Trial Outcomes & Findings for Mindfulness Meditation for Health (NCT NCT01056484)
NCT ID: NCT01056484
Last Updated: 2014-11-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
26 weeks
Results posted on
2014-11-06
Participant Flow
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 \[Period 2\].
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Randomized Controlled Trial
STARTED
|
64
|
59
|
|
Randomized Controlled Trial
COMPLETED
|
57
|
58
|
|
Randomized Controlled Trial
NOT COMPLETED
|
7
|
1
|
|
Follow up - Non-randomized
STARTED
|
57
|
58
|
|
Follow up - Non-randomized
COMPLETED
|
57
|
56
|
|
Follow up - Non-randomized
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Randomized Controlled Trial
Withdrawal by Subject
|
6
|
1
|
|
Randomized Controlled Trial
Physician Decision
|
1
|
0
|
|
Follow up - Non-randomized
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Mindfulness Meditation for Health
Baseline characteristics by cohort
| Measure |
Meditation
n=64 Participants
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.
|
Wait-list Control
n=59 Participants
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.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
59 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Meditation
n=52 Participants
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.
|
Wait-list Control
n=53 Participants
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.
|
|---|---|---|
|
Percent Heavy Drinking Days
|
3.8 percentage of heavy drinking days
Standard Deviation 8.4
|
3.0 percentage of heavy drinking days
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: 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.
Measures percent days abstinent from alcohol
Outcome measures
| Measure |
Meditation
n=52 Participants
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.
|
Wait-list Control
n=53 Participants
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.
|
|---|---|---|
|
Percent Days Abstinent From Alcohol
|
88.5 percent of days abstinent from alcohol
Standard Deviation 22.5
|
94.1 percent of days abstinent from alcohol
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: 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.
Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
Outcome measures
| Measure |
Meditation
n=3 Participants
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.
|
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.
|
|---|---|---|
|
Time to Relapse (Resumption of Drinking)
|
29.0 number of days to relapse
Standard Deviation 13.0
|
—
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Meditation
n=47 Participants
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.
|
Wait-list Control
n=51 Participants
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.
|
|---|---|---|
|
Drinker Inventory of Consequences
|
11.3 Scores on a scale
Standard Deviation 16.9
|
16.5 Scores on a scale
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed.
Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').
Outcome measures
| Measure |
Meditation
n=48 Participants
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.
|
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.
|
|---|---|---|
|
Subject Treatment Satisfaction
|
5.5 points
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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".
Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.
Outcome measures
| Measure |
Meditation
n=64 Participants
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.
|
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.
|
|---|---|---|
|
Subject Treatment Adherence
|
71.9 Percentage of meditation participants
|
—
|
Adverse Events
Meditation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aleksandra Zgierska, MD PhD
University of Wisconsin Madison
Phone: (608) 263-7882
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place