Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

NCT05852015 | Completed DMC

• 2 other identifiers: 20000285371K23AT011342-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (6)

• 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

Other Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Treatment-as-Usual (TAU)

ACTIVE COMPARATOR

TAU consists of weekly outpatient-based group therapy

Behavioral: Treatment-as-Usual (TAU)

TAU Plus Digital Mindfulness-Based Treatment

EXPERIMENTAL

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); Behavioral: Digital Mindfulness Treatment

Interventions

Treatment-as-Usual (TAU) BEHAVIORAL

TAU consists of weekly outpatient-based group therapy for substance use disorder

TAU Plus Digital Mindfulness-Based Treatment; Treatment-as-Usual (TAU)

Digital Mindfulness Treatment BEHAVIORAL

The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder

TAU Plus Digital Mindfulness-Based Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

1 Church street

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 10, 2023
• Study Start: May 18, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)