Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability in People with Episodic and Chronic Migraine? A Phase 2b Pilot Randomized Clinical Trial.

Abstract

The current Phase 2b study aimed to evaluate the efficacy of mindfulness-based cognitive therapy for migraine (MBCT-M) to reduce migraine-related disability in people with migraine. Mindfulness-based interventions represent a promising avenue to investigate effects in people with migraine. MBCT teaches mindfulness meditation and cognitive-behavioral skills and directly applies these skills to address disease-related cognitions. Participants with migraine (6-30 headache days/month) were recruited from neurology office referrals and local and online advertisements in the broader New York City area. During the 30-day baseline period, all participants completed a daily headache diary. Participants who met inclusion and exclusion criteria were randomized in a parallel design, stratified by chronic migraine status, to receive either 8 weekly individual MBCT-M sessions or 8 weeks of waitlist/treatment as usual (WL/TAU). All participants completed surveys including primary outcome evaluations at Months 0, 1, 2, and 4. All participants completed a headache diary during the 30-day posttreatment evaluation period. Primary outcomes were the change from Month 0 to Month 4 in the headache disability inventory (HDI) and the Migraine Disability Assessment (MIDAS) (total score≥21 indicating severe disability); secondary outcomes (headache days/30days, average headache attack pain intensity, and attack-level migraine-related disability [Migraine Disability Index (MIDI)]) were derived from the daily headache diary. Sixty participants were randomized to receive MBCT-M (n=31) or WL/TAU (n=29). Participants (M age=40.1, SD=11.7) were predominantly White (n=49/60; 81.7%) and Non-Hispanic (N=50/60; 83.3%) women (n=55/60; 91.7%) with a graduate degree (n=35/60; 55.0%) who were working full-time (n=38/60; 63.3%). At baseline, the average HDI score (51.4, SD=19.0) indicated a moderate level of disability and the majority of participants (50/60, 83.3%) fell in the "Severe Disability" range in the MIDAS. Participants recorded an average of 16.0 (SD=5.9) headache days/30 days, with an average headache attack pain intensity of 1.7 on a 4-point scale (SD=0.3), indicating moderate intensity. Average levels of daily disability reported on the MIDI were 3.1/10 (SD=1.8). For the HDI, mean scores decreased more from Month 0 to Month 4 in the MBCT-M group (-14.3) than the waitlist/treatment as an usual group (-0.2; P<.001). For the MIDAS, the group*month interaction was not significant when accounting for the divided alpha, P=.027; across all participants in both groups, the estimated proportion of participants falling in the "Severe Disability" category fell significantly from 88.3% at Month 0 to 66.7% at Month 4, P<.001. For diary-reported headache days/30 days an average headache attack pain intensity, neither the group*month interaction (Ps=.773 and .888, respectively) nor the time effect (Ps=.059 and .428, respectively) was significant. Mean MIDI scores decreased in the MBCT-M group (-0.6/10), whereas they increased in the waitlist/treatment as an usual group (+0.3/10), P=.007. MBCT-M demonstrated efficacy to reduce headache-related disability and attack-level migraine-related disability. MBCT-M is a promising emerging treatment for addressing migraine-related disability.