Faculty Bibliography

OBJECTIVES/OBJECTIVE:We conducted focus groups in people who had participated in mobile health (mHealth) studies of behavioral interventions for migraine to better understand: (a) Participant experience in the recruitment/enrollment process; (b) participant experience during the studies themselves; (c) ideas for improving participant experience for future studies. METHODS:We conducted four focus groups in people who had agreed to participate in one of three studies involving mHealth and behavioral therapy for migraine. Inclusion criteria were being age 18-80, owning a smartphone, and having four or more headache days per month. All participants met the International Classification of Headache Disorders third edition beta version criteria for migraine. Exclusion criteria were not speaking English and having had behavioral therapy for migraine in the past year. Focus groups were audio recorded, fully transcribed and coded using general thematic analysis. RESULTS:(ii) Enrollment should be simple and study requirements should be carefully explained prior to enrollment. When asked about their experiences during the studies (b), the following themes emerged: (i) It is difficult to participate in study follow-up and compliance phone calls; (ii) participants prefer to choose from among various options for contact with the study team; (iii) there are barriers that limit app use related to migraine itself, as well as other barriers; (iv) completing diaries on a daily basis is challenging; (v) technical difficulties and uncertainties about app features limit use; (vi) being part of a research study promoted daily behavioral therapy use; (vii) progressive muscle relaxation (PMR) is enjoyable, and has a positive impact on life; (viii) behavioral therapy was a preferred treatment to reduce migraine pain. Ideas for improving study design or patient experience (c) included: (i) Increased opportunity to interact with other people with migraine would be beneficial; (ii) navigating the app and data entry should be easier; (iii) more varied methods for viewing the data and measures of adherence are needed; (iv) more information on and more varied behavioral treatment modalities would be preferred. CONCLUSION/CONCLUSIONS:Though people with migraine are motivated to participate in mHealth and behavioral treatment studies, better communication up front about interventions as well as greater flexibility in interventions and follow-up methods are desired.

OBJECTIVE:To estimate the prevalence of having at least one or two or more chronic health conditions among US adults with self-reported migraine or severe headaches. DESIGN/METHODS:Cross-sectional study. METHODS:Using data collected from the 2013-2015 National Health Interview Survey, we examined adults with and without migraine or severe headache and associations with chronic obstructive pulmonary disease, cancer, heart disease, stroke, diabetes, and hypertension. We calculated point estimates, variances, and 95% confidence intervals and conducted bivariate and multivariable logistic regression modeling to examine the relationships between migraine or severe headache and each of the chronic health conditions, as well as multinomial modeling, to examine the relationship between migraine or severe headache and having one or more chronic health conditions. RESULTS:A total of 104,926 people were in the study. Adults aged 18 to 44 years (18.2%), women (20.1%), and those with some college education (17.6%) had the greatest proportion with migraine or severe headache (P < 0.0001). Using multinomial modeling with the number of chronic health conditions as the dependent variable, adults reporting migraine had an increased odds of reporting a single chronic health condition (adjusted odds ratio [aOR] = 1.7, 95% confidence interval [CI] = 1.6-1.8) and more than double the odds of reporting two or more chronic health conditions (aOR = 2.5, 95% CI = 2.3-2.8) compared with adults who did not have migraine or severe headache. CONCLUSIONS:Our study confirms observed relationships between migraine or severe headache and chronic health conditions and supports the need for further research to uncover the shared biological pathways.

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 MBCT-M group (-0.6/10), whereas they increased in the waitlist/treatment as an usual group (+0.3/10), P = .007. CONCLUSIONS: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.

The current planned secondary analysis of a randomized clinical trial aimed to evaluate whether the efficacy of Mindfulness-Based Cognitive Therapy for Migraine (MBCTM) to reduce headache-related disability differs among people with episodic migraine (EM) and chronic migraine (CM). After a 30-day monitoring period, participants were stratified by EM (6-14 days/month) and CM (15-30 days/month) and randomized to receive MBCT-M (8 weekly individual sessions) or 8 weeks of wait list/treatment as usual (WL/TAU). Surveys were completed at Months 0, 1, 2, and 4; daily diary was also completed during the 30-day post-treatment evaluation period. Primary outcomes were the Headache Disability Inventory (HDI; Range 0-100) and the Migraine Disability Assessment (MIDAS >= 21 indicating Severe Disability); secondary outcomes (headache days/30 days, average headache attack pain intensity) were derived from daily headache diary. Intent-to-treat mixed models for repeated measures tested formal moderation (time*treatment*CM) in the full sample. Planned subgroup analyses evaluated treatment*time effects EM and CM separately. 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%), Non-Hispanic (N = 50/60; 83.3%) women (n = 55/60; 91.7%). At baseline, 29 participants (48.3%) met criteria for EM and 31 (51.7%) met criteria for CM. At baseline, people with CM reporter higher HDI [M(SD) = 57.6 (16.7) vs. 45.5 (19.4), p = .015] and greater headache days/30 days [M(SD) = 20.5 (3.0) vs 11.2 (4.2), p < .001]; no other variable differed by CM status (ps > .30). For the MIDAS, CM status moderated the effect of MBCTM on the MIDAS; MBCT-M reduced the proportion of people reporting severe disability in EM only, p = .013. For the HDI, subgroup analysis revealed that MBCT-M (vs WL/TAU) significantly reduced HDI for EM (p = .011) but not for CM (p = .268). Subgroup analysis found no significant effect of MBCT-M on headache days/30 days or average headache attack pain intensity in either EM or CM. MBCT-M is a promising treatment for reducing disability. Surprisingly, MBCT-M produced larger changes on both primary outcomes in the EM, rather than CM, subgroup

