NCT03882125

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
2 years until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

April 3, 2017

Last Update Submit

March 18, 2019

Conditions

Keywords

mindfulnessmethadone maintenancerelapse prevention

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (5)

  • Depression

    1 month

  • Anxiety

    1 month

  • Craving

    1 month

  • Trauma symptoms

    1 month

  • Experiential avoidance

    1 month

Study Arms (1)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness-based relapse prevention

Interventions

Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches

Mindfulness

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clearance from clinic staff
  • Currently enrolled in a methadone maintenance program
  • Agree to complete assessment questionnaires and attend treatment sessions
  • Fluent in English

You may not qualify if:

  • Indication of active psychosis
  • Participation in past mindfulness-based relapse prevention group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

March 20, 2019

Study Start

February 15, 2015

Primary Completion

June 27, 2015

Study Completion

June 27, 2015

Last Updated

March 20, 2019

Record last verified: 2019-03