Improving Social Connectedness Through Digital Health to Enhance Recovery from OUD Among the Justice Involved Population (STAR)

Lifespan

Status: Enrolling

Conditions: Opioid Use Disorder; Loneliness

Treatments: Behavioral: Marigold Mobile Peer Support Intervention; Behavioral: Resources

Study type: Interventional

Funder types: Other

Identifiers

NCT06896656

1R34DA058299 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

People with a history of Opioid Use Disorder and criminal justice involvement are more likely to experience loneliness following release from jail/prison leading to negative outcomes such as treatment dropout and increased substance use. Providing peer recovery support, particularly through a highly accessible, digital health platform, is a potential way to decrease loneliness in this population. The current study seeks to test whether a mobile peer recovery support app, delivered to individuals with a recent history of taking medication for opioid use disorder while in jail/prison, will improve outcomes for this vulnerable population.

Full description

Individuals with criminal justice involvement experience elevated rates of Opioid Use Disorder (OUD) and are at significantly higher risk of death from opioid overdose in the first year following release from jail/prison. Medications for OUD (MOUD) are an evidence-based approach to treating OUD and offer extensive benefits including lowering rates of mortality, illicit opioid use, HIV transmission, violent crime, and arrest. While many correctional settings have started to implement MOUD, there are significant challenges to continuing medication/treatment while transitioning back to the community. Intersectional stigma related to addiction and history of incarceration is associated with greater difficulties with reintegration, increased isolation, and heightened feelings of loneliness. Lack of social connectedness further serves as a risk factor for decreased retention in treatment, discontinuation of MOUD, and a return to substance use. Peer support is a key component of many evidence-based OUD recovery programs. When used in conjunction with MOUD, it has the potential to improve perceived social support, self-efficacy, and treatment engagement. However, access to live peer support has been challenged by COVID restrictions, highlighting a critical need for digital health platforms to deliver peer support. The Marigold Mobile Peer Support ("MPS") App is a dedicated, secure, mobile application that employs structured, live peer moderation to guide text-based conversations with groups of participants and behind-the-scenes natural language processing (NLP) to automatically identify "red flag" content within peer chats. While initial work demonstrates the utility of deploying the MPS App in outpatient treatment settings for OUD, it has yet to be tested in correctional settings or among justice-involved populations. The goal of the proposed application is to advance evidence-based and scalable treatments for OUD, by decreasing loneliness and enhancing perceived social support via novel application of an established mobile app among individuals with a history of engaging in MOUD while in jail/prison. The study will be accomplished through two primary aims: (1) develop an implementation manual to guide delivery of the MPS App for those with a recent (past year) history of engaging in MOUD while in jail/prison by conducting in-depth interviews with prospective app users and other key stakeholders; and (2) conduct a randomized controlled trial to assess feasibility, acceptability, and preliminary efficacy of the MPS App relative to enhanced treatment-as-usual among individuals with a recent (past year) history of engaging in MOUD while in jail/prison. Findings from this study will be used to develop a R01 application to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation study.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18+ years of age
• history of being prescribed medication for opioid use disorder (MOUD) while in jail or prison
• most recently released from prison with the past two years
• self-reported recovery for an Opioid Use Disorder (OUD)
• able to understand and speak English and to provide written and verbal consent
• anticipated discharge from jail/prison within 3 months if currently incarcerated

Exclusion criteria

• N/A

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

MPS App

Experimental group

Description:

This is the experimental arm. Participants assigned to this arm will receive access to the Marigold Health App (MPS) intervention. N = 60 participants will be assigned to this arm.

Treatment:

Behavioral: Marigold Mobile Peer Support Intervention

Enhanced Treatment as Usual

Active Comparator group

Description:

This is the active comparator arm. Participants assigned to this arm will receive enhanced treatment as usual. N = 30 participants will be assigned to this arm.

Treatment:

Behavioral: Resources