Mindfulness-Based Relapse Prevention for Methadone Maintenance

Substance-Related Disorders Clinical Trial

Official title:

Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882125
• Other study ID #: MBRP for MMT
• Status: Completed
• Phase: N/A
• Start date: February 15, 2015
• Est. completion date: June 27, 2015

Study information

• Verified date: March 2019
• Source: Pacific University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study was designed to inform protocol adaptation, and to evaluate the feasibility, acceptability, and preliminary efficacy of a mindfulness-based intervention for methadone maintenance clients. Adults (N=15) were recruited from a methadone clinic to participate in a 6-week mindfulness course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within this client population.

Description:

As rates of opiate misuse rise in the United States, there areso do significant associated health, and financial consequences to afflicted individuals, their families, and society at large. Methadone Maintenance Therapy (MMT) is one evidence-based approach to treating individuals with opiate addiction, yet supplemental psychosocial treatment to support this approach is lacking. Mindfulness-Based Relapse Prevention (MBRP) has shown to be efficacious in various substance use populations, but has yet to be assessed with MMT clients. The current study was designed to inform protocol adaptation for to MMT clients, and to evaluate the feasibility, acceptability, and preliminary efficacy of a MBRP for this population. The sample consisted of adults (N=15) recruited from a methadone clinic to participate in a 6-week MBRP course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included self-compassion, depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results from this initial pilot support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within the MMT community.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 27, 2015
• Est. primary completion date: June 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clearance from clinic staff

• Currently enrolled in a methadone maintenance program

• Agree to complete assessment questionnaires and attend treatment sessions

• Fluent in English

Exclusion Criteria:

• Indication of active psychosis

• Participation in past mindfulness-based relapse prevention group

Related Conditions & MeSH terms

• Recurrence
• Substance-Related Disorders

Intervention

Behavioral:
• Mindfulness-based relapse prevention
Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pacific University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability - Satisfaction with the Course	Satisfaction with the course will be assessed using the Overall Course Satisfaction Survey, items #1-4 (Bowen, Chawla, & Marlatt, 2010). This is a self-report questionnaire, the first 4 items of which are open-ended questions assessing satisfaction with the course, barriers to learning, and perceived helpfulness.	post course (6 weeks)
Primary	Acceptability - Enactment of Learned Skills	Enactment will be assessed using the Overall Course Satisfaction Survey, items #5-7 (Bowen, Chawla, & Marlatt, 2010). This is a self-report questionnaire, the last 3 questions of which are 10-point Likert-type items, and assess importance of skills and likelihood of implementing them into daily life after the course ends. Higher scores indicate higher perceived importance and likelihood.	post course (6 weeks)
Secondary	Depression	Depression symptoms will be assessed using the Beck Depression Inventory-II, a 21-item self report measure. Items are summed for a total score ranging from 0-63. A score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	1 month
Secondary	Anxiety	Anxiety symptoms will be assessed using the Beck Anxiety Inventory, a 21-item self report measure. Items are summed for a total score that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a Minimal anxiety, 8 - 15 as Mild, 16 - 25 as Moderate, and 26 - 63 as Severe.	1 month
Secondary	Craving	Craving for substances will be assessed using the Penn Alcohol Craving Scale, a five-item Likert-scaled measure assessing frequency, intensity, duration, and overall levels of craving, adapted to include both alcohol and drugs. Each question is scaled from 0 to 6. Sum scores range from 0-30, with greater scores indicating higher craving.	1 month
Secondary	Trauma symptoms	PTSD symptoms will be assessed using the Post-Traumatic Stress Disorder Checklist-Civilian (PCL-C), which measures presence and severity of trauma symptoms using 16-item Likert-scaled questionnaire.	1 month
Secondary	Experiential avoidance	The Acceptance and Action Questionnaire (AAQ) is a widely used measure of experiential avoidance and psychological inflexibility consisting of nine Likert-scaled items, answer options ranging from 1 (never true) to 7 (always true). High scores reflect greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.	1 month