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: October 15, 2008 History of Changes

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 Meditation

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Intensive Meditation and Migraines: Effects on Health and Well Being

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

# of migraine days, # 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 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

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

More Information

No publications provided

Responsible Party:	Johns Hopkins School of Medicine, Dept of Medicine ( Madhav Goyal, Postdoctoral Fellow )
Study ID Numbers:	NA_00016428, RR023266
Study First Received:	April 21, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00663585 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Migraine
Headache
Vipassana
Meditation
Intensive

Additional relevant MeSH terms:

Signs and Symptoms
Migraine Disorders
Nervous System Diseases
Headache
Central Nervous System Diseases

Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on November 20, 2009