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MigraineNCT01545466

Non-drug Interventions for Migraines

A study testing Mindfulness Based Stress Reduction (MBSR) in people with Migraine and Headache, run by Brigham and Women's Hospital at 1 site 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

This proposal describes a randomized controlled pilot trial investigating feasibility, safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness based stress reduction (MBSR) program compared to a wait-list control group. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Migraine, Headache
What is being tested?
Mindfulness Based Stress Reduction (MBSR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Feb 2012to Oct 2012
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosis of migraine (International Classification of Headache Disorders-II);21
  • 4-14 days with migraines/month
  • ≥one year of migraines
  • ≥18 years
  • Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 30-45 min/day
  • Agreeable to participate and to be randomized to either group
  • Fluent in English (since the treatment groups will be run in English)
  • Good general health with no additional diseases expected to interfere with the study

Who cannot join

  • Current regular meditation/yoga practice
  • Any major systemic illness or unstable medical or psychiatric condition (e.g. suicide risk) requiring immediate treatment or that could lead to difficulty complying with the protocol
  • Diagnosis of medication overuse headache (International Classification of Headache Disorders-II);19
  • Current or planned pregnancy or breastfeeding
  • New prophylactic migraine medicine started within 4 weeks of the screening visit
  • Unwilling to maintain stable current doses of migraine medicines for the duration of trial
  • Failure to complete baseline diary recordings of migraine activity and medication use

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Mindfulness Based Stress Reduction for Adults With Migraines: A Pilot Study

This proposal describes a randomized controlled pilot trial investigating feasibility, safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness based stress reduction (MBSR) program compared to a wait-list control group.

Read the detailed description

Preliminary research has shown MBSR to be effective in chronic pain syndromes and other mind/body interventions have shown good promise in the treatment of headaches. A randomized controlled trial (RCT) of yoga in migraine without aura patients by John and colleagues showed that yoga resulted in a significant decrease in headache frequency, pain index, and symptomatic medication usage compared to a self-care group. This RCT demonstrated that patients with headaches may benefit from a mind-body intervention. However, their yoga protocol was not specified, and participants were instructed to practice the technique only during the prodromal phase of a headache (prior to the pain becoming severe), so as an abortive intervention at the time of a headache. Thus, the investigators of this trial are proposing to evaluate the effect of MBSR on adults with migraines compared to an education control group. This study will add to the John study because, unlike many other mind-body interventions, MBSR offers the distinct advantage of a standardized protocol that has been used both clinically and in numerous research studies across a wide variety of conditions. Furthermore, MBSR teaches participants a daily practice that, if effective, could serve as a prophylactic intervention.

Conditions
Migraine, Headache
Being tested
Mindfulness Based Stress Reduction (MBSR)
Keywords
Migraines, Behavioral, Complementary and Alternative Medicine, Mindfulness Meditation, Mindfulness Based Stress Reduction
Medical subject headings
Migraine Disorders, Headache, Behavior

What participants receive

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

  • Mindfulness Based Stress Reduction (MBSR)Behavioural

    MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class

Study groups in NCT01545466
Study groupRoleWhat they receive
Mindfulness Based Stress ReductionExperimentalParticipants will complete an 8 week course in Mindfulness Based Stress Reduction (MBSR), meeting once/week for 8 weeks and having a 4-6 hour retreat after the 6th class
Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR)
Wait-List Control GroupNo interventionThese participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.

What is being measured

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

  1. Change in Migraine frequency from Baseline

    Change in the number of migraines per month from baseline(tracked with headache logs)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

Secondary outcomes (10)

  1. Change in self-efficacy from baseline

    Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  2. Change in perceived stress from baseline

    Change in Perceived stress scale from baseline

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  3. Change in migraine-related disability/impact from baseline

    Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  4. Change in anxiety from baseline

    Change in anxiety from baseline (state-trait anxiety measure)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  5. Change in depression from baseline

    Change in depression from baseline(PHQ-9)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  6. Change in mindfulness from baseline

    Change in mindfulness from baseline(Five facet mindfulness scale)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  7. Qualitative interviews

    Participants will be interviewed qualitatively

    Measured: immediately post-intervention

  8. Change in migraine severity from baseline

    Change in Migraine intensity (1-10) tracked via headache logs from baseline

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  9. Change in Migraine duration from baseline

    Length of migraines (tracked via headache logs)

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

  10. Change in quality of life from baseline

    Change in Migraine specific quality of life from baseline

    Measured: baseline, immediately post-intervention, 4 weeks post-intervention

Timeline

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

  1. First posted6 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionOct 2012
  4. Study completionOct 2012

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
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01545466
Sponsor's protocol ID
2011P001654
Status last verified
Mar 2013
First submitted
24 Feb 2012
Last updated
12 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • Wells RE, Burch R, Paulsen RH, Wayne PM, Houle TT, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014 Oct;54(9):1484-95. doi: 10.1111/head.12420. Epub 2014 Jul 18.

    PubMed 25041058

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Stress Reduction (MBSR) in people with Migraine and Headache, run by Brigham and Women's Hospital 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 8 inclusion and 7 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 12 Mar 2013. 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?

Change in Migraine frequency from Baseline (time frame: baseline, immediately post-intervention, 4 weeks post-intervention). 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 NCT01545466, 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 12 Mar 2013.

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