Randomized Controlled Trial of Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid-use Disorder
- Sponsor
- Clemson University
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Change in frequency of opioid/alcohol use
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Heidi Zinzow
Professor
Clemson University
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
- •moderate to severe traumatic brain injury
- •pregnancy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in frequency of opioid/alcohol use
Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Frequency and time to first use will be assessed with both self-timeline follow-back method and collateral timeline follow-back for the past 60 days (Wray et al 2016; Donohue et al., 2004), as well as urine samples.
Change in opioid/alcohol craving
Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
We will assess craving with the Penn Alcohol Craving Scale, which will be modified to assess opioid craving for individuals with opioid use disorder (Garland et al., 2014; Flannery, Volpicelli, \& Pettinati, 1999). The Penn Scale is a 5 item self-report measure with scores ranging from 0 to 30, with higher scores indicating higher levels of craving.
Change in quality of life: World Health Organization Quality of Life (WHOQOL)-BREF
Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Quality of life will be assessed with the World Health Organization Quality of Life (WHOQOL)-BREF. The WHOQOL-BREF is a 26 item self-report measure that assesses four domains: physical health, psychological, social relationships, and environment. Transformed scores range from 0 to 100 for each of the four domains, with higher scores indicating greater quality of life.
Change in withdrawal symptoms
Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Assessed with The Short Opiate Withdrawal Scale (Gossop, 1990) and the Short Alcohol Withdrawal Scale (Gossop et al., 2002). The Short Opiate Withdrawal Scale and the Short Alcohol Withdrawal Scale are each10 item self-report scales, with scores ranging from 0 to 30, with higher scores indicating more withdrawal symptoms.
Secondary Outcomes
- Change in posttraumatic stress symptoms(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in medication adherence(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in executive functioning(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in pain severity: Brief Pain Inventory(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in mindfulness skills(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in emotion regulation skills(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in perceived stress(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in Savoring(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
- Change in positive and negative affect(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))