Mindfulness-Based Recovery in Veterans (MBR-Veterans)

Mindfulness-Based Recovery in Veterans With Substance Use Disorders

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.

Study Overview

• Status: Completed
• Conditions: Depression; Substance Abuse; Anxiety Disorder
• Intervention / Treatment: Behavioral: Mindfulness Based Relapse Prevention (MBRP); Behavioral: Twelve-Step Facilitation Intervention (TSF)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35404
      • Tuscaloosa VA Medical Center, Tuscaloosa, AL
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5799
      • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Relapse Prevention (MBRP): 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); 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.
Active Comparator: Twelve-Step Facilitation Intervention (TSF); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness Acceptance and Awareness Scale (MAAS)	This is a 15-item self-report instrument rating the frequency of experiencing impaired moment-to-moment attention on a 6-point Likert scale. Scores range from 1- 6 with higher scores indicating higher levels of mindfulness. This measure explores the relationship between MAAS scores and treatment response.	Baseline, End of treatment, 3 Months, 6 Months, 10 Months
Beck Depression Inventory 2	This 21-item self-report scale will be used to assess for worsening depression/suicidality in safety monitoring. Scores range from 0 - 63 with higher scores indicating more severe depression.	Baseline, End of Treatment, 3 Months, 6 Months, 10 Months
Beck Anxiety Inventory	This 21-item self-report scale has symptom clusters reflecting neurophysiological, subjective, panic, and autonomic dimensions. Scores range from 0-63 with higher scores indicating more severe anxiety.	Baseline, End of Treatment, 3 Months, 6 Months, 10 Months
Urine Drug Screen	Observed urine samples will be collected with a RapidCHECK Multi-Drug 10 Panel Test, which allows detection of tetrahydrocannabinol (THC)/marijuana, cocaine, phencyclidine, opiates, methamphetamines, methadone, amphetamines, barbiturates, benzodiazepines and uses concentrations levels established by the National Institute on Drug Abuse (NIDA) and the World Health Organization (WHO). Osmolality and temperature assessed at collection time to insure sample validity.	Weekly, Week 8, 3 Months, 6 Months, 10 Months
EtG	The conjugated alcohol metabolite ethyl glucuronide (EtG) remains positive in urine for several days following cessation and is a useful biomarker of recent drinking in outpatient settings (Dahl 2011). This will be used as the primary biologic assessment of drinking status as breathalyzer tests only assess very recent alcohol use. The assay will be done in the Charleston VAMC laboratory on samples collected at baseline, end of treatment and 3-, 6-, and 10-month follow-up visits.	Week 8, 3 Months, 6 Months, 10 Months
Addiction Severity Index, Lite	This standardized, multidimensional, semi-structured interview provides information concerning functioning in six domains commonly impacted by substance abuse: alcohol/drug, medical, psychiatric, legal, family/social and employment. The alcohol/drug scale composite score will be reported to determine severity of alcohol/drug problem severity. The average range is 0 (denoting a better outcome) to 1 ( denoting a worse outcome).	8 Weeks, 3 Months, 6 Months, 10 Months
Days Engaging in Structured/Productive Work Activities (PWAC)	The PWAC will be used to assess self-reported days engaged in structured, volunteer, or employed work activity of at least 1 hour in duration. VISTA queries using Compensated Work Therapy and Veterans Enrichment Program stop codes will be run for medical record corroboration. Activities outside of the VA will be included.	Weekly, Week 8, 3 Months, 6 Months, 10 Months
Treatment Engagement: Treatment Attendance Calendar (TAC)	The TAC will be used to assess the total number of days treated for a substance abuse/mental health problem in the VA or other outpatient setting, 12-step or self-help group meetings, physician contacts and,hospitalization by treatment group. The TAC measure represent the total number of days experiencing any of these events by treatment group.	Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.	This 16-item scale, used to assess satisfaction with major areas of life function, has convergent and discriminant construct validity in chronic illness as evidenced by high correlations between the QOLS total score and Life Satisfaction Index. Scores range from 1 = 112 with higher scores indicating higher satisfaction with quality of life.	Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months
Urine Drug Screen - End of Study	Observed urine samples will be collected with a RapidCHECK Multi-Drug 10 Panel Test, which allows detection of tetrahydrocannabinol (THC)/marijuana, cocaine, phencyclidine, opiates, methamphetamines, methadone, amphetamines, barbiturates, benzodiazepines and uses concentrations levels established by the National Institute on Drug Abuse (NIDA) and the World Health Organization (WHO). Osmolality and temperature assessed at collection time to insure sample validity.	End of Study (up to 1 year)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MINI-International Neuropsychiatric Interview	The MINI is a well-standardized structured interview which is similar in sensitivity, specificity, and inter-rater reliability to other more lengthy diagnostic interviews, such as the Structured Clinical Interview for DSM-IV. A DSM-V version of the MINI is not available, so DSM-IV criteria will be utilized. The MINI will be used at baseline to assess psychiatric diagnoses for inclusion/exclusion and urn randomization purposes.	Baseline
Montreal Cognitive Assessment (MOCA)	This brief, well-validated instrument will be used at baseline to screen for cognitive impairment that could interfere with ability to benefit from MBRP. A cut-off of 26/30 is considered normal. Scores range from 0 - 30 with lower scores indicating mores severe cognitive impairment.	Baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kathleen Theresa Brady, MD PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Actual): October 29, 2018
• Study Completion (Actual): October 29, 2018

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 29, 2014

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: substance abuse; Mental Health Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Anxiety Disorders
• Other Study ID Numbers: D1292-R; I01RX001292 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No