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Non-drug Interventions for Migraines

Primary Purpose

Migraine, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraines, Behavioral, Complementary and Alternative Medicine, Mindfulness Meditation, Mindfulness Based Stress Reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness Based Stress Reduction

Wait-List Control Group

Arm Description

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

These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2012
Last Updated
March 11, 2013
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01545466
Brief Title
Non-drug Interventions for Migraines
Official Title
Mindfulness Based Stress Reduction for Adults With Migraines: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache
Keywords
Migraines, Behavioral, Complementary and Alternative Medicine, Mindfulness Meditation, Mindfulness Based Stress Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction
Arm Type
Experimental
Arm Description
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
Arm Title
Wait-List Control Group
Arm Type
No Intervention
Arm Description
These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class
Primary Outcome Measure Information:
Title
Change in Migraine frequency from Baseline
Description
Change in the number of migraines per month from baseline(tracked with headache logs)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in self-efficacy from baseline
Description
Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in perceived stress from baseline
Description
Change in Perceived stress scale from baseline
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in migraine-related disability/impact from baseline
Description
Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in anxiety from baseline
Description
Change in anxiety from baseline (state-trait anxiety measure)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in depression from baseline
Description
Change in depression from baseline(PHQ-9)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in mindfulness from baseline
Description
Change in mindfulness from baseline(Five facet mindfulness scale)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Qualitative interviews
Description
Participants will be interviewed qualitatively
Time Frame
immediately post-intervention
Title
Change in migraine severity from baseline
Description
Change in Migraine intensity (1-10) tracked via headache logs from baseline
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in Migraine duration from baseline
Description
Length of migraines (tracked via headache logs)
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention
Title
Change in quality of life from baseline
Description
Change in Migraine specific quality of life from baseline
Time Frame
baseline, immediately post-intervention, 4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Wells, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25041058
Citation
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.
Results Reference
derived

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Non-drug Interventions for Migraines

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