Mindfulness Meditation for Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mindfulness Meditation For Alcohol Relapse Prevention

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence
* Other: Wait-list control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation<br>Mindfulness Based Relapse Prevention for Alcohol Dependence intervention + Standard of Care therapy | Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence<br>* 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.<br>* Other names: Relapse Prevention;|
| Other: Wait-list control<br>Standard of Care therapy only | Other: Wait-list control<br>* '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.<br>* Other names: Treatment as Usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinker Inventory of Consequences | 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). | 26 weeks | 
| Subject Treatment Satisfaction | Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied'). | 8 weeks | 
| Subject Treatment Adherence | Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Alcoholism, Substance Use Disorders, Substance Abuse