Intensive Meditation and Migraines: Effects on Health and Well Being

NCT ID: NCT00663585

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Daily Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Structured Intervention Group

Group Type EXPERIMENTAL

Vipassana Meditation

Intervention Type BEHAVIORAL

12 day retreat where participants learn to meditate

2.Comparison group

Unstructured comparison group

Group Type ACTIVE_COMPARATOR

Vipassana Meditation

Intervention Type BEHAVIORAL

12 day retreat where participants learn to meditate

Interventions

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Vipassana Meditation

12 day retreat where participants learn to meditate

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Madhav Goyal

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhav Goyal, MD, MPH

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

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Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Goyal M, Haythornthwaite JA, Jain S, Peterlin BL, Mehrotra M, Levine D, Rosenberg JD, Minges M, Seminowicz DA, Ford DE. Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial. Mindfulness (N Y). 2023 Feb;14(2):406-417. doi: 10.1007/s12671-023-02073-z. Epub 2023 Jan 24.

Reference Type DERIVED
PMID: 38282695 (View on PubMed)

Other Identifiers

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RR023266

Identifier Type: -

Identifier Source: secondary_id

NA_00016428

Identifier Type: -

Identifier Source: org_study_id

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