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NCT Number: NCT07673380

Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City

The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment. Participants are recruited from community-based substance use treatment facilities and recovery services. Participants must be adults who have or are currently using opioids and/or stimulants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Hannah Szlyk, PhD

CONTACT

[email protected]

917-836-4225

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a history of opioid and/or stimulant use
  • Identify as Black and/or African American
  • Seek treatment at local substance use treatment centers
  • Fluent in English
  • U.S. resident
  • 18 years of age or older at the time of data collection.

Exclusion criteria

  • Self-reported cognitive impairment that would limit ability to participate in research.

Treatment and study plan

uMAT-R + enhanced community engagement

Behavioral

uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. This involves in-person interactions with eligible participants and recruitment sites.

Original uMAT-R supplementary mHealth recovery intervention

Behavioral

uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.

Primary outcomes

  1. Abstinence/ Changes in Substance Use

    Time frame: Time 0 (Baseline) and Time 1 (One Month)

    Frequency of opioid use, stimulant, and/or other substance use (e.g., discordant with prescribed usage) or other substances (e.g., stimulants, other non-opioid illicit drugs) in the past 30-day will be assessed by items from the National Survey on Drug Use and Health (NSDUH) questionnaire. The score indicates days on using any substance listed above over past 30-day, ranging from 0 to 30, with a higher score reflecting more frequent substance use.

  2. Opioid use/ Stimulant use disorder symptoms

    Time frame: Time 0 (Baseline) and Time 1 (One Month)

    The number of DSM-5-TR diagnostic criteria met for opioid use disorder (OUD) and stimulant use disorder (StUD) will be assessed. Scores range from 0 to 11, with higher scores indicating that more diagnostic criteria are met for the disorder.

Secondary outcomes

  1. Depression symptoms

    Time frame: Time 0 (Baseline) and Time 1 (One-Month)

    The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression symptoms. The potential scale scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Continuous variables will be created to assess the total scores at baseline and the 1-month follow-up, respectively.

  2. Anxiety Symptoms

    Time frame: Time 0 (Baseline) and Time 1 (One-Month)

    The Generalized Anxiety Disorder Assessment-7 (GAD-7) will be used to assess anxiety symptoms. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), allowing for a comprehensive evaluation of anxiety symptoms in the past 2 weeks, such as 'Feeling nervous, anxious, or on edge' or 'Becoming easily annoyed or irritable...' The potential scale scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. To examine the changes in GAD-7 scores from baseline to the 1-month follow-up, continuous variables will be created to assess the scores at the respective time points.

  3. Basic needs

    Time frame: Time 0 (Baseline) and Time 1 (One-Month)

    The adapted Wellbeing and Basic Needs Survey will be used to assess confidence in meeting their basic needs. Participants were asked to rate their confidence in meeting their basic needs on a Likert scale ranging from "very confident" (1) to "not confident at all" (8). To examine changes in scores continuous variables were created to capture the baseline and 1-month follow-up scores, respectively. Scores may range from 8 to 64, which higher scores indicating less confidence in attending to basic needs.

  4. Medication for Opioid Use Disorder (MOUD) Attitudes

    Time frame: Time 0 (Baseline), and Time 1 (One-Month)

    We will measure Medication for Opioid Use Disorder (MOUD) attitudes using an 8-item subscale to evaluate participants' attitudes towards MOUD modified from the Attitudes of Methadone Scale. Participants will provide responses on a 5-point Likert scale, ranging from 'strongly disagree' (1) to 'strongly agree' (5). Sample items include: 'Taking MOUD is only replacing one addiction with another,' 'A person is better off taking MOUD than opioids,' and 'MOUD is as dangerous as opioids.' The total score will be calculated by summing all items, resulting in a potential scoring range of 8 to 40 with higher scores indicating greater negative attitudes toward MOUD use.

  5. Substance Use Disorder (SUD) Treatment Engagement

    Time frame: Time 0 (Baseline), and Time 1 (One-Month)

    Participants will be asked if they are enrolled and receive specialty substance use care, and/or medication for Opioid Use Disorder, assessed by self-report. "Are you currently enrolled in a treatment plan or program for substance use care?" "Are you currently being prescribed medication for opioid use disorder (MOUD)"

    Response options will include "yes" or "no." If a participant responds "yes" to at least one question, the final outcome for substance use treatment engagement will be coded as "yes." "No" responses to both questions will be coded as "No."

Other outcomes

  1. Client/User Experience

    Time frame: Time 1 (One-Month)

    Participants discuss ease of use and learning, usefulness, and likability of using uMAT-R, and their overall experience pursuing substance use recovery.

  2. uMAT-R App Engagement

    Time frame: From Time 0 to Time 1

    Participants who logged into the mobile app 1 or more times during the 1 month intervention will be considered engaged in the app. The outcome will be binary (yes/no).

  3. uMAT-R E-coach Engagement

    Time frame: Time 0 to Time 1

    Will be assessed by whether participants sent at least one message to the e-coach and the outcome will be binary (yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Elecia Worley

CONTACT

[email protected]

Hannah Szlyk

CONTACT

[email protected]

917-836-4225

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Leveraging mHealth to Promote Recovery From Opioid Use Disorder and Commonly Occurring Mental Health Disorders Among Residents of a Medium-Sized Midwestern City

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 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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