Non-drug Interventions for Migraines

March 11, 2013 updated by: Rebecca Wells, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Based Stress Reduction
Participants 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
Behavioral: Mindfulness Based Stress Reduction (MBSR)
MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class
No Intervention: Wait-List Control Group
These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Migraine frequency from Baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in the number of migraines per month from baseline(tracked with headache logs)
baseline, immediately post-intervention, 4 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-efficacy from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale)
baseline, immediately post-intervention, 4 weeks post-intervention
Change in perceived stress from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in Perceived stress scale from baseline
baseline, immediately post-intervention, 4 weeks post-intervention
Change in migraine-related disability/impact from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6)
baseline, immediately post-intervention, 4 weeks post-intervention
Change in anxiety from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in anxiety from baseline (state-trait anxiety measure)
baseline, immediately post-intervention, 4 weeks post-intervention
Change in depression from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in depression from baseline(PHQ-9)
baseline, immediately post-intervention, 4 weeks post-intervention
Change in mindfulness from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in mindfulness from baseline(Five facet mindfulness scale)
baseline, immediately post-intervention, 4 weeks post-intervention
Qualitative interviews
Time Frame: immediately post-intervention
Participants will be interviewed qualitatively
immediately post-intervention
Change in migraine severity from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in Migraine intensity (1-10) tracked via headache logs from baseline
baseline, immediately post-intervention, 4 weeks post-intervention
Change in Migraine duration from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Length of migraines (tracked via headache logs)
baseline, immediately post-intervention, 4 weeks post-intervention
Change in quality of life from baseline
Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in Migraine specific quality of life from baseline
baseline, immediately post-intervention, 4 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Study Director: Rebecca E Wells, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P001654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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