Chronic Daily HeadacheNCT00663585
Intensive Meditation and Migraines: Effects on Health and Well Being
A study testing Vipassana Meditation in people with Chronic Daily Headache, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Daily Headache
- What is being tested?
- Vipassana Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
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.
- Conditions
- Chronic Daily Headache
- Being tested
- Vipassana Meditation
- Keywords
- Migraine, Headache, Vipassana, Meditation, Intensive
- Medical subject headings
- Headache Disorders, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vipassana MeditationBehavioural
12 day retreat where participants learn to meditate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Structured Intervention Group Receives: Behavioral: Vipassana Meditation |
| 2.Comparison group | Active comparator | Unstructured comparison group Receives: Behavioral: Vipassana Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of migraine days, number of headache days
Measured: 3,6,12 months
Secondary outcomes (3)
severity of headaches
Measured: 3,6,12 months
quality of life
Measured: 3,6,12 months
Heart Rate Variability
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Daily HeadacheStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhav Goyal, Johns Hopkins University
- Investigators
- Madhav Goyal, MD, MPH, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663585
- Sponsor's protocol ID
- NA_00016428
- Other IDs
- RR023266
- Status last verified
- Jul 2016
- First submitted
- 21 Apr 2008
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38282695
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Meditation and Migraines: Effects on Health and Well Being
- ClinicalTrials.gov ID
- NCT00663585
- Acronym / sponsor ID
- NA_00016428
- Conditions
- Chronic Daily Headache
- Keywords
- Migraine, Headache, Vipassana, Meditation, Intensive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Vipassana MeditationStructured Intervention Group |
| 2.Comparison group | Active comparator | Behavioral: Vipassana MeditationUnstructured comparison group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vipassana Meditation12 day retreat where participants learn to meditate | Behavioural | 1, 2.Comparison group |
Primary outcome
number of migraine days, number of headache days
Time frame: 3,6,12 months
3 secondary outcomes
severity of headaches
Time frame: 3,6,12 months
quality of life
Time frame: 3,6,12 months
Heart Rate Variability
Time frame: 3,6,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 38282695Goyal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhav Goyal, MD, MPH study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vipassana Meditation in people with Chronic Daily Headache, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of migraine days, number of headache days (time frame: 3,6,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.