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Trial record 21 of 5450 for:    veterans

Mindfulness-Based Recovery in Veterans (MBR-Veterans)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02326363
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Depression Anxiety Disorder Behavioral: Mindfulness Based Relapse Prevention (MBRP) Behavioral: Twelve-Step Facilitation Intervention (TSF) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Mindfulness-Based Recovery in Veterans With Substance Use Disorders
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 (Brown et al., 2002). 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.




Primary Outcome Measures :
  1. Timeline Follow-Back (TLFB) [ Time Frame: 1 year ]
    The TLFB will be used to obtain retrospective self-report of alcohol, nicotine, illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids), and prescription drug 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. At baseline, drug/alcohol use in the month before enrollment in treatment will be assessed.


Secondary Outcome Measures :
  1. Urine Drug Screen [ Time Frame: 1 year ]
    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.

  2. Alcohol Breathalyzer Test [ Time Frame: 1 year ]
    Breathalyzer tests will be used to measure subjects' blood alcohol concentration (BAC) before treatment sessions. Individuals who test positive will not attend group sessions. Samples >0.01 g/dl will be considered positive.

  3. EtG [ Time Frame: 1 year ]
    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.

  4. Mindfulness Acceptance and Awareness Scale (MAAS) [ Time Frame: 1 year ]
    This is a 15-item self-report instrument rating the frequency of experiencing impaired moment-to-moment attention on a 6-point Likert scale. This measure will be done at baseline and end of treatment and used to explore the relationship between MAAS scores and treatment response.

  5. Beck Depression Inventory 2 [ Time Frame: 1 year ]
    This 21-item self-report scale will be used to assess for worsening depression/suicidality in safety monitoring.

  6. Beck Anxiety Inventory [ Time Frame: 1 year ]
    This 21-item self-report scale has symptom clusters reflecting neurophysiological, subjective, panic, and autonomic dimensions.

  7. Addiction Severity Index, Lite [ Time Frame: 1 year ]
    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.

  8. Days Engaging in Structured/Productive Work Activities (PWAC) [ Time Frame: 1 year ]
    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.

  9. Treatment Engagement: Treatment Attendance Calendar (TAC) [ Time Frame: 1 year ]
    The TAC will be used to assess number of days treated for a substance abuse/mental health problem in the VA or any other outpatient aftercare setting, number of 12-step or self-help group meetings attended and physician contact and/or hospitalization.

  10. Quality of Life Scale (QOLS) [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Montreal Cognitive Assessment (MOCA) [ Time Frame: Baseline ]
    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.

  2. MINI-International Neuropsychiatric Interview [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326363


Locations
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United States, Alabama
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Kathleen Theresa Brady, MD PhD Ralph H. Johnson VA Medical Center, Charleston, SC

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02326363     History of Changes
Other Study ID Numbers: D1292-R
I01RX001292 ( U.S. NIH Grant/Contract )
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
substance abuse
Mental Health Disorders

Additional relevant MeSH terms:
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Anxiety Disorders
Substance-Related Disorders
Mental Disorders
Chemically-Induced Disorders