Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City
22 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Studietype
Ingrijpend
Inschrijving (Geschat)
300
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Hannah Szlyk
- Telefoonnummer: 917-836-4225
- E-mail: szlyk@wustl.edu
Studie Contact Back-up
- Naam: Elecia Worley
- E-mail: e.m.worley@wustl.edu
Studie Locaties
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Missouri
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University School of Medicine
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Contact:
- Hannah Szlyk, PhD
- Telefoonnummer: 917-836-4225
- E-mail: szlyk@wustl.edu
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Abstinence/ Changes in Substance Use
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Depression symptoms
Tijdsspanne: 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
Tijdsspanne: Time 0 (Baseline) and Time 1 (One-Month)
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Client/User Experience
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 augustus 2025
Primaire voltooiing (Geschat)
31 december 2026
Studie voltooiing (Geschat)
28 februari 2027
Studieregistratiedata
Eerst ingediend
17 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 juni 2026
Eerst geplaatst (Werkelijk)
29 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
22 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202308065
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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