Non-drug Interventions for Migraines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca Wells, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01545466
First received: February 24, 2012
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Migraine
Headache
Behavioral: Mindfulness Based Stress Reduction (MBSR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction for Adults With Migraines: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Migraine frequency from Baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in the number of migraines per month from baseline(tracked with headache logs)


Secondary Outcome Measures:
  • Change in self-efficacy from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale)

  • Change in perceived stress from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in Perceived stress scale from baseline

  • Change in migraine-related disability/impact from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6)

  • Change in anxiety from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in anxiety from baseline (state-trait anxiety measure)

  • Change in depression from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in depression from baseline(PHQ-9)

  • Change in mindfulness from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in mindfulness from baseline(Five facet mindfulness scale)

  • Qualitative interviews [ Time Frame: immediately post-intervention ] [ Designated as safety issue: No ]
    Participants will be interviewed qualitatively

  • Change in migraine severity from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in Migraine intensity (1-10) tracked via headache logs from baseline

  • Change in Migraine duration from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Length of migraines (tracked via headache logs)

  • Change in quality of life from baseline [ Time Frame: baseline, immediately post-intervention, 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Change in Migraine specific quality of life from baseline


Enrollment: 19
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545466

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Study Director: Rebecca E Wells, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Rebecca Wells, Instructor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01545466     History of Changes
Other Study ID Numbers: 2011P001654
Study First Received: February 24, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Migraines
Behavioral
Complementary and Alternative Medicine
Mindfulness Meditation
Mindfulness Based Stress Reduction

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014