Efficacy of a Single-Session Telehealth-Based Behavioral Intervention for Chronic Migraines

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Abstract The overall goal of the current K23 project is to support Dr. John Sturgeon’s career development as a clinical researcher in chronic migraine populations; specific training aims are to expand his training in the areas of clinical trial design and development, medical and neurological bases of migraine headaches, and the analysis of time- series, hierarchical, and clinical trials data. Migraine is among the most common medical conditions in the United States and contribute to substantial work loss, economic burden, and psychosocial disability. Strikingly, people with chronic migraine (CM) show even greater symptom severity, disability and poorer psychosocial adjustment to their condition across studies, compared to those with episodic migraine. Effective treatment of CM necessitates an interdisciplinary approach that emphasizes both medical and non-medical interventions to address the complex pattern of disability and psychosocial impairment in this population. Behavioral interventions such as cognitive-behavioral therapy and mindfulness meditation have demonstrated efficacy in reducing migraine frequency, severity, and disability. However, access to these treatments is poor, particularly among individuals not receiving care through specialty clinics. Further, many patients are unable to afford either the financial or time costs associated with traditional behavioral interventions, which typically necessitate weekly sessions for 2-3 months. Consequently, there is a compelling need to utilize develop brief, accessible, and empirically validated interventions to improve the quality of CM management nationwide. Aim 1 of the study proposes to conduct a randomized trial to test the efficacy of a novel, 2-hour single-session behavioral intervention (“Empowered Relief”; ER) against a health education condition in individuals with CM. Aim 2 of the study proposes to examine the dynamics of migraine activity, migraine-related disability, medication use, and indicators of psychological adjustment using daily diary data, an assessment method that is both common in CM management and desirable for comprehensive statistical modeling. The ER intervention has been validated in both mixed chronic pain and chronic low back pain samples but, to date, has not been validated in migraine populations. If successful, the current project will form the basis of a future randomized clinical trial comparing the potential non-inferiority of the ER intervention against traditional, full-length behavioral interventions for CM. The specific training experiences in this K23 project form an excellent complement to Dr. Sturgeon’s existing training as a clinical pain psychologist and analytically-oriented chronic pain researcher. The current project provides a comprehensive 5-year plan encompassing high-quality mentorship, training, and research to transition Dr. Sturgeon, to the role of an independently funded researcher with the potential to make a significant impact in the field of migraine treatment and behavioral clinical trials.