Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine

Abstract

Objective

Evaluate whether the benefits of Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) on headache disability differs among people with episodic and chronic migraine (CM).

Methods

This is a planned secondary analysis of a randomized clinical trial. After a 30-day baseline, participants were stratified by episodic (6–14 d/mo) and CM (15–30 d/mo) and randomized to 8 weekly individual sessions of MBCT-M or wait list/treatment as usual (WL/TAU). Primary outcomes (Headache Disability Inventory; Severe Migraine Disability Assessment Scale [scores ≥ 21]) were assessed at months 0, 1, 2, and 4. Mixed models for repeated measures tested moderation with fixed effects of treatment, time, CM, and all interactions. Planned subgroup analyses evaluated treatment*time in episodic and CM.

Results

Of 60 participants (MBCT-M N = 31, WL/TAU N = 29), 52% had CM. CM moderated the effect of MBCT-M on Severe Migraine Disability Assessment Scale, F(3, 205) = 3.68, p = 0.013; MBCT-M vs WL/TAU reduced the proportion of people reporting severe disability to a greater extent among people with episodic migraine (−40.0% vs −14.3%) than CM (−16.4% vs +8.7%). Subgroup analysis revealed MBCT-M (vs WL/TAU) significantly reduced Headache Disability Inventory for episodic (p = 0.011) but not CM (p = 0.268).

Conclusions

MBCT-M is a promising treatment for reducing headache-related disability, with greater benefits in episodic than CM.

Trial Registration Information

ClinicalTrials.gov Identifier: NCT02443519.

Classification of Evidence

This study provides Class III evidence that MBCT-M reduces headache disability to a greater extent in people with episodic than CM.

Migraine is a prevalent and disabling neurologic disease^1–4 categorized as episodic (<15 headache d/mo) or chronic (≥15 headache d/mo).⁵ Episodic migraine is far more prevalent,⁶ but individuals with chronic migraine (CM) have higher headache disability.^7–10 Existing treatments can reduce headache frequency and disability; however, there is considerable room for improvement on functional outcomes.^11–13

Mindfulness-based cognitive therapy is an 8-week manualized intervention initially developed to reduce depression relapse^14,15 since adapted to treat chronic pain.^16–18 The Bronx Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) phase IIb trial (n = 60) found significant reductions in headache disability after an 8-week treatment phase compared with a wait list/treatment as usual control.¹⁹ MBCT is posited to reduce headache-related disability through daily persistent cultivation of mindfulness and pain acceptance, which have been associated with lower disability in people with chronic pain.^20–23 Given the daily commitment to a treatment designed to reduce disability, MBCT may be more pertinent for people with chronic (vs. episodic) migraine because it is more disabling and has a more frequent headache time course.

This study describes planned secondary analyses of the Bronx MBCT-M trial evaluating whether treatment effects differed in people with episodic and CM. The a priori hypothesis was MBCT-M would result in larger reductions in headache disability compared with the wait list/treatment as usual (WL/TAU) in the chronic vs episodic migraine (EM) group.

Methods

Participants

Participants were recruited from physician referrals, social media, and advertisements in the New York City and tri-state area. Inclusion criteria were (1) meeting migraine diagnostic criteria according to the International Classification of Headache Disorders—3,¹ on interview and in a prospective diary, (2) reporting ≥6 headache days per month but less than daily continuous headache on interview and in a prospective diary, (3) aged 18–65, (4) ability to read English, and (5) capacity to consent. Exclusion criteria were (1) self-reported or diary-confirmed continuous headache, (2) starting a new preventative migraine treatment (within 4 weeks of intake appointment) or planning to start a new preventive migraine treatment during the study, (3) severe psychiatric illness that could interfere with treatment participation, or (4) recording fewer than 26/30 diary days in the baseline monitoring period. Participants who passed an online screener participated in a 1-hour in-person intake assessment conducted by doctoral psychology students supervised by licensed clinical psychologists in New York City. Participants who met the inclusion criteria at the intake assessment and were interested in participating provided written informed consent.

