Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

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

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Treatment-as-Usual (TAU); Behavioral: Digital Mindfulness Treatment

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • 1 Church street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Digital Treatment	Number of randomized participants completing 50% or more of the digital treatment modules. This outcome was only assessed in the digital mindfulness arm.	8-week treatment period that begins on the day participants are randomized
Completion Rates for the Post-treatment Assessment Visit	Percentage of participants that completed post-treatment assessment visit of all randomized participants	Approximately 9 weeks after randomization
Completion Rates for the 2-month Follow-up Assessment Visit	Percentage of participants that completed 2-month post-treatment assessment visit of all randomized participants	2-month post-treatment follow-up (approximately 16 weeks post-randomization)
Completion Rates for Ecological Momentary Assessment at Baseline	Percentage of participants that completed 50% or more of EMA surveys at baseline of all randomized participants	2-week period at baseline prior to randomization
Completion Rates for Ecological Momentary Assessment Post-treatment	Percentage of participants that completed 50% or more of EMA surveys post-treatment of all randomized participants	Post-treatment 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percent Days of Any Substance Use	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.	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)
Change in Percent Days of Primary Substance Use	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.	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	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.	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 Brief Symptom Inventory (BSI) Score	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.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of primary substance use	The Timeline Follow Back, a calendar-based interview, will be used to assess 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	The Timeline Follow Back, a calendar-based interview, will be used to assess 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	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.	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)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 30, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2000028537; 1K23AT011342-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No