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

Objective 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. Background 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. Methods 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/30 days, average headache attack pain intensity, and attack‐level migraine‐related disability [Migraine Disability Index (MIDI)]) were derived from the daily headache diary. Results 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 ...

Exploring Emotional Distress, Psychological Traits and Attitudes in Patients with Chronic Migraine Undergoing OnabotulinumtoxinA Prophylaxis versus Withdrawal Treatment

“…Conversely, MOH patients undergoing WT reported a high tendency to experiential avoidance, and they also reported higher psychological inflexibility than the population of the AAQ-II validation study, suggesting acceptance and values-based action as relevant psychological dimensions to be fostered through appropriate psychological strategies for patients with MOH. Recently, Acceptance and Commitment Therapy (ACT) showed promising results in reducing adverse impact in chronic pain conditions, including patients with migraine [32,[70][71][72][73].…”

“…The patients definite answer on receiving psychological strategies is a positive starting point to make complementary behavioral interventions available. In the literature, the recognition of the role of psychosocial aspects in migraine is increasing, with a definite interest in psychological approaches to be integrated with pharmacological and medical ones and a growing interest in, and utilization of, complementary and integrative strategies, such as mindfulness-based interventions [37,38,73]. However, a gap between research on the relevance and effectiveness of behavioral treatment interventions and the clinical practice remains [37,77,78].…”

Acceptance and Commitment Therapy (ACT) vs Erenumab for High Frequency Episodic Migraine Without Aura: Time to Take the Gloves Off!

“…People with lower resilience are at risk for greater emotional difficulties such as depression and anxiety, particularly when associated with chronic pain conditions such as migraine. Also, studies on the use of mindfulness and ACT in migraine have demonstrated improvement in patients’ ability to tolerate pain, reduce the use of symptomatic medications and to modulate specific characteristics of the migraine personality (rigidity, low acceptance, and low resilience) . Recently, the calcitonin gene‐related peptide monoclonal antibodies (MAbs), innovative and specific, but costly pharmacological therapies have been introduced and have shown benefit in the management of both episodic and chronic migraine .…”

“…Also, studies on the use of mindfulness and ACT in migraine have demonstrated improvement in patients' ability to tolerate pain, reduce the use of symptomatic medications and to modulate specific characteristics of the migraine personality (rigidity, low acceptance, and low resilience). 1,[7][8][9] Recently, the calcitonin gene-related peptide monoclonal antibodies (MAbs), innovative and specific, but costly pharmacological therapies have been introduced and have shown benefit in the management of both episodic and chronic migraine. 10,11 Real-world experiences with some of these drugs are just being published.…”

Triggers of Primary Headaches: Issues and Pathways Forward

“…52,53 The related approach of Mindfulness-Based Cognitive Therapy seems to also have value for reducing headache disability. [54][55][56] A series of laboratory investigations has been carried out to test the TAMH. Three studies using 3 different empirically validated triggers -visual disturbance, 57 noise, 58 and stress 59 -exposed headache sufferers to triggers for varying durations.…”