Study Design

This study was designed to provide Class III evidence regarding the relative benefits of MBCT-M (vs. WL/TAU) for people with episodic vs CM. The study ran from July 2015 through September 2018 (NCT02443519). During the baseline evaluation period, all participants completed an app-based daily diary for 30 days (figure 1). Participants who recorded 15 or more days per 30 days with at least one discrete full-criteria migraine attack were classified as CM (following the criteria by Silberstein-Lipton²⁴); participants who recorded 14 or fewer days per 30 days with at least one discrete full-criteria migraine attack were classified as EM. Participants who met the inclusion and exclusion criteria after the baseline evaluation period were randomized in 1:1 ratio in a parallel design, stratified by CM status, to receive 2 months of either MBCT-M or WL/TAU. Computerized stratified block randomization with random block sizes was used by a researcher not otherwise connected to the study to generate randomization lists given to a research assistant in opaque, sealed envelopes. Neither participants nor researchers were blinded to allocation after randomization.

Figure 1. Study Design.

CM = chronic migraine; MBCT = mindfulness-based cognitive therapy; WL/TAU = wait-list/treatment-as-usual.

Participants completed online surveys at months 0, 1, 2, and 4. Participants completed an app-based daily diary during the 30-day posttreatment evaluation period. All data were captured using REDCap,²⁵ a Health Insurance Portability and Accountability Act-compliant online data capture system. Participants received up to $70 for measure completion. Additional study details are reported in the primary outcomes manuscript.¹⁹

Standard Protocol Approvals, Registrations, and Patient Consents

This protocol was approved by the Albert Einstein College of Medicine Internal Review Board (2015–4684). All participants provided written informed consent. This trial was prospectively registered at clinicaltrials.gov (NCT02443519).

Interventions

MBCT-M was a standardized treatment protocol adapted from the mindfulness-based cognitive therapy for chronic headache pain protocol.¹⁶ The protocol included 8 individual, 75-minute, weekly sessions administered over 8–10 weeks. Session topics were (1) Automatic Pilot, (2) Awareness of Appraisals and Stress, (3) Mindfulness of the Breath, (4) Recognizing Aversion, (5) Allowing/Letting Be, (6) Thoughts are Not Facts, (7) How Can I Best Take Care of Myself? And (8) Using Mindfulness to Cope with Migraine. Each session included education about a mindfulness concept and its applied relevance to migraine management, thought exercises designed to help the participant incorporate mindfulness into cognitive appraisals particularly about migraine, and experiential mindfulness meditation practices designed to systematically increase mindfulness skills. Homework included formal and informal mindfulness practices (e.g., breath awareness meditation), mindfulness-based cognitive exercises, identification of migraine and stress warning signs, and planning nourishing activities. Most sessions were conducted in-person at the Bronx, NY, or Manhattan, NY, research sites. However, migraine is characterized by unpredictable disabling attacks; therefore, we permitted up to 3 of 8 sessions to occur over the phone to avoid extending the treatment period beyond 10 weeks. Doctoral-level clinical psychology graduate students were the study therapists. Three psychologists with specific expertise in mindfulness-based cognitive therapy (M.A.D.) and migraine behavioral treatment (E.K.S. and D.C.B.) supervised 2 6-hour training sessions. Two licensed clinical psychologists (ES and DB) provided individual weekly supervision and monthly group supervision with all study therapists.

Participants randomized to the WL/TAU group did not receive treatment beyond their standard migraine care and did not complete the headache diary during the treatment period. Participants in the WL/TAU condition were offered the 8-week treatment program after completion of the 4-month study protocol.

Measures

All surveys were administered through REDCap, an online data capture system. Research assistants had no role in administering surveys. Study staff did not examine survey data until a subject's participation in the study had concluded. In a baseline survey, participants reported age, sex, ethnicity, race, employment status, education, and marital status. Participants also reported all medications taken currently. Outcomes included the following:

Primary Outcomes

The Migraine Disability Assessment Scale^26,27 is a 5-item measure that assesses the impact of migraine on occupational/academic work, household work, and social/leisure activities. Items include “On how many days in the last 3 months did you not do household work (such as housework, home repairs and maintenance, shopping, caring for children and relatives) because of your headaches?” The Migraine Disability Assessment Scale produces a skewed count; therefore, for analysis, Migraine Disability Assessment Scale score was dichotomized at 21, which is the clinical cutoff indicating “Severe Disability.”²⁸ The Migraine Disability Assessment Scale has demonstrated reliability and validity in previous studies²⁶; it demonstrated adequate internal consistency in the current sample, α = 0.76.

