590) effect was significant for headache days/30 days. For headache attack days/30 days, neither the group*time ( p =. 589 predicted average headache pain intensity decreased by 0.5 points from Month 0 to Month 4, p =. For headache pain intensity, the group*time interaction was not significant, p =. 027 (Figure 1b) across both groups, the predicted proportion of participants reporting severe disability significantly decreased by 21.6% from Month 0 to Month 4, p <. For the MIDAS, the group*time interaction was not significant, p =. MBCT-M participants reported larger decreases in the HDI than WL/TAU participants, p <. Attrition was not significantly different between the MBCT (n = 6) and WL/TAU (N = 1) groups, p =. Baseline HDI (M = 51.4, SD =19.0), MIDAS (“Severe Disability” n = 50, 83.3%), headache attack days/month (M = 10.4, SD = 5.1) and average headache attack severity (M = 6.2, SD = 1.8) did not differ between groups (Table 1). Approximately half (51.7%) of participants met criteria for CM.
MBCT participants were significantly older than WL/TAU participants no other demographics differed between groups (Table 1). Participants were predominantly White Non-Hispanic women with a graduate degree (Table1). Alpha (.05, two-tailed) was divided equally between the two primary analyses. Non-significant group*time interactions were removed from final models. Intent-to-treat analysis used linear (HDI, headache days/30 days and headache pain intensity) and logistic (MIDAS) mixed models with fixed effects for group, time, and their interaction, and random effects for time and intercept, to evaluate treatment effects. χ2 tests and t-tests compared baseline differences and attrition between groups. Secondary outcomes were changes in self-reported headache days/30 days and headache pain intensity (0-10) from Month 0 to Month 4. Primary outcomes were Month 0 to Month 4 changes in perceived and functional disability. Participants completed outcome evaluations at Months 0, 1, 2 and 4. Those who met criteria were stratified by chronic migraine status (≥15 headache days/month) and randomized to receive either 8 weekly individual 75-minute MBCT-M sessions or 8 weeks of wait list/treatment as usual (WL/TAU). Intake evaluations and a 30-day baseline diary screened inclusion criteria: a) current ICHD-3 diagnosis of migraine b) ≥ 6 headache days/month, c) aged 18-65, d) English-speaking, and e) capacity to consent and exclusion criteria: a) continuous headache b) new preventive treatment b) severe psychiatric illness or c) poor baseline diary adherence (< 26/30 days). Participants were recruited from 7/15 – 9/18 through referrals and ads in the New York City area. This study evaluated the efficacy of Mindfulness-Based Cognitive Therapy tailored for migraine (MBCT-M) to reduce migraine-related disability (NCT02443519). Mindfulness-based interventions have demonstrated efficacy to reduce disability in chronic musculoskeletal pain. 4ġAlbert Einstein College of Medicine, Yeshiva University, Bronx, NY, USA 2West Haven, CT, USA 3Charleston, SC, USA 4Bronx, NY, USA 5Brisbane, Queensland, AUS 6Department of Neurology, NYU Langone Health, New York, NY, USA
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EARLY CAREER AWARD LECTURE Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability? Results from a Phase 2b Pilot Randomized Clinical Trial
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