BACKGROUND:Migraine is a chronic disabling neurologic condition that can be treated with a combination of both pharmacologic and complementary and integrative health options. EVIDENCE ACQUISITION/METHODS:With the growing interest in the US population in the use of nonpharmacologic treatments, we reviewed the evidence for supplements and behavioral interventions used for migraine prevention. RESULTS:Supplements reviewed included vitamins, minerals, and certain herbal preparations. Behavioral interventions reviewed included cognitive behavioral therapy, biofeedback, relaxation, the third-wave therapies, acupuncture, hypnosis, and aerobic exercise. CONCLUSIONS:This article should provide an appreciation for the wide range of nonpharmacologic therapies that might be offered to patients in place of or in addition to migraine-preventive medications.

BACKGROUND:Migraine and epilepsy are comorbid conditions. While it is well known that epilepsy can have an impact on cognitive abilities, there is conflicting evidence in the literature on the relationship between migraine and cognitive function. The aim of this study was to assess whether migraine comorbidity in patients with newly diagnosed focal epilepsy is associated with cognitive dysfunction. METHODS:This is a post hoc analysis of data prospectively collected for the Human Epilepsy Project (HEP). There were 349 participants screened for migraine with the 13 questions used in the American Migraine Prevalence and Prevention (AMPP) study. Participants were also screened for depression using the Neurological Disorder Depression Inventory for Epilepsy (NDDI-E) and the Center for Epidemiologic Studies Depression Scale (CES-D) and for anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale. Cognitive performance was assessed with the Cogstate Brief Battery and Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS). RESULTS:About a fifth (21.2%) of patients with a new diagnosis of focal epilepsy screened positive for migraine. There were more women and less participants employed full time among the participants with comorbid migraine. They reported slightly more depressive and anxious symptoms than the participants without migraine. Migraine comorbidity was associated with ABNAS memory score (median: 2, range: 0-12, Mann Whitney U p-value: 0.015). However, migraine comorbidity was not associated with Cogstate scores nor ABNAS total scores or other ABNAS domain scores. In linear regressions, depression and anxiety scores were associated with the ABNAS memory score. CONCLUSION/CONCLUSIONS:In this study, there was no association between migraine comorbidity and objective cognitive scores in patients with newly diagnosed focal epilepsy. The relationship between migraine comorbidity and subjective memory deficits seemed to be mediated by the higher prevalence of depression and anxiety symptoms in patients with epilepsy with comorbid migraine.

OBJECTIVE:/UNASSIGNED:Despite the potential benefits of mobile mental health apps, real-world results indicate engagement issues because of low uptake and sustained use. This review examined how studies have measured and reported on user engagement indicators (UEIs) for mental health apps. METHODS:/UNASSIGNED:A systematic review of multiple databases was performed in July 2018 for studies of mental health apps for depression, bipolar disorder, schizophrenia, and anxiety that reported on UEIs, namely usability, user satisfaction, acceptability, and feasibility. The subjective and objective criteria used to assess UEIs, among other data, were extracted from each study. RESULTS:/UNASSIGNED:Of 925 results, 40 studies were eligible. Every study reported positive results for the usability, satisfaction, acceptability, or feasibility of the app. Of the 40 studies, 36 (90%) employed 371 indistinct subjective criteria that were assessed with surveys, interviews, or both, and 23 studies used custom subjective scales, rather than preexisting standardized assessment tools. A total of 25 studies (63%) used objective criteria-with 71 indistinct measures. No two studies used the same combination of subjective or objective criteria to assess UEIs of the app. CONCLUSIONS:/UNASSIGNED:The high heterogeneity and use of custom criteria to assess mental health apps in terms of usability, user satisfaction, acceptability, or feasibility present a challenge for understanding real-world low uptake of these apps. Every study reviewed claimed that UEIs for the app were rated highly, which suggests a need for the field to focus on engagement by creating reporting standards and more carefully considering claims.

