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Completed

NCT Number: NCT05852015

Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1 Church street

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment-as-Usual (TAU)

Behavioral

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

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

Primary outcomes

  1. Adherence to the Digital Treatment

    Time frame: 8-week treatment period that begins on the day participants are randomized

    Number of randomized participants completing 50% or more of the digital treatment modules. This outcome was only assessed in the digital mindfulness arm.

  2. Completion Rates for the Post-treatment Assessment Visit

    Time frame: Approximately 9 weeks after randomization

    Percentage of participants that completed post-treatment assessment visit of all randomized participants

  3. Completion Rates for the 2-month Follow-up Assessment Visit

    Time frame: 2-month post-treatment follow-up (approximately 16 weeks post-randomization)

    Percentage of participants that completed 2-month post-treatment assessment visit of all randomized participants

  4. Completion Rates for Ecological Momentary Assessment at Baseline

    Time frame: 2-week period at baseline prior to randomization

    Percentage of participants that completed 50% or more of EMA surveys at baseline of all randomized participants

  5. Completion Rates for Ecological Momentary Assessment Post-treatment

    Time frame: Post-treatment during weeks 10 and 11 post-randomization

    Percentage of participants that completed 50% or more of EMA surveys post-treatment of all randomized participants

  6. 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.

Secondary outcomes

  1. Change in Percent Days of Any Substance Use

    Time frame: Baseline, at end-of-treatment (end of week 8 post-randomization) and at 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. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.

  2. Change in Percent Days of Primary Substance Use

    Time frame: 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. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.

  3. Change in Substance-related Problems

    Time frame: 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. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.

  4. Change in Brief Symptom Inventory (BSI) Score

    Time frame: 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)

    BSI assesses psychiatric distress using a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Higher scores indicate more distress. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 10, 2023
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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