Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City
22 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
300
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hannah Szlyk
- Número de teléfono: 917-836-4225
- Correo electrónico: szlyk@wustl.edu
Copia de seguridad de contactos de estudio
- Nombre: Elecia Worley
- Correo electrónico: e.m.worley@wustl.edu
Ubicaciones de estudio
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Reclutamiento
- Washington University School of Medicine
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Contacto:
- Hannah Szlyk, PhD
- Número de teléfono: 917-836-4225
- Correo electrónico: szlyk@wustl.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Abstinence/ Changes in Substance Use
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depression symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Client/User Experience
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de agosto de 2025
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
28 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
29 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202308065
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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