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

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.

Figure 1.. Overview of Study Design, Conducted for Each Cohort

MBSR indicates mindfulness-based stress reduction. ^aTrained study team members conducted the phone screens, including the principal investigator, master’s-level students, and undergraduate students. ^bParticipants were initially required to be migraine-free for 48 hours prior to each study visit, but to complete the study, this was changed (after cohort 1’s 12-week study visit) to migraine-free the day of study visits (given that participants’ headache frequencies could be up to 20 days per month). See details in Supplement 2. ^cQuestionnaires were completed in-person at the screening visit and in-person or remotely for follow-up visits (when headache-free). ^dAll quantitative sensory testing (QST) assessments were in-person, with confirmation of no pain relieving medications taken within 12 hours. ^eThis run-in period confirmed ability to maintain daily headache log and confirmed eligibility criteria (assessment of migraine frequency and exclusion for medication overuse headache). ^fQualitative interview results will be reported elsewhere.

Figure 2.. CONSORT Flow Diagram of Study Participation

See eTable 5 and eTable 6 in Supplement 1 for details of reasons and time points for exclusion, withdrawal, and lost to follow-up.

Figure 3.. Changes in Well-Being and Experimental Pain Intensity and Unpleasantness Between Mindfulness-Based Stress Reduction (MBSR) and Headache Education

FFM indicates Five Facet Mindfulness; GAD-7, Generalized Anxiety Disorder 7; HIT-6, Headache Impact Test; HMSE, Headache Management Self-Efficacy; MIDAS, Migraine Disability Assessment, one month; MSQv2.1, Migraine Specific Quality of Life; PCS, Pain Catastrophizing Scale; PHQ-9, Patient Health Questionnaire-9 Depression. A, Point estimates of Cohen d effect size differences between treatment groups with 95% CIs, with positive directional effect indicating an improvement in MBSR relative to headache education for each measure. HIT-6 displayed at 3 time points due to a significant treatment-visit interaction. All other instrument treatment effect measures did not significantly differ across visits (P > .05). Cohen d effect sizes of 0.2 are considered small, 0.5 medium, 0.8 large, and 1.2 very large.^, B, Experimental pain measured with quantitative sensory testing, with visual analog scale range of 0-10.