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

22. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: uMAT-R + enhanced community engagement
uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team.
Adfærdsmæssigt: uMAT-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.
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.
Adfærdsmæssigt: Original uMAT-R supplementary mHealth recovery intervention
uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Abstinence/ Changes in Substance Use
Tidsramme: 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.
Time 0 (Baseline) and Time 1 (One Month)
Opioid use/ Stimulant use disorder symptoms
Tidsramme: 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.
Time 0 (Baseline) and Time 1 (One Month)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression symptoms
Tidsramme: 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.
Time 0 (Baseline) and Time 1 (One-Month)
Anxiety Symptoms
Tidsramme: 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.
Time 0 (Baseline) and Time 1 (One-Month)
Basic needs
Tidsramme: 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.
Time 0 (Baseline) and Time 1 (One-Month)
Medication for Opioid Use Disorder (MOUD) Attitudes
Tidsramme: 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.
Time 0 (Baseline), and Time 1 (One-Month)
Substance Use Disorder (SUD) Treatment Engagement
Tidsramme: 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."
Time 0 (Baseline), and Time 1 (One-Month)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Client/User Experience
Tidsramme: 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.
Time 1 (One-Month)
uMAT-R App Engagement
Tidsramme: 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).
From Time 0 to Time 1
uMAT-R E-coach Engagement
Tidsramme: 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).
Time 0 to Time 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. august 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202308065

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Opioidbrug

Kliniske forsøg med uMAT-R + enhanced community engagement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner