Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

Not Applicable

Completed

• Conditions: Substance Use Disorders
• Interventions: Behavioral: Treatment-as-Usual (TAU); Behavioral: Digital Mindfulness Treatment

• Registration Number: NCT05852015
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-30
• Study First Posted: 2023-05-10
• Study Start: 2023-05-18
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-as-Usual (TAU)	Treatment-as-Usual (TAU)	TAU consists of weekly outpatient-based group therapy
TAU Plus Digital Mindfulness-Based Treatment	Digital Mindfulness Treatment	TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
TAU Plus Digital Mindfulness-Based Treatment	Treatment-as-Usual (TAU)	TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.

Primary Outcome Measures

Name	Time	Method
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 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 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
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 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
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.

Trial Locations

Locations (1)

1 Church street; 🇺🇸 New Haven, Connecticut, United States