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Substance AbuseMBR-VeteransNCT02326363

Mindfulness-Based Recovery in Veterans

A study testing Mindfulness Based Relapse Prevention (MBRP) and Twelve-Step Facilitation Intervention (TSF) in people with Substance Abuse and Depression, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Substance Abuse, Depression, Anxiety Disorder
What is being tested?
Mindfulness Based Relapse Prevention (MBRP) and Twelve-Step Facilitation Intervention (TSF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
2 sitesUnited States
Study dates
16 Mar 2015to 29 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5799

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    Tuscaloosa, Alabama, 35404

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Mindfulness Based Relapse Prevention (MBRP), Twelve-Step Facilitation Intervention (TSF)
Keywords
substance abuse, Mental Health Disorders
Medical subject headings
Substance-Related Disorders, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Relapse Prevention (MBRP)Behavioural

    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.

  • Twelve-Step Facilitation Intervention (TSF)Behavioural

    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.

Study groups in NCT02326363
Study groupRoleWhat they receive
Mindfulness Based Relapse Prevention (MBRP):ExperimentalThe 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.
Receives: Behavioral: Mindfulness Based Relapse Prevention (MBRP)
Twelve-Step Facilitation Intervention (TSF)Active comparatorThe 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.
Receives: Behavioral: Twelve-Step Facilitation Intervention (TSF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Study Treatment Duration up to 8 Weeks

  2. 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.

    Measured: Study Treatment Duration through 10 Months Follow up

  3. 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.

    Measured: Study Treatment Duration through 10 Months

Secondary outcomes (10)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: Week 8, 3 Months, 6 Months, 10 Months

  6. 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).

    Measured: 8 Weeks, 3 Months, 6 Months, 10 Months

  7. 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.

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

  8. 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.

    Measured: Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months

  9. 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.

    Measured: Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months

  10. 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.

    Measured: End of Study (up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2014 (estimated)
  2. Study start16 Mar 2015
  3. Primary completion29 Oct 2018
  4. Study completion29 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326363
Sponsor's protocol ID
D1292-R
Other IDs
I01RX001292
Acronym
MBR-Veterans
Status last verified
Jan 2021
First submitted
22 Dec 2014
Last updated
10 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37364669

  • 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.

    PubMed 33857680

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Relapse Prevention (MBRP) and Twelve-Step Facilitation Intervention (TSF) in people with Substance Abuse and Depression, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date (time frame: Study Treatment Duration up to 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02326363, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.

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