University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
NCT Number: NCT01056484
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Madison, Wisconsin, 53705, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
'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
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.
Time frame: 26 weeks
Measures percent days abstinent from alcohol
Time frame: 26 weeks
Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
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).
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').
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.
University of Wisconsin, Madison
Other
Mindfulness Meditation For Alcohol Relapse Prevention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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