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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07673380
Enrollment
300
Registered
2026-06-29
Start date
2025-08-31
Completion date
2027-02-28
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and Anxiety Symptoms, Opioid Use, Stimulant Use

Keywords

Digital health, Community engagement

Brief summary

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.

Interventions

BEHAVIORALuMAT-R + enhanced community engagement

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.

BEHAVIORALOriginal uMAT-R supplementary mHealth recovery intervention

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

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Abstinence/ Changes in Substance UseTime 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.
Opioid use/ Stimulant use disorder symptomsTime 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

MeasureTime frameDescription
Depression symptomsTime 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.
Anxiety SymptomsTime 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.
Basic needsTime 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.
Medication for Opioid Use Disorder (MOUD) AttitudesTime 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.
Substance Use Disorder (SUD) Treatment EngagementTime 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."

Countries

United States

Contacts

CONTACTHannah Szlyk
szlyk@wustl.edu917-836-4225
CONTACTElecia Worley
e.m.worley@wustl.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026