NCT00663585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

5.8 years

First QC Date

April 21, 2008

Last Update Submit

July 28, 2016

Conditions

Keywords

MigraineHeadacheVipassanaMeditationIntensive

Outcome Measures

Primary Outcomes (1)

  • number of migraine days, number of headache days

    3,6,12 months

Secondary Outcomes (3)

  • severity of headaches

    3,6,12 months

  • quality of life

    3,6,12 months

  • Heart Rate Variability

    3,6,12 months

Study Arms (2)

1

EXPERIMENTAL

Structured Intervention Group

Behavioral: Vipassana Meditation

2.Comparison group

ACTIVE COMPARATOR

Unstructured comparison group

Behavioral: Vipassana Meditation

Interventions

12 day retreat where participants learn to meditate

12.Comparison group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Headache DisordersMigraine DisordersHeadache

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Madhav Goyal, MD, MPH

    Johns Hopkins University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 22, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations