Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Substance Use Disorders
- Sponsor
- Yale University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Adherence to the digital treatment
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Corey Roos
Assistant Professor of Psychiatry
Yale University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adherence to the digital treatment
Time Frame: 8-week treatment period that begins on the day participants are randomized
Percent of randomized participants completing 50% or more of the digital treatment modules
Completion rates for the follow-up assessment visit
Time Frame: 2-month post-treatment follow-up (approximately 16 weeks post-randomization)
Percent of randomized participants completing follow-up assessment visit
Completion rates for ecological momentary assessment at post-treatment
Time Frame: 2-week period occurring approximately during weeks 10 and 11 post-randomization
Percent of randomized participants completing 50% or more of EMA surveys post-treatment
Completion rates for the post-treatment assessment visit
Time Frame: Approximately 9 weeks after randomization
Percent of randomized participants completing post-treatment assessment visit
Completion rates for ecological momentary assessment at baseline
Time Frame: 2-week period at baseline prior to randomization
Percent of randomized participants completing 50% or more of EMA surveys at baseline
Dimensions of treatment acceptability
Time Frame: Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization
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.