Clinical trial NCT02326363: Mindfulness-Based Recovery in Veterans
Official title: Mindfulness-Based Recovery in Veterans With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Depression
Anxiety Disorder
Keywords: substance abuse
Mental Health Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-12-29
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date
timeFrame: Study Treatment Duration up to 8 Weeks
measure: Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date
timeFrame: Study Treatment Duration through 10 Months Follow up
measure: Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data
timeFrame: Study Treatment Duration through 10 Months
Secondary outcomes:
measure: Mindfulness Acceptance and Awareness Scale (MAAS)
timeFrame: Baseline, End of treatment, 3 Months, 6 Months, 10 Months
measure: Beck Depression Inventory 2
timeFrame: Baseline, End of Treatment, 3 Months, 6 Months, 10 Months
measure: Beck Anxiety Inventory
timeFrame: Baseline, End of Treatment, 3 Months, 6 Months, 10 Months
measure: Urine Drug Screen
timeFrame: Weekly, Week 8, 3 Months, 6 Months, 10 Months
measure: EtG
timeFrame: Week 8, 3 Months, 6 Months, 10 Months
measure: Addiction Severity Index, Lite
timeFrame: 8 Weeks, 3 Months, 6 Months, 10 Months
measure: Days Engaging in Structured/Productive Work Activities (PWAC)
timeFrame: Weekly, Week 8, 3 Months, 6 Months, 10 Months
measure: Treatment Engagement: Treatment Attendance Calendar (TAC)
timeFrame: Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months
measure: Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
timeFrame: Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months
measure: Urine Drug Screen - End of Study
timeFrame: End of Study (up to 1 year)
Other outcomes:
measure: MINI-International Neuropsychiatric Interview
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Kathleen Theresa Brady, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.