Mindfulness Meditation for Health

Phase 2

Completed

Conditions: Alcohol Dependence

Interventions: Other: "Wait-list" control
Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence

Registration Number: NCT01056484

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 123

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait-list control	"Wait-list" control	Standard of Care therapy only
Meditation	Mindfulness Based Relapse Prevention for Alcohol Dependence	Mindfulness Based Relapse Prevention for Alcohol Dependence intervention + Standard of Care therapy

Primary Outcome Measures

Name	Time	Method
Time to Relapse (Resumption of Drinking)	26 weeks	Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
Percent Heavy Drinking Days	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.
Percent Days Abstinent From Alcohol	26 weeks	Measures percent days abstinent from alcohol

Secondary Outcome Measures

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