Clinical trial NCT01545466: Non-drug Interventions for Migraines
Official title: Mindfulness Based Stress Reduction for Adults With Migraines: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Keywords: Migraines
Behavioral
Complementary and Alternative Medicine
Mindfulness Meditation
Mindfulness Based Stress Reduction
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Migraine frequency from Baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
Secondary outcomes:
measure: Change in self-efficacy from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in perceived stress from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in migraine-related disability/impact from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in anxiety from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in depression from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in mindfulness from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Qualitative interviews
timeFrame: immediately post-intervention
measure: Change in migraine severity from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in Migraine duration from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
measure: Change in quality of life from baseline
timeFrame: baseline, immediately post-intervention, 4 weeks post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Rebecca E Wells, MD, MPH
role: STUDY_DIRECTOR
References:
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.