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

NCT06896656 | Recruiting DMC

• 1 other identifier: 1R34DA058299
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Opioid Use Disorder

Keywords

Mobile Health

Outcome Measures

Primary Outcomes (2)

• Social Support

  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.

  Baseline, 1, 3, and 6 months.

• Loneliness

  Loneliness will be assessed with the 20-item UCLA Loneliness scale. Scores range from 20 to 80, where higher scores indicate greater loneliness.

  Baseline, 1, 3, and 6 months.

Secondary Outcomes (2)

• Substance Use

  Baseline, 1, 3, and 6 months.

• Engagement in Medications for Opioid Use Disorder (MOUD)

  Baseline, 1, 3, and 6 months.

Other Outcomes (16)

• Demographics

  Baseline

• Treatment Received

  Baseline, 1, 3, and 6 months.

• Quality of Life

  Baseline, 1, 3, and 6 months.

Study Arms (2)

MPS App

EXPERIMENTAL

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.

Behavioral: Marigold Mobile Peer Support Intervention

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Resources

Interventions

Marigold Mobile Peer Support Intervention 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.

MPS App

Resources 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.

Enhanced Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Kirsten J Langdon, PhD

CONTACT

4016064198; kirsten.langdon@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 26, 2025
• Study Start: March 17, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)