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OpenTrials
Active, Not Recruiting

NCT Number: NCT06980233

Reentry Assist (R-Assist)

This project will aim to develop and pilot test, R-Assist, a mobile health application to support individuals with co-occurring substance use and mental health disorders (COD) in their recovery, who have recently released from a participating Massachusetts jail.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Substance Use Disorder (SUD) Behavior Chemically-Induced Disorders Criminal Behavior Criminal Recidivism Mental Disorders Mental Health Disorder Personal Satisfaction Psychological Well-Being Recidivism Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

About this study

This Phase I project will develop and test an mHealth app called R-Assist among individuals with COD recently released from a Massachusetts jail. R-Assist will offer four core features, including linkages to community resources via the resource locator, on demand, tailored self-help materials, and self-management/organizational tools. The following two Aims will be tested: Aim 1. R-Assist software and content prototype development. The 4 R-Assist features will include: 1) daily self-reported symptom and medication management monitoring; 2) a 29-session self-help curriculum, with an accompanying library of recovery resources to support COD symptom management and promote prosocial thinking and behavior; 3) social determinants of health (SDOH) resource finder; and 4) a dashboard to track R-Assist engagement. Aim 2. A successive cohort study of the R-Assist prototype with participants who have recently left jail (N = 38). This will include three successive field focus group cohorts with 18 participants, followed by a small open pilot with 20 participants. This project's four milestones will be executed in preparation for a larger Phase II trial.

  • Milestone 1 (Months 1-5): R-Assist App Development and Interface Designs

o No human subjects involvement

  • Milestone 2 (Months 6-7): Initial Evaluation/Refinement of R-Assist

o To recruit N=18 individuals for this Milestone

  • Milestone 3 (Months 8-10): Open Pilot of R-Assist

o To recruit recruit N=20 individuals for this Milestone

  • Milestone 4 (Months 11-12): Product Refinement Prior to Phase II and Dissemination o No human subjects involvement

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have been released from the participating jail within the past 150 days
  • Own a smartphone (Android or iOS; 90% met this criterion in our prior studies)
  • Have COD: any substance use disorder (we will allow poly-substance use disorders) and a co-occurring mental health disorder (depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia)
  • Consent to R-Assist app use observation and e-tracking
  • Consent to audio recording during interviews and focus groups.

Exclusion criteria

  • Acutely suicidal, homicidal, or psychotic
  • Unable to provide informed consent
  • Individuals released with monitoring devices or individuals involved in drug treatment courts

Treatment and study plan

reentry assistance mobile health app

Behavioral

R-Assist features will include: 1) daily self-reported symptom and medication management monitoring; 2) a 29-session MISSION-CJ self-help curriculum, with an accompanying library of recovery resources to support COD symptom management and promote prosocial thinking and behavior; 3) SDOH resource finder; and 4) a dashboard to track R-Assist engagement.

Primary outcomes

  1. App usage

    Time frame: From enrollment for 1.5 months during the open pilot

    Total time engaged in app will be tracked daily during open pilot period. Additionally, engagement and time with each feature will be tracked

  2. System Usability Scale (SUS)

    Time frame: From enrollment for 1.5 months during the open pilot

    Overall score will be computed, indicating overall usability Score ranges from 0-100 (0-64=not acceptable, 65-84=acceptable, and 85, 100=excellent.

  3. Mobile Application Rating Scale (MARS)

    Time frame: From enrollment for 1.5 months during the open pilot

    Overall score will be computed, indicating overall acceptability, as well as score for each of the four dimensions. The rating scale assesses app quality on four dimensions (1. Engagement, 2. Functionality, 3. Aesthetics, and 4. Information). All items are rated on 5-point scale from "1=inadequate" to "5=excellent"

  4. Composite International Diagnostic Instrument for DSM-IV: Social determinants of health (SDOH) linkages

    Time frame: From enrollment for 1.5 months during the open pilot

    SDOH needs (e.g., housing instability, food insecurity, NA/AA/ other recovery linkages) will be assessed and the App will track all referrals and SDOH linkages made. Percent of linkages made to needed SDOH services will be examined.

  5. Composite International Diagnostic Instrument for DSM-IV: Substance Use Disorder

    Time frame: From enrollment for 1.5 months during the open pilot

    Substance use disorder symptoms will be tracked daily during the open pilot period.

  6. Composite International Diagnostic Instrument for DSM-IV: Mental Health

    Time frame: From enrollment for 1.5 months during the open pilot

    Mental health symptoms will be tracked daily during the open pilot period.

Sponsors and collaborators

Lead sponsor

Meaningful Measurement, Inc

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Massachusetts, Worcester

Registry information

Official study title

Reentry-Assist App Development for Individuals With Addiction and Mental Illness

Acronym: R-Assist

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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