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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AA017508-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation | Experimental | Mindfulness Based Relapse Prevention for Alcohol Dependence intervention + Standard of Care therapy |
|
| Wait-list control | Other | Standard of Care therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention for Alcohol Dependence | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Zgierska, MD PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19904664 | Background | 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. | |
| 21768988 | Background | 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. |
| Label | URL |
|---|---|
| brief description of the findings from the pilot study | View source |
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In the initial 26 weeks [Period 1], this was a randomized controlled trial. After the 26 week assessment, control participants were eligible to receive the meditation intervention, however, some elected not to receive the intervention [non-randomized trial]; all study participants were followed up for additional 26 weeks [Period 2].
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| ID | Title | Description |
|---|---|---|
| FG000 | Meditation | Mindfulness Based Relapse Prevention intervention + Standard of Care therapy Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly 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 whole study. |
| FG001 | Wait-list Control | Standard of Care therapy only "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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Controlled Trial |
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| Follow up - Non-randomized |
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| ID | Title | Description |
|---|---|---|
| BG000 | Meditation | Mindfulness Based Relapse Prevention intervention + Standard of Care therapy Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly 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 whole study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit. | Posted | Mean | Standard Deviation | percentage of heavy drinking days | 26 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meditation | Mindfulness Based Relapse Prevention intervention + Standard of Care therapy Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly 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 whole study. |
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Lack of blinding of study staff to group status (except the statistician who was blinded during initial primary analyses); conducting most study related activities by the same core group of research staff may have introduced bias and placebo effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Zgierska, MD PhD | University of Wisconsin Madison | (608) 263-7882 | aleksandra.zgierska@fammed.wisc.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D064866 | Mindfulness |
| D019122 | Meditation |
| D055502 | Secondary Prevention |
| D059039 | Standard of Care |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
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|
|
| "Wait-list" control | 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. |
|
|
| 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 |
| 19904663 | Background | 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. |
| NOT COMPLETED |
|
|
| BG001 | Wait-list Control | Standard of Care therapy only "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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Wait-list Control | Standard of Care therapy only "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. |
|
|
| Secondary | 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). | Only 98 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit. | Posted | Mean | Standard Deviation | Scores on a scale | 26 weeks |
|
|
|
| Secondary | Subject Treatment Satisfaction | Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied'). | 48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed. | Posted | Mean | Standard Deviation | points | 8 weeks |
|
|
|
| Secondary | 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. | Of 64 enrolled participants, one withdrew prior to the first intervention session. This participant's data was included in the baseline data analyses; this participant's meditation intervention attendance was counted as "0". | Posted | Number | Percentage of meditation participants | 8 weeks |
|
|
|
| Primary | Percent Days Abstinent From Alcohol | Measures percent days abstinent from alcohol | Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit. | Posted | Mean | Standard Deviation | percent of days abstinent from alcohol | 26 weeks |
|
|
|
| Primary | Time to Relapse (Resumption of Drinking) | Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks. | Only 105 participants provided data for this measure at 26-week follow up; due to participants either: declining participation for the visit, being unable to reach within the 26-week follow up time, or withdrawing from the study before 26-week follow up. Of the 105, 3 meditation/0 controls met criteria for having relapsed during this time frame. | Posted | Mean | Standard Deviation | number of days to relapse | 26 weeks |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Wait-list Control | Standard of Care therapy only "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. | 0 | 59 | 0 | 59 |
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| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |