Mindfulness-Based Recovery in Veterans

NCT02326363 | Completed Results DMC

• 2 other identifiers: D1292-RI01RX001292
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Substance Abuse; Depression; Anxiety Disorder

Keywords

substance abuse; Mental Health Disorders

Outcome Measures

Primary Outcomes (3)

• Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date

  The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use in treatment up to 8 weeks will be assessed.

  Study Treatment Duration up to 8 Weeks

• Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date

  The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports (Carey, 1997). Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use during treatment through10 months will be assessed.

  Study Treatment Duration through 10 Months Follow up

• Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data

  The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Participants that failed to return for any treatment or follow up visits are considered censored at study day 1.

  Study Treatment Duration through 10 Months

Secondary Outcomes (10)

• Mindfulness Acceptance and Awareness Scale (MAAS)

  Baseline, End of treatment, 3 Months, 6 Months, 10 Months

• Beck Depression Inventory 2

  Baseline, End of Treatment, 3 Months, 6 Months, 10 Months

• Beck Anxiety Inventory

  Baseline, End of Treatment, 3 Months, 6 Months, 10 Months

• Urine Drug Screen

  Weekly, Week 8, 3 Months, 6 Months, 10 Months

• EtG

  Week 8, 3 Months, 6 Months, 10 Months

Other Outcomes (2)

• MINI-International Neuropsychiatric Interview

  Baseline

• Montreal Cognitive Assessment (MOCA)

  Baseline

Study Arms (2)

Mindfulness Based Relapse Prevention (MBRP):

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Relapse Prevention (MBRP)

Twelve-Step Facilitation Intervention (TSF)

ACTIVE COMPARATOR

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.

Behavioral: Twelve-Step Facilitation Intervention (TSF)

Interventions

Mindfulness Based Relapse Prevention (MBRP) BEHAVIORAL

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 MM practices such as breath meditation, urge surfing, walking or movement meditation.

Mindfulness Based Relapse Prevention (MBRP):

Twelve-Step Facilitation Intervention (TSF) BEHAVIORAL

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.

Twelve-Step Facilitation Intervention (TSF)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to comprehend English.
• 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.
• 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.
• Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (2)

• Killeen TK, Baker NL, Davis LL, Bowen S, Brady KT. Efficacy of mindfulness-based relapse prevention in a sample of veterans in a substance use disorder aftercare program: A randomized controlled trial. J Subst Use Addict Treat. 2023 Sep;152:209116. doi: 10.1016/j.josat.2023.209116. Epub 2023 Jun 25.

  PMID: 37364669 DERIVED

• Brady KT, Killeen T, Baker NL. Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106393. doi: 10.1016/j.cct.2021.106393. Epub 2021 Apr 20.

  PMID: 33857680 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Nathaniel L Baker
• Organization: Medical University of South Carolina

bakern@musc.edu

843-792-5028

Study Officials

• Kathleen Theresa Brady, MD PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 29, 2014
• Study Start: March 16, 2015
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: February 10, 2021
• Results First Posted: July 10, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)