Back to resultsIntensive Meditation and Migraines: Effects on Health and Well Being
Primary Purpose
Chronic Daily Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vipassana Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Daily Headache focused on measuring Migraine, Headache, Vipassana, Meditation, Intensive
Eligibility Criteria
Inclusion Criteria:
- Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.
Exclusion Criteria:1.
- Severe depression, anxiety, panic attacks, psychosis or dementia that may interfere with ability to participate in a 10 day course
- Active alcoholism on screening or use of illicit drugs within the last 3 months
- Already completed a 10 day course
- Actively involved in another form of meditation over the past 6 months
- Women who are pregnant, planning pregnancy during trial period, or lactating.
Sites / Locations
- Johns Hopkins School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2.Comparison group
Arm Description
Structured Intervention Group
Unstructured comparison group
Outcomes
Primary Outcome Measures
number of migraine days, number of headache days
Secondary Outcome Measures
severity of headaches
quality of life
Heart Rate Variability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663585
Brief Title
Intensive Meditation and Migraines: Effects on Health and Well Being
Official Title
Intensive Meditation and Migraines: Effects on Health and Well Being
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Participants completing training in intensive meditation and continuing frequent practice for one year would experience reduced frequency, duration and severity of headaches along with improved awareness of the triggers of their symptoms, improved quality of life and mental health, improved heart rate variability, and reduced inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Daily Headache
Keywords
Migraine, Headache, Vipassana, Meditation, Intensive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Structured Intervention Group
Arm Title
2.Comparison group
Arm Type
Active Comparator
Arm Description
Unstructured comparison group
Intervention Type
Behavioral
Intervention Name(s)
Vipassana Meditation
Intervention Description
12 day retreat where participants learn to meditate
Primary Outcome Measure Information:
Title
number of migraine days, number of headache days
Time Frame
3,6,12 months
Secondary Outcome Measure Information:
Title
severity of headaches
Time Frame
3,6,12 months
Title
quality of life
Time Frame
3,6,12 months
Title
Heart Rate Variability
Time Frame
3,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.
Exclusion Criteria:1.
Severe depression, anxiety, panic attacks, psychosis or dementia that may interfere with ability to participate in a 10 day course
Active alcoholism on screening or use of illicit drugs within the last 3 months
Already completed a 10 day course
Actively involved in another form of meditation over the past 6 months
Women who are pregnant, planning pregnancy during trial period, or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhav Goyal, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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Intensive Meditation and Migraines: Effects on Health and Well Being
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