Mindfulness-Based Relapse Prevention for Methadone Maintenance

NCT ID: NCT03882125

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-15

Study Completion Date

2015-06-27

Brief Summary

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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

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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.

Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness

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

Group Type EXPERIMENTAL

Mindfulness-based relapse prevention

Intervention Type BEHAVIORAL

Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches

Interventions

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Mindfulness-based relapse prevention

Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacific University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Bowen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MBRP for MMT

Identifier Type: -

Identifier Source: org_study_id

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