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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. Identifier: NCT01056484
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : August 4, 2014
Last Update Posted : November 6, 2014
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this 52-week clinical trial is to see if the meditation-based intervention, adjunctive to standard of care therapy, can reduce relapse and improve psychological health among adults recovering from alcohol dependence.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence Other: "Wait-list" control Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: Meditation
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.
Other Names:
  • Mindfulness Meditation
  • Meditation
  • Mindfulness
  • Relapse Prevention

Wait-list control
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.
Other Names:
  • Standard of Care
  • Treatment as Usual

Primary Outcome Measures :
  1. 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.

  2. Percent Days Abstinent From Alcohol [ Time Frame: 26 weeks ]
    Measures percent days abstinent from alcohol

  3. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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').

  3. 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.

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Alcohol dependence diagnosis
  • Completed at least 2 weeks of IOP or (IOP equivalent=at least 2 days per week) for alcohol dependence
  • Sober since beginning of outpatient treatment
  • English fluency; ability to fill out surveys
  • Permanent home address and telephone
  • At least 18 years old
  • Score >13 on the Perceived Stress Scale

Exclusion Criteria:

  • Pregnant
  • Alcohol abstinence >14 weeks before enrollment
  • Current, regular meditation
  • Pre-existing bipolar, schizophrenia, or delusional disorder
  • Regular drug use (other than tobacco) in last 2 weeks
  • Inability to reliably participate

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 identifier (NCT number): NCT01056484

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United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Aleksandra Zgierska, MD PhD University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison Identifier: NCT01056484    
Other Study ID Numbers: H-2009-0118
1K23AA017508-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2010    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: November 6, 2014
Last Verified: October 2014
Keywords provided by University of Wisconsin, Madison:
Alcohol Dependence
Substance Use Disorders
Substance Abuse
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders