An interventional study of Mindfulness Based Stress Reduction (MBSR) in Migraine and Headache, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-12.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 19 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.
MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class
Change in Migraine frequency from Baseline
Change in the number of migraines per month from baseline(tracked with headache logs)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in self-efficacy from baseline
Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in perceived stress from baseline
Change in Perceived stress scale from baseline
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in migraine-related disability/impact from baseline
Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in anxiety from baseline
Change in anxiety from baseline (state-trait anxiety measure)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in depression from baseline
Change in depression from baseline(PHQ-9)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in mindfulness from baseline
Change in mindfulness from baseline(Five facet mindfulness scale)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Qualitative interviews
Participants will be interviewed qualitatively
Time frame: immediately post-intervention
Change in migraine severity from baseline
Change in Migraine intensity (1-10) tracked via headache logs from baseline
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in Migraine duration from baseline
Length of migraines (tracked via headache logs)
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
Change in quality of life from baseline
Change in Migraine specific quality of life from baseline
Time frame: baseline, immediately post-intervention, 4 weeks post-intervention
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital