Purpose of Review Behavioral therapies are proven treatments for many neurologic conditions. However, the COVID-19 pandemic has posed significant challenges for conducting behavioral research. This article aims to (1) highlight the challenges of running behavioral clinical trials during the pandemic, (2) suggest approaches to maximize generalizability of pandemic-era studies, and (3) offer strategies for successful behavioral trials beyond the pandemic. Recent Findings Thousands of clinical trials have been impacted by the COVID-19 pandemic, from undergoing protocol revisions to suspension altogether. Furthermore, for ongoing trials, recruitment of diverse populations has suffered, thereby exacerbating existing inequities in clinical research. Patient adherence and retention have been affected by a myriad of pandemic-era restraints, and medical, psychiatric, and other complications from the pandemic have the potential to have long-term effects on pandemic-era study results. Summary In the development of post-pandemic study protocols, attention should be given to designing studies that incorporate successful aspects of pre-pandemic and pandemic-era strategies to (1) broaden recruitment using new techniques, (2) improve access for diverse populations, (3) expand protocols to include virtual and in-person participation, and (4) increase patient adherence and retention.
Objectives: To determine if the frequent use of a combined biofeedback-virtual reality device improves headache-related outcomes in chronic migraine. Materials and Methods:In this randomized, controlled pilot study, 50 adults with chronic migraine were randomized to the experimental group (frequent use of a heart rate variability biofeedback-virtual reality device plus standard medical care; n = 25) or wait-list control group (standard medical care alone; n = 25). The primary outcome was a reduction in mean monthly headache days between groups at 12 weeks. Secondary outcomes included mean change in acute analgesic use frequency, depression, migraine-related disability, stress, insomnia, and catastrophizing between groups at 12 weeks. Tertiary outcomes included change in heart rate variability and device-related user experience measures.Results: A statistically significant reduction in mean monthly headache days between groups was not demonstrated at 12 weeks. However, statistically significant decreases in the mean frequency of total acute analgesic use per month (65% decrease in the experimental group versus 35% decrease in the control group, P < 0.01) and depression score (35% decrease in the experimental group versus 0.5% increase in the control group; P < 0.05) were shown at 12 weeks. At study completion, more than 50% of participants reported device satisfaction on a 5-level Likert scale.Discussion: Frequent use of a portable biofeedback-virtual reality device was associated with decreases in the frequency of acute analgesic use and in depression in individuals with chronic migraine. This platform holds promise as an add-on treatment for chronic migraine, especially for individuals aiming to decrease acute analgesic use or interested in nonmedication approaches.
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