Intensive Meditation and Migraines: Effects on Health and Well Being

This study is currently recruiting participants.
Verified by Johns Hopkins University, October 2008
First Received: April 21, 2008 Last Updated: February 11, 2010

Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00663585

Purpose
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.

Condition Intervention
Chronic Daily Headache Behavioral: Vipassana Meditatio

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Meditation and Migraines: Effects on Health and Well Being

Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:

  • number of migraine days, number of headache days [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • severity of headaches [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • Heart Rate Variability [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Structured Intervention Group Intervention: Behavioral: Vipassana Meditation
Behavioral: Vipassana Meditation
12 day retreat where participants learn to meditate
2.Comparison group: Active Comparator
Unstructured comparison group Intervention: Behavioral: Vipassana Meditation
Behavioral: Vipassana Meditation
12 day retreat where participants learn to meditate

Eligibility
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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.
SHOW MAIN MENU
SHOW SUB MENU