Objective/UNASSIGNED:Scalable nonpharmacologic treatment options are needed for chronic pain conditions. Migraine is an ideal condition to test smartphone-based mind-body interventions (MBIs) because it is a very prevalent, costly, disabling condition. Progressive muscle relaxation (PMR) is a standardized, evidence-based MBI previously adapted for smartphone applications for other conditions. We sought to examine the usability of the RELAXaHEAD application (app), which has a headache diary and PMR capability. Methods/UNASSIGNED:Using the "Think Aloud" approach, we iteratively beta-tested RELAXaHEAD in people with migraine. Individual interviews were conducted, audio-recorded, and transcribed. Using Grounded Theory, we conducted thematic analysis. Participants also were asked Likert scale questions about satisfaction with the app and the PMR. Results/UNASSIGNED:Twelve subjects participated in the study. The mean duration of the interviews (SD, range) was 36 (11, 19-53) minutes. From the interviews, four main themes emerged. People were most interested in app utility/practicality, user interface, app functionality, and the potential utility of the PMR. Participants reported that the daily diary was easy to use (75%), was relevant for tracking headaches (75%), maintained their interest and attention (75%), and was easy to understand (83%). Ninety-two percent of the participants would be happy to use the app again. Participants reported that PMR maintained their interest and attention (75%) and improved their stress and low mood (75%). Conclusions/UNASSIGNED:The RELAXaHEAD app may be acceptable and useful to migraine participants. Future studies will examine the use of the RELAXaHEAD app to deliver PMR to people with migraine in a low-cost, scalable manner.

BACKGROUND:There are no clear guidelines on how to treat posttraumatic headache (PTH) or post-concussive symptoms (PCS). However, behavioral interventions such as cognitive behavioral therapy, biofeedback, and relaxation are Level-A evidence-based treatments for headache prevention. To understand how to develop and study further mind-body interventions (MBIs) and behavioral therapies for PTH and PCS, we developed the following question using the PICO framework: Are behavioral therapies and MBIs effective for treating PTH and PCS? METHODS:We conducted a systematic search of 3 databases (Medline, PsycINFO, and EMBASE) for behavioral interventions and MBIs with the subject headings and keywords for PTH, concussion, and traumatic brain injury (TBI). Inclusion criteria were (1) randomized controlled trials, (2) the majority of the intervention had to be behavioral or mind-body therapy focused, (3) the majority of the participants (>50%) had to have had a mild TBI (not a moderate or severe TBI), (4) published in a peer-reviewed publication, and (5) meeting pre-specified primary and/or secondary outcomes. Primary outcome(s): whether there was a significant change in concussion symptom severity (yes/no) based on the symptom severity checklist/scale used, whether there was a 50% reduction in headache days and/or disability; secondary outcome(s): sleep variables, cognitive complaints, depression, and anxiety. The search identified 917 individual studies. Two independent reviewers screened citations and full-text articles independently. Nineteen articles were pulled for full article review. Seven articles met the final inclusion criteria. The systematic review was registered in Prospero (CRD42017070072). RESULTS:Overall, there was vast heterogeneity across the studies, making it difficult to fully assess efficacy. The heterogeneity ranged from differences in patient populations, the timing of when the interventions were initiated, the types of intervention implemented, and the measures used to assess outcomes. Seven studies were identified as meeting final inclusion criteria, resulting in a total of 1108 adult participants ranging from 18 to 80. Sixty-nine percent were male. Of the 7 studies, 3 were focused on military staff (retired and active). Time post-injury for inclusion into the studies varied from 48 hours post-injury to more than 2 years post-injury. One of the 7 studies did not include time post-TBI in the inclusion criteria. Two studies recruited patients who had visited their emergency departments, 4 of the studies recruited subjects through outpatient referrals, and 1 study recruited patients who had been in a prior traffic accident with resulting chronic PTH directly from a headache center. Group cognitive behavioral therapy (CBT) sessions and telephonic counseling or communication were common intervention methods used in the studies, with group CBT being used in 2 of the studies and telephonic counseling being used in 3. Other intervention methods used included individual CBT, cognitive training, psychoeducation, and computer-based and/or therapist-directed cognitive rehabilitation. CONCLUSIONS:Many of the interventions offered vastly different methods of delivery of intervention and doses of intervention. Many of the negative studies were done after an extended duration post-injury (>1-year posttraumatic brain injury [TBI]). In addition, the participants were lumped together regardless of their pre-concussion comorbidities, their mechanism of injury, their symptoms, and the duration from injury to the start of the intervention. The mass heterogeneity found between the studies led to inconclusive findings. Thus, there are various considerations for the design of the intervention for future behavioral/MBI studies for PTH and concussion that must be addressed before the leading question of this review may be effectively answered.