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Original Investigation
December 14, 2020

Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial

Author Affiliations
  • 1Comprehensive Headache Program, Department of Neurology, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 2Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 3Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina
  • 4Department of Psychiatry and Behavioral Medicine, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 5Department of Epidemiology & Prevention, Division of Public Health Sciences, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 6Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 7Department of Anesthesiology, University of California, San Diego, La Jolla
  • 8Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston
JAMA Intern Med. 2021;181(3):317-328. doi:10.1001/jamainternmed.2020.7090
Key Points

Question  Does mindfulness-based stress reduction (MBSR) improve migraine outcomes and affective/cognitive processes compared with headache education?

Findings  In this randomized clinical trial of 89 adults who experienced between 4 and 20 migraine days per month, standardized training in mindfulness and yoga through MBSR did not improve migraine frequency more than headache education about migraine, as both groups had similar decreases.

Meaning  Mindfulness meditation may help treat the total burden of migraine, although a larger, more definitive study is needed to further investigate these results to understand the association of mindfulness with migraine outcomes.

Abstract

Importance  Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit.

Objective  To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education.

Design, Setting, and Participants  This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment).

Interventions  Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks.

Main Outcomes and Measures  The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks).

Results  Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: −1.6 migraine days per month; 95% CI, −0.7 to −2.5; headache education: −2.0 migraine days per month; 95% CI, −1.1 to −2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, −9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, −8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol.

Conclusions and Relevance  Mindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, 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. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results.

Trial Registration  ClinicalTrials.gov Identifier: NCT02695498

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    1 Comment for this article
    Mindfulness-based stress reduction vs education
    Arthur Sands, BS, MD | Retired
    Why not try both mindfulness-based stress reduction and headache education ?
    CONFLICT OF INTEREST: None Reported
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