Mindfulness-Based Recovery in Veterans (MBR-Veterans)
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|ClinicalTrials.gov Identifier: NCT02326363|
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : December 13, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Beck Anxiety Inventory [ Time Frame: 1 year ]This 21-item self-report scale has symptom clusters reflecting neurophysiological, subjective, panic, and autonomic dimensions.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Kathleen Theresa Brady, MD PhD||Ralph H. Johnson VA Medical Center, Charleston, SC|