Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City
22 juni 2026 uppdaterad av: Washington University School of Medicine
Leveraging mHealth to Promote Recovery From Opioid Use Disorder and Commonly Occurring Mental Health Disorders 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.
Studieöversikt
Status
Rekrytering
Studietyp
Interventionell
Inskrivning (Beräknad)
300
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hannah Szlyk
- Telefonnummer: 917-836-4225
- E-post: szlyk@wustl.edu
Studera Kontakt Backup
- Namn: Elecia Worley
- E-post: e.m.worley@wustl.edu
Studieorter
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Missouri
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St Louis, Missouri, Förenta staterna, 63110
- Rekrytering
- Washington University School of Medicine
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Kontakt:
- Hannah Szlyk, PhD
- Telefonnummer: 917-836-4225
- E-post: szlyk@wustl.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: uMAT-R + enhanced community engagement
uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team.
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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.
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Aktiv komparator: Original uMAT-R supplementary mHealth recovery intervention
uMAT-R supplementary mHealth recovery intervention is the original intervention disseminated without optimization of the community engagement approach.
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uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Abstinence/ Changes in Substance Use
Tidsram: Time 0 (Baseline) and Time 1 (One Month)
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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.
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Time 0 (Baseline) and Time 1 (One Month)
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Opioid use/ Stimulant use disorder symptoms
Tidsram: Time 0 (Baseline) and Time 1 (One Month)
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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.
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Time 0 (Baseline) and Time 1 (One Month)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Depression symptoms
Tidsram: 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.
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Time 0 (Baseline) and Time 1 (One-Month)
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Anxiety Symptoms
Tidsram: 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.
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Time 0 (Baseline) and Time 1 (One-Month)
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Basic needs
Tidsram: Time 0 (Baseline) and Time 1 (One-Month)
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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.
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Time 0 (Baseline) and Time 1 (One-Month)
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Medication for Opioid Use Disorder (MOUD) Attitudes
Tidsram: Time 0 (Baseline), and Time 1 (One-Month)
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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.
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Time 0 (Baseline), and Time 1 (One-Month)
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Substance Use Disorder (SUD) Treatment Engagement
Tidsram: Time 0 (Baseline), and Time 1 (One-Month)
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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 0 (Baseline), and Time 1 (One-Month)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Client/User Experience
Tidsram: Time 1 (One-Month)
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Participants discuss ease of use and learning, usefulness, and likability of using uMAT-R, and their overall experience pursuing substance use recovery.
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Time 1 (One-Month)
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uMAT-R App Engagement
Tidsram: From Time 0 to Time 1
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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).
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From Time 0 to Time 1
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uMAT-R E-coach Engagement
Tidsram: Time 0 to Time 1
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Will be assessed by whether participants sent at least one message to the e-coach and the outcome will be binary (yes/no).
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Time 0 to Time 1
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 augusti 2025
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
28 februari 2027
Studieregistreringsdatum
Först inskickad
17 juni 2026
Först inskickad som uppfyllde QC-kriterierna
22 juni 2026
Första postat (Faktisk)
29 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202308065
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