Mindfulness Meditation for Health

NCT ID: NCT01056484

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-05-31

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Meditation

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

Group Type: EXPERIMENTAL

Mindfulness Based Relapse Prevention for Alcohol Dependence

Intervention Type: BEHAVIORAL

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.

Wait-list control

Standard of Care therapy only

Group Type: OTHER

"Wait-list" control

Intervention Type: OTHER

'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.

Interventions

Mindfulness Based Relapse Prevention for Alcohol Dependence

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.

Intervention Type: BEHAVIORAL

"Wait-list" control

'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.

Intervention Type: OTHER

Other Intervention Names

Mindfulness Meditation; Meditation; Mindfulness; Relapse Prevention; Standard of Care; Treatment as Usual

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandra Zgierska, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19904664 (View on PubMed)

Zgierska 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.

Reference Type: BACKGROUND

PMID: 21768988 (View on PubMed)

Marcus 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.

Reference Type: BACKGROUND

PMID: 19904663 (View on PubMed)

Related Links

http://www.fammed.wisc.edu/research/external-funded/alcohol-prevention

brief description of the findings from the pilot study

Other Identifiers

1K23AA017508-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-2009-0118

Identifier Type: -

Identifier Source: org_study_id