Intensive Meditation and Migraines: Effects on Health and Well Being

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00663585
First received: April 21, 2008
Last updated: February 11, 2010
Last verified: October 2008
  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 Meditation

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

Resource links provided by NLM:


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
Experimental: 1
Structured Intervention Group
Behavioral: Vipassana Meditation
12 day retreat where participants learn to meditate
Active Comparator: 2.Comparison group
Unstructured comparison group
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663585

Contacts
Contact: Madhav Goyal, MD, MPH (410) 502-8814 madhav@jhmi.edu

Locations
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Sub-Investigator: Madhav Goyal, MD, MPH         
Principal Investigator: Daniel E. Ford, MD,MPH         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Study Director: Madhav Goyal, MD, MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Madhav Goyal, Assistant Professor, Johns Hopkins School of Medicine, Dept of Medicine
ClinicalTrials.gov Identifier: NCT00663585     History of Changes
Other Study ID Numbers: NA_00016428, RR023266
Study First Received: April 21, 2008
Last Updated: February 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Migraine
Headache
Vipassana
Meditation
Intensive

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014