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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Loneliness Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MPS App

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.

Group Type EXPERIMENTAL

Marigold Mobile Peer Support Intervention

Intervention Type BEHAVIORAL

The MPS App is a secure platform that allows text-based peer support for individuals in recovery from OUD. Participants assigned to this condition will be enrolled on a rolling basis into a peer support group on the app. All participants will receive onboarding assistance and will have access to the app for 6 months.

The app will include live moderation from a certified Peer Recovery Support Specialist and trained research assistants. Moderators will begin discussions with prompts and regulate the flow of conversation with standardized text language. Moderators will be able to respond in real-time to malicious messages or other "flags" that could impact participant safety. Built in natural language processing algorithms will also detect language requiring intervention and automatically alter the moderators and on-call clinicians.

Enhanced Treatment as Usual

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.

Group Type ACTIVE_COMPARATOR

Resources

Intervention Type BEHAVIORAL

A list of online peer support and mental health resources, drawn from SAMSHA and equivalent websites, will be provided to all participants, as an enhanced adjunct to their standard recovery plans.

Interventions

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Marigold Mobile Peer Support Intervention

The MPS App is a secure platform that allows text-based peer support for individuals in recovery from OUD. Participants assigned to this condition will be enrolled on a rolling basis into a peer support group on the app. All participants will receive onboarding assistance and will have access to the app for 6 months.

The app will include live moderation from a certified Peer Recovery Support Specialist and trained research assistants. Moderators will begin discussions with prompts and regulate the flow of conversation with standardized text language. Moderators will be able to respond in real-time to malicious messages or other "flags" that could impact participant safety. Built in natural language processing algorithms will also detect language requiring intervention and automatically alter the moderators and on-call clinicians.

Intervention Type BEHAVIORAL

Resources

A list of online peer support and mental health resources, drawn from SAMSHA and equivalent websites, will be provided to all participants, as an enhanced adjunct to their standard recovery plans.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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