The Henry Ford Hospital Headache Disability Inventory²⁹ is a 25-item measure that assesses the perceived impact of headache. Items include “Because of my headaches, I feel restricted in performing my routine daily activities.” Total scores range from 0 to 100; higher scores indicate higher headache-related disability. In previous studies, the Headache Disability Inventory has demonstrated reliability and validity^29,30; it demonstrated excellent internal consistency in this sample, α = 0.90.

Secondary Outcomes

The daily headache diary was delivered via a research app which interfaces with REDCap to provide secure data capture on iOS devices. Participants either used their own personal iOS device or used a device provided by the study. Diary-derived outcomes included the following:

Headache Days/30 Days

Participants would indicate whether they had experienced a headache each day. Headache days were summed over the 30-day baseline monitoring period and 30-day posttreatment evaluation period.

Average Headache Attack Pain Intensity/30 Days

On each headache day, participants were asked to report “How severe was the pain?” with response options of 1 = “Mild,” 2 = “Moderate,” and 3 = “Severe.” These scores were averaged over the 30-day baseline monitoring period and 30-day posttreatment evaluation period.

The Migraine Disability Index was administered on each headache day. The Migraine Disability Index is a 4-item scale designed to assess the extent to which the headache attack interfered with family, social, recreational, and occupational functioning,³¹ with response options ranging from 0, “not at all,” to 10, “totally.” Responses to the 4 items are averaged to obtain a day-level score ranging from 0-10. In previous studies, the Migraine Disability Index demonstrated good reliability and validity^30,32; in this study, it demonstrated excellent internal consistency, α = 0.91. Migraine Disability Index scores were averaged over the 30-day baseline monitoring period and 30-day posttreatment evaluation period.

Analyses

The distribution and measures of central tendency for all study variables were inspected and described. Day-level missing diary data points (15.5%) were singly-imputed by obtaining estimates using mixed models for repeated measures analysis with fixed effects of treatment, month, day, and all of their interactions, and random effects of intercept and day*month. Mixed models for repeated measures produce remarkably unbiased estimates using simulated clinical trial data.^33–35 Baseline differences in demographics and outcomes between treatment group (MBCT-M vs WL/TAU) and CM vs EM were evaluated using t-tests for independent samples or chi-square analyses with continuity correction.

Formal intent-to-treat moderation analyses were conducted to evaluate whether CM status moderated the effect of MBCT-M vs WL/TAU on each outcome. Linear (Headache Disability Inventory, headache days/30 days, average headache attack pain intensity/30 days, Migraine Disability Index) and logistic (Migraine Disability Assessment Scale severe disability) mixed effect models for repeated measures evaluate changes in primary outcomes by treatment group and CM status. Fixed effects were MBCT-M, time, CM, and all interactions. For Headache Disability Inventory and Migraine Disability Assessment Scale, time was a 4-level variable (month 0, 1, 2, and 4); for diary data, time was a two-level variable (baseline monitoring period vs posttreatment evaluation period). Random effects were individual intercepts and time. A significant three-way interaction between MBCT-M*time*CM indicated the MBCT-M treatment effect differed among people with chronic and EM. Planned subgroup analyses were conducted within the chronic and EM groups if formal moderation was not detected. Fixed effects were MBCT-M, time, and their interaction. Random effects were individual intercepts and time. A significant interaction between MBCT*time indicated a significant treatment effect within that subgroup. For all mixed effects models, visual inspection and the Akaike Information Criterion indicated time be modeled using a first-order autoregressive covariance structure. All analyses were run unadjusted and adjusted for age.

Sample size was determined using a priori power analyses for the primary outcome analysis evaluating MBCT-M vs WL/TAU for the Headache Disability Inventory and Migraine Disability Assessment Scale described in the primary outcome study.¹⁹ Because this study describes secondary analyses, all tests were two-tailed with alpha set at 0.05. SPSS version 25.0 was used to analyze the data.

Data Availability

Study protocol and statistical analysis will be made available on clinicaltrials.gov. Deidentified study data will be made available from the first author by request.

Results

Participant Characteristics

Figure 2 describes the study flow by CM status. Of the 160 participants who were evaluated for eligibility, 31 participants with CM and 29 participants with EM were randomized to receive MBCT-M (n = 31; CM = 16, EM = 15) or WL/TAU (n = 29; CM = 15, EM = 14). Attrition did not significantly differ across groups (MBCT-M = 2; WL/TAU = 3; p = 0.938) or CM status (EM = 3; CM = 2; p = 0.938).

Figure 2. Study Flow.

Across the total sample, participants were predominantly non-Hispanic White women with a graduate degree (table 1). Participants randomized to receive MBCT-M were significantly younger (than participants randomized to receive WL/TAU). As reported previously,¹⁹ no other demographics differed by treatment group. Demographics did not differ by CM status (table 1).

Table 1.

Baseline Participant Characteristics by Chronic Migraine Status

Baseline differences in outcomes by CM status are reported in table 1. At baseline, people with CM reported higher levels of headache disability on the Headache Disability Inventory than people with EM, both of which fell in the moderate disability range. Most chronic and EM participants fell in the “Severe Disability” range on the Migraine Disability Assessment Scale. Approximately, half of both the chronic and EM groups reported using preventive migraine medication. On average, people with CM recorded a higher headache attack frequency during a 30-day daily diary than people with EM. Average headache attack pain intensity and attack-level disability did not differ by CM status (table 2).

Table 2.

Chronic Migraine Status Moderates MBCT-M Effect on Severe Migraine Disability Assessment Scale

Headache Disability: Primary Outcomes

For severe Migraine Disability Assessment Scale, CM status formally moderated the treatment effect of MBCT-M, MBCT-M*month*CM, modifying significant effects of MBCT-M*month and month (figure 3; table 2). The estimated proportion of people reporting severe disability reduced the most among people with EM who received MBCT-M (−40.0%). The reduction in estimated proportion of people reporting severe disability was similar among people with CM who received MBCT-M (−16.4%) and people with EM who received WL/TAU (−14.3%). The estimated proportion of people reporting severe disability increased slightly in people with CM who received WL/TAU (+8.7%). Adjusting for age did not modify the interaction (table 2). For CM, the number needed to treat to move from Severe Disability (Migraine Disability Assessment Scale score ≥21) to Not Severe Disability (Migraine Disability Assessment Scale score <21) from month 0 to month 4 was 5.3 with an absolute risk reduction of 18.9%. For EM, the number needed to treat was 1.6 with an absolute risk reduction of 63.6%.

Figure 3. Reductions in “Severe Disability” on the Migraine Disability Assessment (MIDAS; Scores ≥ 21) by Treatment Group and Month Moderated by CM Status.

(CM = Chronic Migraine; EM = Episodic Migraine). Model Estimated Values Depicted.

For the Headache Disability Inventory, CM status did not formally moderate the treatment effect of MBCT-M (MBCT-M*CM*month 0 vs month 4 estimate = −2.19, 95% confidence interval [CI] = −18.10, 13.72). Subgroup analysis revealed that among participants with EM, the MBCT-M*month effect was significant (figure 4A, table 3). Among participants with EM, the reduction in Headache Disability Inventory score month 0 to month 4 was larger in the MBCT-M group (−14.4 points) than the WL/TAU group (−2.0 points; estimate = −14.65, 95% CI = −23.49, −5.81; figure 2). However, among participants with CM, the group*month effect was not significant (table 3). These results did not differ when adjusted for age (table 3). For CM, the number needed to treat to achieve a clinically important decrease of 10 points on the Headache Disability Inventory from month 0 to month 4 was 5.3 with an absolute risk reduction of 18.8%. For EM, the number needed to treat was 1.7 with an absolute risk reduction of 60.0%.

Figure 4. Reductions in A) Mean Headache Disability Inventory (HDI), B) Mean Migraine Disability Index (MIDI)/30 Days, C) Mean Headache Days/30 Days, and D) Mean Attack Pain Intensity/30 Days Among The Chronic Migraine (CM) and Episodic Migraine (EM) Subgroups by Treatment Group and Month.

Model estimated values depicted.

Table 3.

MBCT-M Effect on Disability and Migraine Outcomes in Chronic and Episodic Migraine Subgroups

Day-level Migraine Disability

For diary-reported attack-level migraine-related disability (Migraine Disability Index), CM status did not formally moderate the treatment effect of MBCT-M (group* CM*month 0 vs month 4 estimate = −1.10, 95% CI = −2.34, 0.16); figure 4B. Subgroup analysis revealed that MBCT-M significantly decreased Migraine Disability Index scores vs WL/TAU (−0.31 vs +0.36; estimate = −0.7, 95% CI = −1.3, −0.1) in only the CM group (table 3). Although the magnitude of the decrease in Migraine Disability Index scores was qualitatively larger in the EM group (−0.79), the WL/TAU group experienced a smaller increase in Migraine Disability Index scores (+0.29); therefore, the difference between groups was not statistically significant—F(1, 25.76) = 3.18, p = 0.086; estimate = −1.1, 95% CI = −2.3, 0.2. These results did not differ when adjusted for age (table 3).

Migraine Symptoms

For diary-reported headache days/30 days, CM status did not formally moderate the treatment effect of MBCT-M (group*CM*month 0 vs month 4 estimate = −0.64, 95% CI = −5.10, 3.81); figure 4C. Subgroup analysis revealed no significant group*month effect among participants with EM, F(1, 26.87) = 0.08, p = 0.787, or among participants with CM, F(1, 27.35) = 0.004, p = 0.948 (table 3).

For diary-reported average headache attack pain intensity, CM status did not formally moderate the treatment effect of MBCT-M (group*CM*month 0 vs month 4 estimate = −0.003, 95% CI = −0.23, 0.22); figure 4D. Subgroup analysis revealed no significant group*month effect among participants with episodic or CM (table 3).

The results for headache days/30 days and average headache attack pain intensity/30 days did not differ when adjusted by age (table 3).

Discussion

These secondary analyses of a Phase 2b randomized clinical trial¹⁹ found that for both primary outcomes, the reduction in headache-related disability for MBCT-M vs WL/TAU was significant and larger in magnitude for people with EM compared with people with CM for whom this effect was nonsignificant. This finding is the opposite of our hypothesis and has several important implications for clinical practice and our theoretical understanding of the relationship between headache days and disability, and which patients most benefit from behavioral interventions focused on disability reduction.

This study demonstrates that headache attack frequency can be decoupled from headache disability in people with migraine. In other disease states (such as chronic lower back pain), it is common for behavioral interventions to target functional measures (such as pain interference) rather than disease activity. This is less common in migraine, where behavioral interventions typically target attack frequency and disability concomitantly. Migraine attacks occur in distinct episodes; therefore, disability is proximally related to disease activity (for example, it is difficult to be effective at work during an active migraine attack). In the current study, we saw treatment-related reductions in headache-related disability with no concomitant reductions in headache days. This was true even for the Migraine Disability Assessment Scale, a headache disability scale whose unit of measure is headache disability day, partially confounding headache days and disability. Ongoing assessment of both headache days per month and headache-related disability is essential in clinical practice. It is important to provide patients with migraine-effective strategies to reduce migraine activity; however, many patients still experience substantial disability even when using evidence-based prevention strategies. Treatments such as MBCT-M have utility in reducing headache-related disability and have the potential to meet this clinical need.

