Mindfulness Meditation for Health

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Alcohol Dependence

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01056484

H-2009-0118

1K23AA017508-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

Meditation

Experimental group

Description:

Mindfulness Based Relapse Prevention for Alcohol Dependence intervention + Standard of Care therapy

Treatment:

Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence

Wait-list control

Other group

Description:

Standard of Care therapy only

Treatment:

Other: "Wait-list" control