Clinical trial NCT06896656: Improving Social Connectedness Through Digital Health to Enhance Recovery from OUD Among the Justice Involved Population
Official title: Improving Social Connectedness Through Digital Health to Enhance Recovery from OUD Among the Justice Involved Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Opioid Use Disorder
Keywords: Mobile Health
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social Support
timeFrame: Baseline, 1, 3, and 6 months.
measure: Loneliness
timeFrame: Baseline, 1, 3, and 6 months.
Secondary outcomes:
measure: Substance Use
timeFrame: Baseline, 1, 3, and 6 months.
measure: Engagement in Medications for Opioid Use Disorder (MOUD)
timeFrame: Baseline, 1, 3, and 6 months.
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Treatment Received
timeFrame: Baseline, 1, 3, and 6 months.
measure: Quality of Life
timeFrame: Baseline, 1, 3, and 6 months.
measure: Wellbeing
timeFrame: Baseline, 1, 3, and 6 months.
measure: Depressive Symptoms
timeFrame: Baseline, 1, 3, and 6 months.
measure: Anxiety Symptoms
timeFrame: Baseline, 1, 3, and 6 months.
measure: Perceived Stress
timeFrame: Baseline, 1, 3, and 6 months.
measure: Number of Days of App Use
timeFrame: 6 months
measure: Number of Messages Sent in App
timeFrame: 6 months
measure: System Usability Scale
timeFrame: 6 months
measure: Client Satisfaction Questionnaire
timeFrame: 6 months
measure: Qualitative Exit Interview
timeFrame: 6 months
measure: Number of Flagged Messages
timeFrame: 6 months
measure: Number of Crisis Interventions
timeFrame: 6 months
measure: Time Spent Onboarding App Users
timeFrame: 6 months
measure: Clinician Time Spent on Crisis Managment
timeFrame: 6 months
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: