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Mindfulness-Based Relapse Prevention for Methadone Maintenance

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-based relapse prevention
Sponsored by
Pacific University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring mindfulness, methadone maintenance, relapse prevention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mindfulness

    Arm Description

    Assigned to a 6-week mindfulness-based relapse prevention course

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    April 3, 2017
    Last Updated
    March 18, 2019
    Sponsor
    Pacific University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03882125
    Brief Title
    Mindfulness-Based Relapse Prevention for Methadone Maintenance
    Official Title
    Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 15, 2015 (Actual)
    Primary Completion Date
    June 27, 2015 (Actual)
    Study Completion Date
    June 27, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pacific University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance-Related Disorders
    Keywords
    mindfulness, methadone maintenance, relapse prevention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness
    Arm Type
    Experimental
    Arm Description
    Assigned to a 6-week mindfulness-based relapse prevention course
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-based relapse prevention
    Intervention Description
    Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches
    Primary Outcome Measure Information:
    Title
    Acceptability - Satisfaction with the Course
    Description
    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.
    Time Frame
    post course (6 weeks)
    Title
    Acceptability - Enactment of Learned Skills
    Description
    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.
    Time Frame
    post course (6 weeks)
    Secondary Outcome Measure Information:
    Title
    Depression
    Description
    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.
    Time Frame
    1 month
    Title
    Anxiety
    Description
    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.
    Time Frame
    1 month
    Title
    Craving
    Description
    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.
    Time Frame
    1 month
    Title
    Trauma symptoms
    Description
    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.
    Time Frame
    1 month
    Title
    Experiential avoidance
    Description
    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.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Mindfulness-Based Relapse Prevention for Methadone Maintenance

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