Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

NCT ID: NCT04278352

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-08-01

Brief 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

Opioid-use Disorder; Opioid Abuse, in Remission; Alcohol Use Disorder; Alcohol Use Disorder, in Remission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfulness Based Relapse Prevention

MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. The intervention consists of eight weekly two-hour group therapy sessions, delivered by two facilitators with 6-12 people. The experimental group will complete the intervention in weeks 1-8. They will continue treatment as usual for weeks 9-16.

Group Type: EXPERIMENTAL

Mindfulness Based Relapse Prevention

Intervention Type: BEHAVIORAL

The 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.

Control

The waitlist control group will not receive the MBRP program during weeks 1-8 and will continue treatment as usual. During weeks 9-16, the control group will receive MBRP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Based Relapse Prevention

The 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• over 18 years of age
• completed behavioral health treatment for Opioid Use Disorder (OUD) or Alcohol Use Disorder (AUD) within the previous eight weeks
• continues to be followed by a behavioral health provider
• meets DSM-5 criteria for OUD or AUD
• English fluency
• able to attend intervention sessions

Exclusion Criteria

• current psychosis
• dementia
• moderate to severe traumatic brain injury
• pregnancy
• active suicidality
• persistent antisocial behavior
• acute episode of an SUD (past two weeks)
• persistent self-injury requiring clinical management
• already completed or attending a mindfulness-based intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: collaborator

Clemson University

OTHER

Sponsor Role: lead

Responsible Party

Heidi Zinzow

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu Shi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clemson University

Locations

Clemson University

Clemson, South Carolina, United States

Prisma Health-Upstate Internal Medicine Clinic

Greenville, South Carolina, United States

Phoenix Center

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

Pro00084844

Identifier Type: -

Identifier Source: org_study_id