Team Approach vs Peer Support for Dual Diagnosis

(STAR-LS Trial)

Overseen By Paige Shaffer, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Severe alcohol use, High dose benzodiazepines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 6 months

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two support methods for individuals with both substance use and mental health issues. One group receives Full MISSION, which involves a comprehensive team approach with mental health and substance use treatment. The other group receives assistance from a Peer Specialist who connects them to community services. The researchers aim to determine which method better improves treatment engagement and overall health outcomes. Individuals with both substance use and mental health disorders, who are part of the Worcester Hub and have not participated in similar treatment for at least three months, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in mental health and substance use support.

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.

What prior data suggests that these interventions are safe for individuals with co-occurring disorders?

Research has shown that the MISSION model is a proven program designed to assist individuals with both mental health and substance use issues. It integrates treatments for these conditions with support services. Studies have found that combining different types of support can be highly effective for individuals facing both challenges. The program has been implemented in various settings, including for veterans, and emphasizes helping individuals achieve independence and sobriety.

Regarding safety, strong scientific support exists for using combined mental health and case management services. This approach is generally well-received and has been safely applied to diverse groups. No specific reports of negative effects related to the MISSION model appear in the sources provided, suggesting the program is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing Full MISSION services and Linkage Only support because it explores innovative ways to treat dual diagnosis, which involves both mental health and substance use disorders. Unlike standard treatments that might tackle each condition separately, the Full MISSION approach integrates mental health and substance use treatment over six months. This includes structured sessions with both a case manager and a peer support specialist, using a comprehensive treatment manual and workbooks. On the other hand, the Linkage Only approach focuses on connecting participants with community services through a peer specialist, emphasizing informal support without integrated treatment. This trial could uncover more effective strategies for providing holistic and accessible care for those with dual diagnoses.

What evidence suggests that this trial's treatments could be effective for co-occurring substance use and mental health disorders?

Research has shown that the MISSION program, available to participants in this trial, effectively addresses mental health and substance use issues. Past studies found that individuals who participated in MISSION engaged more in treatment and experienced improved mental health. These benefits appeared in settings like veteran services, where similar needs exist. The program provides comprehensive support through therapy, peer assistance, and connections to community resources, which are believed to enhance independence and sobriety. In contrast, the peer support component of the program, another treatment option in this trial, offers basic assistance without therapy, making it less comprehensive than the full MISSION model. This suggests that while peer support is beneficial, the full MISSION approach may lead to greater improvements. ^{1 3 6 7 8}

Who Is on the Research Team?

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?

Group I: Full MISSION Experimental Treatment 1 Intervention

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.

Group II: Linkage Only Delivered by a Peer Specialist Active Control 1 Intervention

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.

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

Approved in United States as MISSION Program for:

• Co-occurring substance use and mental health disorders

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot study involving 80 adults with recent non-fatal opioid overdoses, trained peer interventionists successfully delivered a Peer Recovery Support Services (PRSS) intervention, achieving a treatment enrollment success rate between 16% and 60%.

The interventionists reported no negative effects from their role, indicating that peer-led interventions can be implemented safely and effectively with limited training, although further research is needed to understand the factors influencing their varying success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Kropp, F., Wilder, C., Theobald, J., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Peer providers play varying roles within integrated behavioral health teams, with some being highly central to the network while others are more peripheral, indicating differences in their influence and integration.

The positioning of peer providers within these teams seems to be linked to their mental health status, suggesting that tailored support is necessary to enhance their effectiveness in integrated care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where do Peer Providers Fit into Newly Integrated Mental Health and Primary Care Teams? A Mixed Method Study. Siantz, E., Rice, E., Henwood, B., et al.[2019]

In a study involving 292 participants from 31 psychiatric outreach teams, the presence of peer specialists (PS) was associated with a significantly lower risk of hospitalization, with a hazard ratio of 0.53, indicating a protective effect against hospital admissions.

While the presence of PS improved hospitalization rates, there were no significant differences in social functioning or problem behaviors between clients cared for by teams with or without PS after 6 months, suggesting that while PS may help reduce hospitalizations, their impact on overall social functioning needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kido, Y., Kawakami, N., Kayama, M.[2019]

In a study of 137 adults with co-occurring psychosis and substance use disorders, adding peer recovery supports to standard care improved engagement in treatment and reduced alcohol use over time.

