Clinical trial NCT05852015: Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery
Official title: Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-05-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adherence to the digital treatment
timeFrame: 8-week treatment period that begins on the day participants are randomized
measure: Completion rates for the post-treatment assessment visit
timeFrame: Approximately 9 weeks after randomization
measure: Completion rates for the follow-up assessment visit
timeFrame: 2-month post-treatment follow-up (approximately 16 weeks post-randomization)
measure: Completion rates for ecological momentary assessment at baseline
timeFrame: 2-week period at baseline prior to randomization
measure: Completion rates for ecological momentary assessment at post-treatment
timeFrame: 2-week period occurring approximately during weeks 10 and 11 post-randomization
measure: Dimensions of treatment acceptability
timeFrame: Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization
Secondary outcomes:
Other outcomes:
measure: Change in frequency of primary substance use
timeFrame: 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)
measure: Change in frequency of any substance use
timeFrame: 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)
measure: Change in substance-related problems
timeFrame: 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)
Locations:
city: New Haven
country: United States
facility: 1 Church street
state: Connecticut
Study officials:
References: