NCT06980233

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 12, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

substance use disordermental healthcriminal-legal involvement

Outcome Measures

Primary Outcomes (6)

  • App usage

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

    From enrollment for 1.5 months during the open pilot

  • System Usability Scale (SUS)

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

    From enrollment for 1.5 months during the open pilot

  • Mobile Application Rating Scale (MARS)

    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"

    From enrollment for 1.5 months during the open pilot

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

    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.

    From enrollment for 1.5 months during the open pilot

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

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

    From enrollment for 1.5 months during the open pilot

  • Composite International Diagnostic Instrument for DSM-IV: Mental Health

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

    From enrollment for 1.5 months during the open pilot

Study Arms (1)

R-Assist

EXPERIMENTAL

Participants who have recently released from jail will engage with the R-assist app for up to 1.5 months

Behavioral: reentry assistance mobile health app

Interventions

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.

R-Assist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related DisordersMental DisordersRecidivismPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersCriminal BehaviorBehaviorPersonal Satisfaction

Study Officials

  • David Smelson, PsyD

    University of Massachusetts Chan Medical School

    PRINCIPAL INVESTIGATOR
  • Donna Surges Tatum, PhD

    Meaningful Measurement, LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Smelson, PsyD

CONTACT

Paige Shaffer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

June 1, 2025

Primary Completion

August 31, 2025

Study Completion

September 29, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share