Mindfulness Meditation for Health

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01056484
First received: January 22, 2010
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Alcohol Dependence
Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence
Other: "Wait-list" control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation For Alcohol Relapse Prevention

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Percent Heavy Drinking Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measures percent days abstinent from alcohol

  • Time to Relapse (Resumption of Drinking) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.


Secondary Outcome Measures:
  • Drinker Inventory of Consequences [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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: 26 weeks ] [ Designated as safety issue: No ]
    Treatment adherence and satisfaction rating.

  • Subject Treatment Adherence [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: September 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056484

Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Aleksandra Zgierska, MD PhD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01056484     History of Changes
Other Study ID Numbers: H-2009-0118, 1K23AA017508-01A1
Study First Received: January 22, 2010
Results First Received: April 30, 2014
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Alcohol Dependence
Alcoholism
Substance Use Disorders
Substance Abuse

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014