Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

NCT ID: NCT05852015

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Treatment-as-Usual (TAU)

TAU consists of weekly outpatient-based group therapy

Group Type ACTIVE_COMPARATOR

Treatment-as-Usual (TAU)

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Treatment-as-Usual (TAU)

Intervention Type BEHAVIORAL

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

Digital Mindfulness Treatment

Intervention Type BEHAVIORAL

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

Interventions

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Treatment-as-Usual (TAU)

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Corey Roos

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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1 Church street

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1K23AT011342-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000028537

Identifier Type: -

Identifier Source: org_study_id

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