Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

Yale University

Status: Completed

Conditions: Substance Use Disorders

Treatments: Behavioral: Treatment-as-Usual (TAU); Behavioral: Digital Mindfulness Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05852015

2000028537

1K23AT011342-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Treatment-as-Usual (TAU)

Active Comparator group

Description:

TAU consists of weekly outpatient-based group therapy

Treatment:

Behavioral: Treatment-as-Usual (TAU)

TAU Plus Digital Mindfulness-Based Treatment

Experimental group

Description:

TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.

Treatment:

Behavioral: Digital Mindfulness Treatment

Behavioral: Treatment-as-Usual (TAU)