Migraine, Headache
Conditions
Keywords
Migraines, Behavioral, Complementary and Alternative Medicine, Mindfulness Meditation, Mindfulness Based Stress Reduction
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.
Interventions
MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Migraine frequency from Baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in the number of migraines per month from baseline(tracked with headache logs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews | immediately post-intervention | Participants will be interviewed qualitatively |
| Change in migraine severity from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in Migraine intensity (1-10) tracked via headache logs from baseline |
| Change in Migraine duration from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Length of migraines (tracked via headache logs) |
| Change in self-efficacy from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale) |
| Change in mindfulness from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in mindfulness from baseline(Five facet mindfulness scale) |
| Change in migraine-related disability/impact from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6) |
| Change in anxiety from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in anxiety from baseline (state-trait anxiety measure) |
| Change in depression from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in depression from baseline(PHQ-9) |
| Change in quality of life from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in Migraine specific quality of life from baseline |
| Change in perceived stress from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | Change in Perceived stress scale from baseline |
Countries
United States
Outcome results
None listed