At three months, skills training alone helped reduce symptoms and alcohol use, while peer support enhanced social connections and outpatient service use; by nine months, it further decreased symptoms and inpatient readmissions, highlighting the long-term benefits of peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing outcomes for persons with co-occurring disorders through skills training and peer recovery support. O'Connell, MJ., Flanagan, EH., Delphin-Rittmon, ME., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Individuals with disabilities may have higher rates of opioid and substance use disorders, highlighting the need for tailored treatment approaches, such as peer support.

Key themes for effective peer support include ensuring accessibility, matching peers appropriately, and focusing on recruitment and training, which are crucial for meeting the unique needs of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support at the Intersection of Disability and Opioid (Mis)Use: Key Stakeholders Provide Essential Considerations. Nicholson, J., Valentine, A., Ledingham, E., et al.[2022]

The PEER program effectively identified clients with substance use disorders who had high needs for social support and were at risk of recidivism, demonstrating its potential to address complex health and social issues among this population.

Despite challenges in client contact and funding stability, the program's sustainability was rated as stable, suggesting that with adjustments to service delivery and risk stratification, it could be further optimized for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where It Really Counts: Feasibility and Potential of the Peer Engaged Empowered Recovery Program for Substance-Dependent Jail Inmates. Parekh, T., Cuellar, AE., Farina-Morse, M., et al.[2022]

Incorporating peers with lived experiences into nonpeer-led drug use service settings can enhance client outcomes and promote personal and professional growth for the peers themselves, benefiting organizations and society as a whole.

However, peers face challenges such as emotional triggers and boundary issues, highlighting the need for organizations to adapt their missions and cultures to support the unique contributions and values of peer workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of peer work in drug use service settings: A systematic review of qualitative evidence. Chen, Y., Yuan, Y., Reed, BG.[2023]

In a study of 785 patients with substance use disorders, peer support specialists (PSSs) were effective in linking patients to treatment, but there were significant racial disparities, with White patients being more likely to enroll in treatment compared to Black patients.

Specifically, White patients had a 61% higher likelihood of being successfully linked to care after emergency department visits, highlighting the need for further research to address these disparities and improve access to treatment for all racial groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial disparities in linkage to care among patients with substance use disorders. Webb, CP., Huecker, M., Shreffler, J., et al.[2022]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/79/NCT02942979/Prot_SAP_000.pdf

Maintaining Independence and Sobriety through Systems ... The MISSION-Vet team delivers the following five treatment components: critical time intervention (CTI), dual recovery therapy (DRT), peer ...

2. missionmodel.org missionmodel.org/mission-model

About Mission Model MISSION is an evidence-based intervention developed in 2001 to specifically meet mental health, substance misuse and other psychosocial needs of individuals.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5935954/

An evidence-based co-occurring disorder intervention in VA ... This paper reports Veteran level outcome data on treatment engagement and select behavioral health outcomes for Veterans exposed to the MISSION- ...

4. va.gov va.gov/homeless/docs/center/mission_veteran_treatment_manual.pdf

Mission-Vet this Maintaining independence and sobriety through systems integration, Outreach and networking. (MissiOn) treatment Manual: veteran's ...

5. psychiatryonline.org psychiatryonline.org/ps/doi/10.1176/appi.ps.201800570

Implementation of MISSION–Criminal Justice in a ... This pilot study examined the preliminary effectiveness of Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking–Criminal ...

6. naco.org naco.org/resource/co-occurring

Comprehensive Services for People With Co-Occurring ... Strong scientific evidence supports the integration of multiple behavioral health and case management services for people with co-occurring disorders.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317293/

Intervention for Justice-Involved Homeless Veterans With Co ... MISSION-CJ: Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking Criminal Justice version. bCOD: co-occurring disorder.

8. missionmodel.org missionmodel.org/

The MISSION Model The MISSION model is a flexible, evidence-based outpatient treatment approach focused on improving client outcomes and social determinants of health needs.