Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.

Official Title
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Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Behavioral: Treatment-as-Usual (TAU)
* Behavioral: Digital Mindfulness Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Fluent in English and have a 6th grade or higher reading level Have completed 1 month or more of SUD treatment Report use of their primary substance of choice in past 6 months Are not currently enrolled in residential/inpatient treatment Are willing to be randomized Are willing and able to participate for the entire study period Are willing to provide locator information for follow-up Own a working, WIFI-enabled smartphone Exclusion Criteria: Current psychotic disorder High suicide risk characterized by suicidal ideation with intent Homicidal ideation posing imminent danger to others Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period Participation in the Phase 1 User Testing study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment-as-Usual (TAU)<br>TAU consists of weekly outpatient-based group therapy | Behavioral: Treatment-as-Usual (TAU)<br>* TAU consists of weekly outpatient-based group therapy for substance use disorder<br>|
| Experimental: TAU Plus Digital Mindfulness-Based Treatment<br>TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills. | Behavioral: Treatment-as-Usual (TAU)<br>* TAU consists of weekly outpatient-based group therapy for substance use disorder<br>Behavioral: Digital Mindfulness Treatment<br>* The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the digital treatment | Percent of randomized participants completing 50% or more of the digital treatment modules | 8-week treatment period that begins on the day participants are randomized | 
| Completion rates for the post-treatment assessment visit | Percent of randomized participants completing post-treatment assessment visit | Approximately 9 weeks after randomization | 
| Completion rates for the follow-up assessment visit | Percent of randomized participants completing follow-up assessment visit | 2-month post-treatment follow-up (approximately 16 weeks post-randomization) | 
| Completion rates for ecological momentary assessment at baseline | Percent of randomized participants completing 50% or more of EMA surveys at baseline | 2-week period at baseline prior to randomization | 
| Completion rates for ecological momentary assessment at post-treatment | Percent of randomized participants completing 50% or more of EMA surveys post-treatment | 2-week period occurring approximately during weeks 10 and 11 post-randomization | 
| Dimensions of treatment acceptability | Single-items measuring ratings of acceptability dimensions for the digital treatment, including willingness to engage, usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability. | Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization |