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Smartphone-Based Muscle Relaxation for Migraine in the Emergency Department: A Randomized Clinical Trial

Minen, Mia T; Seng, Elizabeth K; Friedman, Benjamin W; George, Alexis D; Fanning, Kristina M; Bostic, Ryan C; Powers, Scott W; Lipton, Richard B
IMPORTANCE/UNASSIGNED:The emergency department (ED) is a critical point of contact within the health care system and an opportunity to initiate nonpharmacologic migraine treatment. OBJECTIVE/UNASSIGNED:To examine whether progressive muscle relaxation (PMR) smartphone-based migraine self-management improved patient-reported outcomes for migraine compared with enhanced usual care. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:A randomized clinical trial of the smartphone application RELAXaHEAD with and without PMR. Patients aged 18 to 65 years visiting New York University Langone Health EDs for headache who met migraine criteria and self reported 4 or more migraine days per month were recruited from June 2019 to October 2021 with follow-up at 3 months. Data were analyzed from June 2022 to June 2025. INTERVENTION/UNASSIGNED:Participants in the intervention group were asked to listen to the app-based PMR for 60 days. Participants in the control group were asked to use the app as a symptom diary. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Primary outcome was change in migraine-related disability (MIDAS). Secondary outcomes were change in migraine-specific quality of life (MSQv2) and monthly headache days (MHDs). Adherence (number of days of diary use, PMR use and total minutes of PMR use over 90-day period) was measured using back-end analytics. RESULTS/UNASSIGNED:Of the 94 patients (median [IQR] age, 33 [26-45] years; 57 [82.6%] female) randomized (48 control patients and 46 PMR patients), 69 of 94 (73%) had 1 or more follow-up MIDAS scores and constituted the modified intent-to-treat population (35 control patients and 34 PMR patients). The mean (SD) change in MIDAS scores from baseline to 3 months (last observation carried forward [LOCF] used if missing 3-month follow-up data) differed between groups (PMR, 25.09 [29.64] vs control, 6.86 [59.61]; P = .01). PMR had nearly double the number of respondents improving by 5 or more MIDAS points (28 of 34 [82.4%] vs 16 of 35 [45.7%] respondents; P = .002). There was no difference in MSQv2 domains from baseline to LOCF between PMR and control (mean [SD] role function preventive domain for PMR, 16.9 [24.5] vs control, 11.3 [25.9]); emotional function domain (mean [SD] for PMR, 26.5 [26.9] vs control, 19.8 [38.5]); and role function restrictive domain (mean [SD] for PMR, 18.1 [22.7] vs control, 18.7 [26.8]). Mean (SD) change in MHDs (baseline to 3 months) did not differ between groups (PMR, 2.9 [8.0]; 23 days vs control, -1.6 [6.5]; 25 days). CONCLUSION AND RELEVANCE/UNASSIGNED:A PMR-based self-management program offered to patients with migraine after ED discharge yielded clinically significant reductions in migraine-related disability. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04281030.
PMCID:12531881
PMID: 41100087
ISSN: 2574-3805
CID: 5955092

Feasibility, acceptability, and fidelity of remote-delivered abbreviated mindfulness-based cognitive therapy interventions for patients with migraine and depressive symptoms

Seng, Elizabeth K; Hill, Jacob; Reeder, Annie Kate; Visvanathan, Pallavi; Wells, Rebecca E; Lipton, Richard B; Minen, Mia; Shallcross, Amanda J
OBJECTIVE:This study was an open-label single-arm clinical trial evaluating the fidelity, feasibility, acceptability, and clinical signal of abbreviated mindfulness-based cognitive therapy (MBCT-brief) delivered either via telephone (MBCT-T) or by video conferencing (MBCT-V) for people with migraine and comorbid depressive symptoms. BACKGROUND:Migraine is commonly comorbid with elevated depressive symptoms. MBCT reduces depressive symptoms and shows promise to reduce migraine-related disability. An abbreviated and remotely delivered version of MBCT could increase access to care. METHODS:) at baseline, mid-treatment, and post-treatment. Feasibility and acceptability rates were compared to a priori benchmarks. RESULTS:(pre-treatment median [interquartile range] score 8 [5, 13] vs. post-treatment 4 [3, 6], p = 0.003). CONCLUSION/CONCLUSIONS:We found that remotely delivered MBCT-brief for migraine and depressive symptoms was feasible and acceptable to patients in both the telephone and video modalities. Intervention was associated with significant post-treatment reductions in headache-related disability and depressive symptomatology, findings that must be interpreted cautiously in the absence of a control group.
PMID: 39400343
ISSN: 1526-4610
CID: 5718352

Behavioral interventions for migraine prevention: A systematic review and meta-analysis

Treadwell, Jonathan R; Tsou, Amy Y; Rouse, Benjamin; Ivlev, Ilya; Fricke, Julie; Buse, Dawn C; Powers, Scott W; Minen, Mia; Szperka, Christina L; Mull, Nikhil K
OBJECTIVES/BACKGROUND/OBJECTIVE:This study was undertaken to synthesize evidence on the benefits and harms of behavioral interventions for migraine prevention in children and adults. The efficacy and safety of behavioral interventions for migraine prevention have not been tested in recent systematic reviews. METHODS:An expert panel including clinical psychologists, neurologists, primary care physicians, researchers, funders, individuals with migraine, and their caregivers informed the scope and methods. We searched MEDLINE, Embase, PsycINFO, PubMed, the Cochrane Database of Systematic Reviews, clinicaltrials.gov, and gray literature for English-language randomized trials (January 1, 1975 to August 24, 2023) of behavioral interventions for preventing migraine attacks. Primary outcomes were migraine/headache frequency, migraine disability, and migraine-related quality of life. One reviewer extracted data and rated the risk of bias, and a second verified data for completeness and accuracy. Data were synthesized with meta-analysis when deemed appropriate, and we rated the strength of evidence (SOE) using established methods. RESULTS:For adults, we included 50 trials (77 publications, N = 6024 adults). Most interventions were multicomponent (e.g., cognitive behavioral therapy [CBT], biofeedback, relaxation training, mindfulness-based therapies, and/or education). Most trials were at high risk of bias, primarily due to possible measurement bias and incomplete data. For adults, we found that any of three components (CBT, relaxation training, mindfulness-based therapies) may reduce migraine/headache attack frequency (SOE: low). Education alone that targets behavior may improve migraine-related disability (SOE: low). For three other interventions (biofeedback, acceptance and commitment therapy, and hypnotherapy), evidence was insufficient to permit conclusions. We also found that mindfulness-based therapies may reduce migraine disability more than education, and relaxation + education may improve migraine-related quality of life more than propranolol (SOE: low). For children/adolescents, we included 13 trials (16 publications, N = 1444 children), but the evidence was only sufficient to conclude that CBT + biofeedback + relaxation training may reduce migraine attack frequency and disability more than education alone (SOE: low). CONCLUSION/CONCLUSIONS:Results suggest that for adults, CBT, relaxation training, and mindfulness-based therapies may each reduce the frequency of migraine/headache attacks, and education alone may reduce disability. For children/adolescents, CBT + biofeedback + relaxation training may reduce migraine attack frequency and disability more than education alone. Evidence consisted primarily of underpowered trials of multicomponent interventions compared with various types of control groups. Limitations include semantic inconsistencies in the literature since 1975, differential usage of treatment components, expectation effects for subjectively reported outcomes, incomplete data, and unclear dosing effects. Future research should enroll children and adolescents, standardize intervention components when possible to improve reproducibility, consider smart study designs and personalized therapies based on individual characteristics, use comparison groups that control for expectation, which is a known challenge in behavioral trials, enroll and retain larger samples, study emerging digital and telehealth modes of care delivery, improve the completeness of data collection, and establish or update clinical trial conduct and reporting guidelines that are appropriate for the conduct of studies of behavioral therapies.
PMCID:11951403
PMID: 39968795
ISSN: 1526-4610
CID: 5814452

The American Headache Society First Contact-Headache in Primary Care program: Current metrics, knowledge assessments, and direction for future initiatives

Minen, Mia T; Malhotra, Nisha A; Waire, Erin K; Swiderski, Hayley Z; Riggins, Nina Y; Sprouse-Blum, Adam S
OBJECTIVE:This study examines the American Headache Society First Contact-Headache in Primary Care program metrics to date in order to assess the program's reach and provide direction for future initiatives. BACKGROUND:Approximately 4 million primary care office visits annually are headache-specific encounters. Therefore, it is important that primary care providers are knowledgeable about headache management. Recognizing the need, the American Headache Society First Contact designed the comprehensive First Contact-Headache in Primary Care program with input from an advisory board comprised of a diverse group of physicians and advanced practice providers with backgrounds in family and internal medicine, pediatrics, obstetrics and gynecology, and neurology. This is the first study to assess the reach of the program and critically examine how to best meet the needs of clinicians and patients going forward. METHODS:We report descriptive statistics for the First Contact website metrics from October 2020 to June 2023 and grand rounds program data from May 2020 to December 2023. We also conducted a cross-sectional analysis of survey data from presentations conducted at two large national family medicine symposia, as well as a thematic analysis of the question: "Please indicate what areas of your practice could be enhanced or improved with additional education?" RESULTS:The First Contact program homepage was the second most visited page on the American Headache Society website (>100,000 views). A total of 20 podcast episodes were created for the program (>3500 plays). The First Contact program held 99 events (72 institutional grand rounds, 22 State-level meetings, and five national meetings), reaching >7000 clinicians. The institutional grand rounds and state-level meetings were held across 27 States and Washington D.C. Only 31.9% (30/94) of First Contact program events (excluding national meetings) occurred in the West census region, which has the fewest headache subspecialists and lowest headache subspecialist density in the United States. When examining survey data of participants who attended the two virtual national family medicine symposia (39.3% response rate, N = 636/1620), 85.7% (544/635) reported being "completely confident" or "very confident" in their ability to recognize and accurately diagnose patients presenting with a primary complaint of headache and 81.5% (517/634) reported being "completely confident" or "very confident" in their ability to develop evidence-based treatment plans that are tailored to the needs of individual patients. The use of diagnostic tools to recognize patients with migraine (60.4%, 384/636) and translating standards of care to the practice setting (42.5%, 270/636) were the most reported intended changes by participants. Most participants reported that program content was of clinical relevance and would improve their patients' outcomes (90.5% [571/631] and 90.6% [572/631], respectively). Over three-quarters (77.8%, 495/636) of participants reported areas of their practice that can be improved by additional education specifically regarding workflow, diagnosis, and management. CONCLUSION/CONCLUSIONS:This study evaluates one of the first national initiatives for primary care education. Data from the two First Contact Family Medicine national symposia indicate the program is generally well received with most participants reporting improved confidence and intention to implement key changes in practice to improve care for patients with headache; however, there remain areas of exploration for education that could further enhance participant experience and expand the reach of the initiatives. Areas for future programming include continued education on multifactorial approaches to headache treatment and suggestions for addressing cost, insurance, and time constraints. Also, future work may examine where the First Contact program might focus initiatives based on specific areas of need in headache care, such as geographic "desert" areas, racial and ethnic disparities, and uninsured/underinsured populations.
PMID: 39501725
ISSN: 1526-4610
CID: 5783442

Headache diagnosis and treatment: A pilot knowledge and needs assessment among physical therapists

Minen, Mia T; Whetten, Christopher; Messier, Danielle; Mehta, Sheena; Williamson, Anne; Verhaak, Allison; Grosberg, Brian
OBJECTIVE:The objective of this pilot study was to assess physical therapists' (PTs) knowledge and needs regarding headache diagnosis and management. BACKGROUND:While there is significant research on physical therapy and cervicogenic headache, studies suggest that migraine is often under-recognized, misdiagnosed, and inadequately treated across society despite its high prevalence and burden. Because migraine commonly includes concurrent neck pain and/or vestibular symptoms, patients with migraine may present to PTs for treatment. Very little is known about PTs' headache and migraine education, knowledge, and clinical practices. METHODS:A team of headache specialists and PTs adapted a previously used headache knowledge and needs assessment survey to help ascertain PTs' knowledge and needs regarding headache treatment. The cross-sectional survey was distributed online via Research Electronic Data Capture (REDCap) to PTs within a large healthcare system in Connecticut. RESULTS:An estimated 50.5% (101/200) of PTs invited to complete the survey did so. Only 37.6% (38/101) of respondents reported receiving any formal headache or migraine education in their professional training, leading to knowledge gaps in differentiating and responding to headache subtypes. Only 45.5% (46/101) were able to identify that migraine is characterized by greater pain intensity than tension-type headache, and 22.8% (23/101) reported not knowing the duration of untreated migraine. When asked about the aspects of care they believe their patients with headache would like to see improved, PTs reported education around prevention and appropriate medication use (61/100 [61.0%]), provider awareness of the degree of disability associated with migraine (51/100 [51.0%]), and diagnostics (47/100 [47.0%]). CONCLUSION/CONCLUSIONS:This sample of PTs from one healthcare system demonstrates knowledge gaps and variations in clinical practice for managing their patients with headache. Future research on integrating additional opportunities for headache education for physical therapists, including evidence-based behavioral therapies, is needed to ascertain whether it is likely to improve patient care.
PMID: 39228263
ISSN: 1526-4610
CID: 5687882

Artificial intelligence terminology, methodology, and critical appraisal: A primer for headache clinicians and researchers

Dumkrieger, Gina M; Chiang, Chia-Chun; Zhang, Pengfei; Minen, Mia T; Cohen, Fred; Hranilovich, Jennifer A
OBJECTIVE:The goal is to provide an overview of artificial intelligence (AI) and machine learning (ML) methodology and appraisal tailored to clinicians and researchers in the headache field to facilitate interdisciplinary communications and research. BACKGROUND:The application of AI to the study of headache and other healthcare challenges is growing rapidly. It is critical that these findings be accurately interpreted by headache specialists, but this can be difficult for non-AI specialists. METHODS:This paper is a narrative review of the fundamentals required to understand ML/AI headache research. Using guidance from key leaders in the field of headache medicine and AI, important references were reviewed and cited to provide a comprehensive overview of the terminology, methodology, applications, pitfalls, and bias of AI. RESULTS:We review how AI models are created, common model types, methods for evaluation, and examples of their application to headache medicine. We also highlight potential pitfalls relevant when consuming AI research, and discuss ethical issues of bias, privacy and abuse generated by AI. Additionally, we highlight recent related research from across headache-related applications. CONCLUSION/CONCLUSIONS:Many promising current and future applications of ML and AI exist in the field of headache medicine. Understanding the fundamentals of AI will allow readers to understand and critically appraise AI-related research findings in their proper context. This paper will increase the reader's comfort in consuming AI/ML-based research and will prepare them to think critically about related research developments.
PMID: 39658951
ISSN: 1526-4610
CID: 5762622

Mechanisms for mindfulness in migraine: Does catastrophizing matter? [Editorial]

Wells, Rebecca Erwin; O'Connell, Nathaniel; Minen, Mia T
PMID: 38842246
ISSN: 1526-4610
CID: 5665582

Factors Associated with Patient Adherence to Biofeedback Therapy Referral for Migraine: An Observational Study

Minen, Mia T; George, Alexis; Cuneo, Ami Z
Biofeedback has Grade A evidence for the treatment of migraine, yet few studies have examined the factors associated with patients' decisions to pursue biofeedback treatment recommendations. We sought to examine reasons for adherence or non-adherence to referral to biofeedback therapy as treatment for migraine. Patients with migraine who had been referred for biofeedback by a headache specialist/behavioral neurologist were interviewed in person or via Webex. Patients completed an enrollment questionnaire addressing demographics and questions related to their headache histories. At one month, patients were sent a follow-up questionnaire via REDCap and asked if they had pursued the recommendation for biofeedback therapy, their reasons for their decision, and their impressions about biofeedback for those who pursued it. Nearly two-thirds (65%; 33/51) of patients responded at one month. Of these, fewer than half (45%, 15/33) had contacted biofeedback providers, and only 18% (6/33) completed a biofeedback session. Common themes emerged for patients who did not pursue biofeedback, including feeling that they did not have time, concern for financial obstacles (e.g., treatment cost and/or insurance coverage), and having difficulty scheduling an appointment due to limited provider availability. When asked about their preference between type of biofeedback provider (e.g., a physical therapist or psychologist), qualitative responses were mixed; many patients indicated no preference as long as they took insurance and/or were experienced, while others indicated a specific preference for a physical therapist or psychologist due to familiarity, or prior experiences with that kind of provider. Patients with migraine referred for biofeedback therapy face numerous obstacles to pursuing treatment.
PMID: 38386246
ISSN: 1573-3270
CID: 5634452

Treatment Options for Posttraumatic Headache: A Current Review of the Literature

Minen, Mia T; Mahmood, Naoroz; Khan, Fardin; Waire, Erin K; George, Alexis; Datta, Shae
PURPOSE OF REVIEW/OBJECTIVE:We evaluate evidence-based treatments for posttraumatic headache (PTH), a secondary headache disorder resulting from traumatic brain injury (TBI), comprising nearly 4% of all symptomatic headache disorders. Utilizing recent publications, we aim to inform clinicians of current treatment methods. RECENT FINDINGS/RESULTS:There is limited research on PTH treatment. A randomized controlled trial (RCT) of metoclopramide with diphenhydramine for acute PTH found that the treatment group (N = 81) experienced more significant pain improvement than placebo by 1.4 points. For persistent PTH, an open-label study of erenumab (N = 89) found that 28% of participants reported ≥ 50% reduction in moderate-to-severe headache days, but an RCT of fremanezumab showed a non-significant reduction in moderate-to-severe headache days. A randomized crossover study of 40 patients with persistent PTH found that onabotulinum toxin-A decreased cumulative number of headaches/week by 43.3% in the treatment group and increased by 35.1% among placebos. In a study of military veterans with severe posttraumatic stress disorder and persistent/delayed onset PTH (N = 193), patients who received Cognitive Behavioral Therapy reported significant improvements in headache-related disability compared to usual care (aggregate mean HIT-6, -3.4). A transcranial magnetic stimulation (N = 24) study found that 58% of participants with mild TBI-related headache experienced a 50% reduction in headache frequency. New studies indicate promise in improving clinically important outcomes of PTH. However, more research is necessary to determine the optimal treatment and whether combining pharmacologic and nonpharmacologic treatment versus a single modality is more effective.
PMID: 38133705
ISSN: 1534-3081
CID: 5612262

A Comparison of Patients' and Neurologists' Assessments of their Teleneurology Encounter: A Cross-Sectional Analysis

Thawani, Sujata P; Minen, Mia T; Grossman, Scott N; Friedman, Steven; Bhatt, Jaydeep M; Foo, Farng-Yang A; Torres, Daniel M; Weinberg, Harold J; Kim, Nina H; Levitan, Valeriya; Cardiel, Myrna I; Zakin, Elina; Conway, Jenna M; Kurzweil, Arielle M; Hasanaj, Lisena; Stainman, Rebecca S; Seixas, Azizi; Galetta, Steven L; Balcer, Laura J; Busis, Neil A
PMID: 37624656
ISSN: 1556-3669
CID: 5599032