Contrary to our hypothesis, people with lower headache frequency (EM) experienced greater benefit from MBCT-M for both primary measures of headache disability than people with higher headache frequency (CM). This finding has theoretical and clinical implications. It is possible that there is a migraine symptom or migraine disability threshold after which meaningful reductions in disability cannot be attained without at least some reduction in migraine symptoms themselves. Participants with severe, refractory disease may feel disempowered, have lower expectations that treatment will be useful, and have less capacity to meaningfully engage in treatment activities, reducing the impact of treatment on outcomes. This treatment did not reduce headache days or average attack headache pain intensity. If this is the case, migraine preventive treatments that reduce both migraine symptoms and disability should be the first-line treatment for CM, whereas treatments that focus explicitly on headache disability reduction may be appropriate for patients with less frequent and severe migraine attacks who experience high levels of headache disability. It should be noted that approximately half (44.8%) of people classified as EM during the baseline run-in period were already taking preventive medication to reduce attack frequency; MBCT-M may also help patients who have experienced some effective prevention learn how to capitalize on that treatment gain to reduce disability.

The results differed slightly for day-level disability (Migraine Disability Index) compared with the 2 coprimary outcomes that were retrospective recall-based measures of headache disability (Headache Disability Inventory and Migraine Disability Assessment Scale). The Migraine Disability Index assessed the average extent to which headache kept the respondent from engaging in 4 categories of daily activities (paid and unpaid jobs, household tasks, leisure, and social) aggregated across 1 month of attacks. Reductions in this measure were significant for MBCT-M vs WL/TAU only in people EM. This is the opposite pattern than observed on the Headache Disability Inventory, in which people with CM reported significantly higher levels of disability than people with EM. It is possible that MBCT-M confers greater benefit to reduce attack-level disability in people with EM compared with CM. However, at baseline, people with EM reported nominally higher levels of disability on each attack day (0.90/10 points). This baseline difference, combined with a slightly smaller wait list effect in the CM group, likely contributed to the pattern of results observed in this analysis. Future studies should continue to evaluate discrepancies between retrospective aggregate levels of migraine disability compared to day-level migraine disability among people with EM and CM.

Participants were predominantly highly educated White women; this is a common population distribution seen in both migraine trials and trials of mindfulness-based interventions. Despite offering 2 locations across a large ethnically diverse city, we were unable to increase the diversity of our sample in race and socioeconomic status. Future studies should consider early engagement of community stakeholders, community-based dissemination of mindfulness interventions, and other adjustments that may help facilitate participation by diverse populations to increase our knowledge about the efficacy of these interventions for migraine in racial and ethnic minority groups and people from a range of socioeconomic status.

We used current headache frequency based on a 30-day daily diary as the criteria for CM status. However, during intake interviews, many EM participants described a history of high frequency headache. This is borne out by the fact that 13 of 29 (44.8%) of our EM participants were currently taking a preventive migraine medication, which did not significantly differ from the preventive medication rate in the CM group. This limited our ability to differentiate between people with EM who have no history of CM and people with current EM who have effectively managed CM. Future studies should specifically plan to evaluate reductions in headache disability with MBCT-M in these two groups of people with current EM.

Data collected were based on patient self-report. Outcomes of interest (disability and migraine symptoms) are inherently subjective. Day-level outcome measures and patient adherence to treatment protocol were collected using an electronic daily diary with a limited entry time frame to reduce the risk of biases related to retrospective recall.

The results should be interpreted in the context of a secondary analysis of an early stage trial. The sample size (n = 60) was underpowered to detect small or medium effects for 3-way interactions. To mitigate this, we included both 3-way interactions and planned subgroup analyses. We also elected not to adjust analyses of the coprimary study outcomes (Headache Disability Inventory and Migraine Disability Assessment Scale) for multiple comparisons to minimize the possibility of a type II error; however, this increases the likelihood of a type I error.

Although all study participants were stable on preventive migraine treatment throughout the study, they were permitted to change acute medication throughout the course of the study, which could affect disease activity and disability.

The study has several strengths. This was a randomized clinical trial using a standardized manualized treatment protocol. Treatment fidelity was supported through a rigorous protocol to reduce therapist drift, and fidelity was closely monitored by study staff otherwise unassociated with the study.¹⁹ Outcomes were commonly used well-validated measures of headache disability and symptoms.

