Clinical Trials Directory

Trials / Completed

CompletedNCT04278352

Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

Randomized Controlled Trial of Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Clemson University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Detailed description

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. Participants will be recruited from outpatient medical clinics and substance use recovery centers. They will be assigned to an intervention group (Group 1) or waitlist control (Group 2), completing assessments at baseline, 8, and 16 weeks. Group 1 will receive the intervention in weeks 1-8 and group 2 will receive the intervention in weeks 9-16. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness Based Relapse PreventionThe intervention is a group skills training program that is delivered once weekly for eight weeks. Content focuses on mindfulness and cognitive-behavioral relapse prevention skills, including psychoeducation, experiential exercises, and between session homework assignments.

Timeline

Start date
2020-07-01
Primary completion
2023-08-01
Completion
2023-08-01
First posted
2020-02-20
Last updated
2024-03-08

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04278352. Inclusion in this directory is not an endorsement.