with co-occurring substance use and mental health disorders, not currently engaged in similar treatments or haven't seen their provider in 3 months. It's not for those who are acutely psychotic or suicidal with a plan, homicidal, have severe alcohol use disorder, or need high dose benzodiazepine detoxification.

Inclusion Criteria

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
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

Individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal
Individuals with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either MISSION services or linkage care from a Peer Specialist for 6 months

6 months
13 sessions (MISSION) or 11 sessions (Peer Specialist)

Follow-up

Participants are monitored for mental health functioning, substance use, and other outcomes

3 months
Regular assessments

Process Evaluation

Conduct a sequential mixed methods process evaluation to inform sustainability and future implementation

Concurrent with treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Full MISSION
  • Linkage Only Delivered by a Peer Specialist
Trial Overview The study compares MISSION (a comprehensive team-based approach) to just getting linked up by a Peer Specialist for people with substance and mental health issues. The goal is to see which method better improves treatment engagement and health outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Full MISSIONExperimental Treatment1 Intervention
Group II: Linkage Only Delivered by a Peer SpecialistActive Control1 Intervention

Full MISSION is already approved in United States for the following indications:

🇺🇸
Approved in United States as MISSION Program for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Centers for Disease Control and Prevention

Collaborator

Trials
902
Recruited
25,020,000+

University of Massachusetts, Lowell

Collaborator

Trials
21
Recruited
10,300+

University of Massachusetts, Amherst

Collaborator

Trials
83
Recruited
3,474,000+

Published Research Related to This Trial

An open-label trial with 8 participants showed that peer recovery specialists (PRSs) can effectively implement an adapted evidence-based intervention (EBI) to support recovery and reduce depression in underserved communities.
Participants who completed the intervention experienced significant decreases in substance use and depressive symptoms, indicating that PRSs can help improve access to treatment and support for individuals from low-income backgrounds.
Peer Activate: A Feasibility Trial of a Peer-Delivered Intervention to Decrease Disparities in Substance Use, Depression, and Linkage to Substance Use Treatment.Felton, JW., Kleinman, MB., Doran, K., et al.[2023]
The Peer Activate intervention, delivered by peer recovery specialists, showed high feasibility and acceptability, with 86.5% of participants initiating the program and 81.3% completing at least 75% of sessions, indicating strong engagement among low-income, minoritized populations.
Participants in the Peer Activate program had a significantly higher retention rate in methadone treatment (88.6%) compared to those receiving standard treatment, along with improved adherence to methadone and reduced substance use frequency, highlighting the potential effectiveness of this approach.
Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial.Magidson, JF., Kleinman, MB., Bradley, V., et al.[2023]
The peer-led self-help (PLSH) program at Bellevue Hospital significantly improved aftercare referral acceptance (93% vs. 74%) and attendance (52% vs. 30%) among patients with no prior psychiatric hospitalizations, indicating its effectiveness in supporting recovery.
Chronically impaired patients with a history of psychiatric hospitalizations also benefited from the PLSH approach, with a higher referral acceptance rate (96% vs. 81%) compared to those in standard psychiatric units, suggesting that this model could reduce recidivism and lower overall healthcare costs.
Evaluation of a model for the treatment of combined mental illness and substance abuse: the Bellevue model for peer-led treatment in systems change.Dermatis, H., Galanter, M., Trujillo, M., et al.[2019]

Citations

Peer Activate: A Feasibility Trial of a Peer-Delivered Intervention to Decrease Disparities in Substance Use, Depression, and Linkage to Substance Use Treatment. [2023]
Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. [2023]
Evaluation of a model for the treatment of combined mental illness and substance abuse: the Bellevue model for peer-led treatment in systems change. [2019]
Enhancing outcomes for persons with co-occurring disorders through skills training and peer recovery support. [2020]
Where It Really Counts: Feasibility and Potential of the Peer Engaged Empowered Recovery Program for Substance-Dependent Jail Inmates. [2022]
Experiences of peer work in drug use service settings: A systematic review of qualitative evidence. [2023]
The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. [2022]
Racial disparities in linkage to care among patients with substance use disorders. [2022]
Comparison of hospital admission rates for psychiatric patients cared for by multidisciplinary outreach teams with and without peer specialist: a retrospective cohort study of Japanese Outreach Model Project 2011-2014. [2019]
Peer Support at the Intersection of Disability and Opioid (Mis)Use: Key Stakeholders Provide Essential Considerations. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Where do Peer Providers Fit into Newly Integrated Mental Health and Primary Care Teams? A Mixed Method Study. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security