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

Not Applicable

Recruiting

• Conditions: Loneliness; Opioid Use Disorder

• Registration Number: NCT06896656
• Lead Sponsor: Rhode Island Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study Start: 2025-03-17
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-01-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social Support	Baseline, 1, 3, and 6 months.	Perceived social support will be assessed with the Multidimensional Scale of Perceived Social Support (MSPSS). This assessment is psychometrically sound, with adequate reliability and validity, and measures perceived social support from family, friends, and significant others among adults. Scores are averaged and range from 1 to 7, with 1 signifying the lowest level of social support and 7 signifying the highest.
Loneliness	Baseline, 1, 3, and 6 months.	Loneliness will be assessed with the 20-item UCLA Loneliness scale. Scores range from 20 to 80, where higher scores indicate greater loneliness.

Secondary Outcome Measures

Name	Time	Method
Substance Use	Baseline, 1, 3, and 6 months.	Self-reported substance use will be assessed with the Timeline Follow-Back interview and biochemically confirmed with Urine Drug Screens. Substance use will be operationalized as the percentage of days positive for drug use (separate by drug class) in between assessments.
Engagement in Medications for Opioid Use Disorder (MOUD)	Baseline, 1, 3, and 6 months.	Self-reported engagement in MOUD will be assessed with a Timeline Follow-Back interview and biochemically confirmed with Urine Drug Screens. Engagement in MOUD will be operationalized as the percentage of days positive for MOUD administration in between assessments.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States