Intensive Meditation and Migraines: Effects on Health and Well Being

This study is currently recruiting participants.

Verified October 2008 by Johns Hopkins University

First Received on April 21, 2008. Last Updated on February 11, 2010 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:	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:

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:

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

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
Migraine Disorders
Headache Disorders
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012