Mindfulness Meditation for Health
Mindfulness Meditation For Alcohol Relapse Prevention
2 other identifiers
interventional
123
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedNovember 6, 2014
October 1, 2014
3.7 years
January 22, 2010
April 30, 2014
October 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percent Heavy Drinking Days
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.
26 weeks
Percent Days Abstinent From Alcohol
Measures percent days abstinent from alcohol
26 weeks
Time to Relapse (Resumption of Drinking)
Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
26 weeks
Secondary Outcomes (3)
Drinker Inventory of Consequences
26 weeks
Subject Treatment Satisfaction
8 weeks
Subject Treatment Adherence
8 weeks
Study Arms (2)
Meditation
EXPERIMENTALMindfulness Based Relapse Prevention for Alcohol Dependence intervention + Standard of Care therapy
Wait-list control
OTHERStandard of Care therapy only
Interventions
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' (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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Related Publications (3)
Zgierska A, Rabago D, Chawla N, Kushner K, Koehler R, Marlatt A. Mindfulness meditation for substance use disorders: a systematic review. Subst Abus. 2009 Oct-Dec;30(4):266-94. doi: 10.1080/08897070903250019.
PMID: 19904664BACKGROUNDZgierska A, Rabago D, Zuelsdorff M, Coe C, Miller M, Fleming M. Mindfulness meditation for alcohol relapse prevention: a feasibility pilot study. J Addict Med. 2008 Sep;2(3):165-73. doi: 10.1097/ADM.0b013e31816f8546.
PMID: 21768988BACKGROUNDMarcus MT, Zgierska A. Mindfulness-based therapies for substance use disorders: part 1. Subst Abus. 2009 Oct-Dec;30(4):263-5. doi: 10.1080/08897070903250027. No abstract available.
PMID: 19904663BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Lack of blinding of study staff to group status (except the statistician who was blinded during initial primary analyses); conducting most study related activities by the same core group of research staff may have introduced bias and placebo effect.
Results Point of Contact
- Title
- Aleksandra Zgierska, MD PhD
- Organization
- University of Wisconsin Madison
Study Officials
- PRINCIPAL INVESTIGATOR
Aleksandra Zgierska, MD PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 26, 2010
Study Start
September 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 6, 2014
Results First Posted
August 4, 2014
Record last verified: 2014-10