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MigraineNCT02133209

MRI Outcomes of Mindfulness Meditation for Migraine

A study testing Mindfulness Based Stress Reduction and Stress Management for Headaches in people with Migraine, run by Johns Hopkins University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including headache frequency and impact and brain activity, will be assessed at baseline, prior to intervention, and at 3-, 6-, and 12-months. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Migraine
What is being tested?
Mindfulness Based Stress Reduction and Stress Management for Headaches
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
2 sitesUnited States
Study dates
May 2014to Mar 2018
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are between 18 and 65 years of age
  • Report between 4 and 14 headaches over 28 days
  • Have a history of migraines lasting at least 1 year
  • Are not currently using opioid ("narcotic") pain medication

Who cannot join

  • Are unable to undergo MRI
  • Pregnant, lactating, or planning to become pregnant
  • Current use of opioid medications
  • Inclusion Criteria for Healthy Volunteers (same exclusion criteria)
  • Are between 18 and 65 years of age
  • Free of any acute or chronic pain condition and reports no history of migraines

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Maryland School of Dentistry

    Baltimore, Maryland, 21201

  • Johns Hopkins University, Bayview Medical Campus

    Baltimore, Maryland, 21224

Other trials in United States

About this study

112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including headache frequency and impact and brain activity, will be assessed at baseline, prior to intervention, and at 3-, 6-, and 12-months.

Read the detailed description

Subjects in the MBSR group undergo a standardized 8-week MBSR course plus an additional 4 sessions over another 8 weeks that further emphasize and train subjects on MBSR concepts and skills. The SMH group will have 12 sessions spread out in a similar fashion to MBSR. Clinical outcomes are compared between groups at 3, 6, and 12 months to assess efficacy of MBSR. MRI scans are performed at baseline, 3 months, and 6 months changes in MRI metrics after MBSR and changes in MRI metrics associated with long-term MBSR practice. 30 healthy controls will also undergo MRI scanning to determine abnormal brain activity and structure in migraineurs compared to healthy controls across the 6 month period of observation.

Conditions
Migraine
Being tested
Mindfulness Based Stress Reduction, Stress Management for Headaches
Keywords
migraine, headache, meditation, mindfulness based stress reduction, MBSR
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Stress ReductionBehavioural

    Mindfulness Based Stress Reduction (MBSR) involves focused attention while practicing moment-to-moment nonjudgmental awareness of the self with the goal of achieving emotional balance and clarity of thought. There will be 8 weekly sessions and a half day retreat followed by 4 bi-weekly sessions over a period of 4 months.

  • Stress Management for HeadachesBehavioural

    Intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills, headache symptoms and their management, sleep hygiene, and healthy eating. There will be 8 weekly sessions followed by 4 bi-weekly sessions over a period of 4 months.

Study groups in NCT02133209
Study groupRoleWhat they receive
Stress Management for HeadachesActive comparatorThis intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills for managing migraine headaches.
Receives: Behavioral: Stress Management for Headaches
Mindfulness Based Stress ReductionActive comparatorIntervention involves a standardized mindfulness-based stress reduction (MBSR) group intervention following the guidelines originally conceived and developed by the Center for Mindfulness in Medicine, Health Care and Society at the University of Massachusetts. The intervention also included an extended period of training in addition to the usual 8 weeks.
Receives: Behavioral: Mindfulness Based Stress Reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in headache frequency and impact

    Headache days per 28 days and headache-related disability (HIT-6)

    Measured: Baseline, 3, 6, and 12 months

  2. Change in gray matter volume

    Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate

    Measured: Baseline, 3, and 6 months

  3. Change in Brain Function

    Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula

    Measured: Baseline, 3, and 6 months

Secondary outcomes (3)

  1. Change in headache intensity

    Change in headache intensity

    Measured: Baseline, 3, 6, and 12 months

  2. Change in Brain Structure

    Gray matter volume and white matter tracts across the whole brain

    Measured: Baseline, 3, and 6 months

  3. Change in Whole Brain Function

    Cognitive-related activity, pain-related activity, and resting state across the whole brain

    Measured: Baseline, 3, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133209
Sponsor's protocol ID
NA_00091884
Other IDs
R01AT007176
Status last verified
Aug 2018
First submitted
21 Apr 2014
Last updated
8 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Burrowes SAB, Goloubeva O, Keaser ML, Haythornthwaite JA, Seminowicz DA. Differences in gray matter volume in episodic migraine patients with and without prior diagnosis or clinical care: a cross-sectional study. J Headache Pain. 2021 Oct 23;22(1):127. doi: 10.1186/s10194-021-01340-5.

    PubMed 34688253

  • Burrowes SAB, Goloubeva O, Stafford K, McArdle PF, Goyal M, Peterlin BL, Haythornthwaite JA, Seminowicz DA. Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. Pain. 2022 Mar 1;163(3):436-444. doi: 10.1097/j.pain.0000000000002372.

    PubMed 34407032

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Stress Reduction and Stress Management for Headaches in people with Migraine, run by Johns Hopkins University at 2 sites 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 4 inclusion and 6 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change in headache frequency and impact (time frame: Baseline, 3, 6, and 12 months). The study lists 3 primary outcomes in all. 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 NCT02133209, which also lists 2 linked publications.

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 8 Aug 2018.

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