Mindfulness Meditation vs. Headache Education for Migraine: A Randomized Clinical Trial (4972)

Objective: Determine if Mindfulness-Based Stress Reduction (MBSR) improves migraine outcomes and affective/cognitive processes compared to Headache (HA) Education.

Background: Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or side effects. Mindfulness meditation may provide benefit.

Design/Methods: Randomized clinical trial of 8 weekly in-person classes of MBSR or HA Education (n=89) in adults with 4–20 migraines/month. Blinding occurred of participants (to active vs. comparator group assignments) and PI/data analysts. Primary outcome: change in migraine day frequency (baseline to 12 weeks). Secondary outcomes: changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, 36 weeks).

Results: Most participants were female (92%), 43.9 years (SD 13.0), with 7.3 (SD 2.7) migraines/month. Participants in both groups had fewer migraine days at 12 weeks (MBSR: −1.6 migraine days/month; 95% CI: [−0.7, −2.5]; HA Education −2.0; [−1.1, −2.9]), without group differences (p=0.51). Compared to HA Education, MBSR participants had improvements from baseline at all time points (on point estimates of effect differences between groups) in disability (5.92 (95% CI 2.8, 9.0) p<0.001); quality of life (5.1 (1.2, 8.9) p=0.01); self-efficacy (8.2 (0.3, 16.1, p=0.04); pain catastrophizing (5.8 (2.9, 8.8), p<0.001); depression scores (1.6 (0.4, 2.7) p=0.008), and decreased experimentally induced pain intensity and unpleasantness (p= 0.004 and 0.005, respectively, at 36 weeks). One reported adverse event was deemed unrelated to study protocol.

Conclusions: MBSR did not improve migraine frequency more than HA Education, as both groups had clinically meaningful decreases. Only MBSR improved disability, quality of life, self-efficacy, pain-catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. MBSR may help treat total migraine burden; a larger more definitive study is needed to further investigate these results.

Disclosure: The institution of Dr. Wells has received research support from NIH. The institution of Dr. Wells has received research support from National Headache Foundation. Dr. Wells has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Practicing Clinician Exchange 2019 Symposia Series 1. Dr. Wells has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Southern Headache Society. Dr. Wells has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Headache Cooperative of New England. Dr. Wells has received personal compensation in the range of $500-$4,999 for serving as a Speaker with WebMD. Dr. Wells has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Wells has received personal compensation in the range of $0-$499 for serving as a Patient Education Day Speaker, Mindfulness Speaker with Miles for Migraine. Nathaniel O'Connell has nothing to disclose. Charles Pierce has nothing to disclose. The institution of Mrs. Estave has received research support from NIDA. Dr. Penzien has received personal compensation for serving as an employee of Wake Forest School of Medicine. The institution of Dr. Penzien has received research support from NIH. The institution of Dr. Penzien has received research support from VA Office of Research and Development. Dr. Loder has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of New England. The institution of Dr. Loder has received personal compensation in the range of $100,000-$499,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for The BMJ. Dr. Loder has received publishing royalties from a publication relating to health care. Fadel Zeidan has nothing to disclose. Timothy Houle has nothing to disclose.