A Phase 2 interventional study of uMAT-R + enhanced community engagement and Original uMAT-R supplementary mHealth recovery intervention in Opioid Use, Stimulant Use and Depression and Anxiety Symptoms, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Supportive care
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 300 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team.
Behavioral: uMAT-R + enhanced community engagement
uMAT-R supplementary mHealth recovery intervention is the original intervention disseminated without optimization of the community engagement approach.
Behavioral: Original uMAT-R supplementary mHealth recovery intervention
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.
uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.
Abstinence/ Changes in Substance Use
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.
Time frame: Time 0 (Baseline) and Time 1 (One Month)
Opioid use/ Stimulant use disorder symptoms
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.
Time frame: Time 0 (Baseline) and Time 1 (One Month)
Depression symptoms
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.
Time frame: Time 0 (Baseline) and Time 1 (One-Month)
Anxiety Symptoms
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.
Time frame: Time 0 (Baseline) and Time 1 (One-Month)
Basic needs
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.
Time frame: Time 0 (Baseline) and Time 1 (One-Month)
Medication for Opioid Use Disorder (MOUD) Attitudes
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.
Time frame: Time 0 (Baseline), and Time 1 (One-Month)
Substance Use Disorder (SUD) Treatment Engagement
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."
Time frame: Time 0 (Baseline), and Time 1 (One-Month)
Client/User Experience
Participants discuss ease of use and learning, usefulness, and likability of using uMAT-R, and their overall experience pursuing substance use recovery.
Time frame: Time 1 (One-Month)
uMAT-R App Engagement
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).
Time frame: From Time 0 to Time 1
uMAT-R E-coach Engagement
Will be assessed by whether participants sent at least one message to the e-coach and the outcome will be binary (yes/no).
Time frame: Time 0 to Time 1
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