The results from this study highlight the differences between existing evidence-based behavioral strategies for migraine prevention (biofeedback, relaxation, and targeted cognitive behavioral treatments), which have demonstrated robust effects on migraine symptoms and headache disability, and newer mindfulness-based approaches which have smaller effects on migraine symptoms but similarly large effects on headache-related disability. Unlike existing evidence-based behavioral migraine management strategies which teach lifestyle changes believed to directly affect migraine attack frequency, MBCT-M is designed to help people with migraine reduce disability through teaching mindfulness techniques to help disentangle the presence and anticipation of migraine attacks from suffering and disability. For people with migraine who are currently experiencing a large number of headache days per month, behavioral treatment strategies that have demonstrated efficacy for migraine day reduction may be more appropriate than MBCT-M. However, for people reporting high levels of migraine-related disability despite relatively less frequent headache days, a mindfulness-based treatment such as MBCT-M may be an acceptable and appropriate treatment choice. Future studies should evaluate the benefit of combining MBCT-M strategies with evidence-based behavioral and pharmacologic approaches designed to reduce migraine attack frequency.

Classification of Evidence

This study provides Class III evidence that MBCT-M (8 individual 75-min sessions) reduces the proportion of people with severe disability (Migraine Disability Assessment Scale Score ≥21) compared with a WL/TAU control to a greater extend in people with EM (−40.0% vs −14.3%) than people with CM (−16.4% vs +8.7%; Estimate = −6.03, 95% CI = −11.30, −0.76).

TAKE-HOME POINTS

• → MBCT-M is a promising treatment to reduce headache-related disability in people with migraine.

• → MBCT-M may be more beneficial for reducing overall headache-related disability in people with episodic (vs chronic) migraine.

• → MBCT-M does not seem to have a significant impact on headache days/30 days or average attack pain intensity in either episodic or chronic migraine.

Appendix. Authors

Study Funding

Supported by the NIH (NS 096107), the International Headache Academy, and the Hollander Seed Fund at Yeshiva University.

Disclosure

E.K. Seng receives research support from the NINDS (K23 NS096107 PI: Seng) and has consulted for GlaxoSmithKline, Eli Lilly, and Click Therapeutics; she has received travel funds from the American Psychological Association, the American Academy of Neurology, the American Association of Pain Medicine Foundation, and the American Headache Society. A.B. Conway reports no disclosures relevant to the manuscript. C. Metts is the developer of the status/postmobile application used in this study. Development was conducted in his role as President of Infinite Arms, LLC, which maintains ownership of the Intellectual Property associated with this manuscript. A.S. Grinberg reports no disclosures relevant to the manuscript. Z.S. Patel reports no disclosures relevant to the manuscript. M. Marzouk reports no disclosures relevant to the manuscript. L. Rosenberg reports no disclosures relevant to the manuscript. M.A. Day reports no disclosures relevant to the manuscript. M.T. Minen has received grant support from the NIH, the American Academy of Neurology, the American Brain Foundation, the National Multiple Sclerosis Society and from internal grants from NYU. She has also received honorarium from the American Academy of Neurology, the National Headache Foundation, and Barnard College; has received travel funds to attend meetings from the American Headache Society and the American Academy of Neurology; and serves as Co-Section Head of the Headache Section of Pain Medicine as an Associate Editor of the journal Headache. D.C. Buse has received grant support and honoraria from Allergan, Amgen/Novartis, Avanir, Biohaven, Dr. Reddy's Laboratories/Promius Pharma, Eli Lilly, and Teva and for serving on the editorial board of Current Pain and Headache Reports. R.B. Lipton receives grant support from the National Institutes of Health, the National Headache Foundation, and the Migraine Research Fund and serves as consultant, serves as an advisory board member, or has received honoraria from Alder, Allergan, American Headache Society, Autonomic Technologies, Boston Scientific, Bristol Myers Squibb, Cognimed, CoLucid, Dr. Reddy's Laboratories/Promius, Eli Lilly, eNeura Therapeutics, Merck, Novartis, Pfizer, and Teva, Inc. He receives royalties from Wolff's Headache, 8th Edition (Oxford University Press, 2009). He has stock options in eNeura and Biohaven. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp.