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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Self-reported cognitive impairment that would limit ability to participate in research.

Trial design

Design model

Sequential

Treatments tested in this trial

  • uMAT-R + enhanced community engagement

    Behavioral

    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.

  • Original uMAT-R supplementary mHealth recovery intervention

    Behavioral

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: uMAT-R + enhanced community engagementExperimental treatment 1 intervention
Group B: Original uMAT-R supplementary mHealth recovery interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Abstinence/ Changes in Substance Use

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 frame
Time 0 (Baseline) and Time 1 (One Month)
2

Opioid use/ Stimulant use disorder symptoms

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 frame
Time 0 (Baseline) and Time 1 (One Month)

Secondary outcomes

1

Depression symptoms

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 frame
Time 0 (Baseline) and Time 1 (One-Month)
2

Anxiety Symptoms

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 frame
Time 0 (Baseline) and Time 1 (One-Month)
3

Basic needs

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 frame
Time 0 (Baseline) and Time 1 (One-Month)
4

Medication for Opioid Use Disorder (MOUD) Attitudes

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 frame
Time 0 (Baseline), and Time 1 (One-Month)

Other outcomes

1

Client/User Experience

Participants discuss ease of use and learning, usefulness, and likability of using uMAT-R, and their overall experience pursuing substance use recovery.

Time frame
Time 1 (One-Month)
2

uMAT-R App Engagement

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).

Time frame
From Time 0 to Time 1
3

uMAT-R E-coach Engagement

Will be assessed by whether participants sent at least one message to the e-coach and the outcome will be binary (yes/no).

Time frame
Time 0 to Time 1

Sponsors and contacts

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