Mindfulness-Based Recovery in Veterans (MBR-Veterans)

VA Office of Research and Development

Status: Completed

Conditions: Anxiety Disorder; Depression; Substance Abuse

Treatments: Behavioral: Mindfulness Based Relapse Prevention (MBRP); Behavioral: Twelve-Step Facilitation Intervention (TSF)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02326363

D1292-R

I01RX001292 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will provide important information concerning the used of mindfulness-based relapse prevention (MBRP) as a continuing care strategy for Veterans who have completed primary treatment for a SUD. Most research is focused on the acute care of SUDs, but the risk of relapse to substance use is highest during the period immediately following treatment and attention to continuing care is critical. If this trial demonstrates that MBRP promotes sustained abstinence and improved functional outcomes, this will provide a valuable treatment to facilitate rehabilitation and recovery for Veterans with SUDs.

Full description

Rates of substance use disorders (SUDS) are high among military personnel and Veterans. While much research is focused on the acute care of SUDs, the risk of relapse to substance use following treatment is high and attention to continuing care is critical. New continuing care strategies targeting life-style change and improved coping mechanisms are important in facilitating maintenance of abstinence, promoting rehabilitation and functional recovery for Veterans with SUDs. Mindfulness-based relapse prevention (MBRP), a manualized treatment integrating cognitive-behavioral relapse prevention therapy with mindfulness practices, has shown promise in continuing care for SUDs. The proposed project will compare MBRP to a 12-Step Facilitation treatment as a continuing care strategy following primary treatment for SUDs. Participants will be randomized to participate in 8-weeks of weekly 90-minute, group-based MBRP or 12-Step Facilitation followed by a 10-month follow-up period with regular assessments of substance use, mood/anxiety symptoms, quality of life and functional outcomes. Two VAMC sites (Charleston and Tuscaloosa) with a history of successful collaboration will work together to recruit an adequate sample size to address the primary study questions within a 4-year period and to ensure generalizability of the results. If this trial demonstrates that MBRP promotes sustained abstinence and improved functional outcomes, this will provide a valuable treatment to facilitate rehabilitation and recovery for Veterans with SUDs.

Enrollment: 204 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women military Veterans who have completed the Charleston or Tuscaloosa Veterans Administration Medical Center (VAMC) intensive outpatient substance abuse treatment program, a residential treatment program, or an intensive outpatient program similar to the Charleston or Tuscaloosa VAMC program.
2. Able to comprehend English.
3. Meets DSM-V criteria for a current substance use disorder and have used substances in the 30 days prior to treatment entry. Participants on medications targeting their substance use must be stabilized on medications for at least 2 weeks before therapy initiation.
4. May meet criteria for a mood, anxiety or other psychiatric disorder. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation.
5. Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
6. Willing to commit to 8 group therapy sessions, baseline, weekly and follow-up assessments for 10-months after the end of treatment (12-month total).

Exclusion criteria

1. Active suicidal or homicidal ideation with a plan as this is likely to require hospitalization or other interventions that could interfere with study participation.
2. Unstable psychiatric condition likely to require hospitalization or other interventions that would interfere with study participation.
3. Unstable medical condition or one that may require hospitalization during the course of the study.
4. Meets criteria for nicotine dependence only
5. Women who are pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Mindfulness Based Relapse Prevention (MBRP):

Experimental group

Description:

The Introductory session provides an orientation to the intervention, basic mindfulness techniques and general description of group sessions. Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan). The therapist reviews homework assignments, discusses challenges and participants are taught a variety of mindfulness meditation (MM) practices such as breath meditation, urge surfing, walking or movement meditation.

Treatment:

Behavioral: Mindfulness Based Relapse Prevention (MBRP)

Twelve-Step Facilitation Intervention (TSF)

Active Comparator group

Description:

The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery. The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics. The intervention involves helping participants understand and incorporate core principles of 12-Step approaches while encouraging active participation in 12-Step meetings and related activities. The primary goal is to promote abstinence by facilitating the patient's acceptance and surrender of addiction. Sessions begin with a check-in during which participants introduce themselves, report on meeting attendance and participation in related activities, any alcohol/drug use or craving to use. The remainder of the session focuses on discussion of the topic content followed by a "take home" summary and homework assignment.

Treatment:

Behavioral: Twelve-Step Facilitation Intervention (TSF)