Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852015
• Other study ID #: 2000028537
• Secondary ID: 1K23AT011342-01
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Corey Roos
• Phone: 2036235882
• Email: corey.roos[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Treatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy for substance use disorder
• Digital Mindfulness Treatment
The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder

Locations

Country	Name	City	State
United States	1 Church street	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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
Primary	Completion rates for the post-treatment assessment visit	Percent of randomized participants completing post-treatment assessment visit	Approximately 9 weeks after randomization
Primary	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)
Primary	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
Primary	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
Primary	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