Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment-as-Usual (TAU) TAU consists of weekly outpatient-based group therapy |
Behavioral: Treatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy for substance use disorder
|
| Experimental: TAU Plus Digital Mindfulness-Based Treatment 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)
TAU consists of weekly outpatient-based group therapy for substance use disorder
Behavioral: Digital Mindfulness Treatment
The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder
|
Outcome Measures
Primary Outcome Measures
- Adherence to the digital treatment [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 post-treatment assessment visit [Approximately 9 weeks after randomization]
Percent of randomized participants completing post-treatment assessment visit
- Completion rates for the follow-up assessment visit [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 baseline [2-week period at baseline prior to randomization]
Percent of randomized participants completing 50% or more of EMA surveys at baseline
- Completion rates for ecological momentary assessment at post-treatment [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
- Dimensions of treatment acceptability [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.
Other Outcome Measures
- Change in frequency of primary substance use [Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)]
The Timeline Follow Back, a calendar-based interview, will be used to assess substance use
- Change in frequency of any substance use [Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)]
The Timeline Follow Back, a calendar-based interview, will be used to assess substance use
- Change in substance-related problems [Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)]
Short-inventory of problems Revised (SIP-R), a self-report questionnaire of substance-related problems. Total score range from 0 to 51, with higher scores indicating greater substance related problems.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Yale University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000028537