Mindfulness Meditation for Health
|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: NCT01056484|
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : August 4, 2014
Last Update Posted : November 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence Other: "Wait-list" control||Phase 2|
The goal of this partially-blinded, two-arm clinical trial was to test whether the Mindfulness Meditation Relapse Prevention (meditation), combined with 'standard of care' (SOC) therapy, is more effective in preventing a return to drinking than SOC alone (wait-list control) among adult recovering alcoholics. The intervention was manualized and based on existing models. It was proposed that meditation may improve outcomes of interest through reduction of the severity of stress-related relapse risk factors such as perceived stress, anxiety, depression, craving and emotion dysregulation, and the level of stress-sensitive biomarkers (cytokine interleukin-6, liver enzymes).
For this study, 123 adult alcohol dependent subjects were recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 26-weeks (Period 1, Randomized Controlled Trial, RCT). The RCT evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject treatment satisfaction and adherence as secondary outcomes. It also gathered preliminary data on potential mechanisms of meditation action. After the completion of their 26-week RCT (Period 1), controls were eligible to receive the meditation intervention ("cross-over"), and all participants were followed-up for additional 26 weeks (non-randomized Period 2).
This study will provide evidence about the efficacy of meditation for alcohol relapse prevention, will further our understanding of relapse and the potential mechanisms of meditation action, direct future research and guide clinical decision-making.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mindfulness Meditation For Alcohol Relapse Prevention|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Mindfulness Based Relapse Prevention for Alcohol Dependence intervention + Standard of Care therapy
Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence
All subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. Experimental subjects also receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. The intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and "traditional" cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the study.
Standard of Care therapy only
Other: "Wait-list" control
'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC.
- Percent Heavy Drinking Days [ Time Frame: 26 weeks ]Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.
- Percent Days Abstinent From Alcohol [ Time Frame: 26 weeks ]Measures percent days abstinent from alcohol
- Time to Relapse (Resumption of Drinking) [ Time Frame: 26 weeks ]Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
- Drinker Inventory of Consequences [ Time Frame: 26 weeks ]Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time).
- Subject Treatment Satisfaction [ Time Frame: 8 weeks ]Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').
- Subject Treatment Adherence [ Time Frame: 8 weeks ]Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.
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): NCT01056484
|United States, Wisconsin|
|University of Wisconsin-Madison|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Aleksandra Zgierska, MD PhD||University of Wisconsin, Madison|