Abstract
Objective: The aim of this study was to conduct a pilot, randomized controlled trial (RCT) of acceptance-commitment therapy (ACT) among women with episodic migraine, aged 18-65 years, and living in the United States. Background: Biobehavioral treatments have recently been proposed as possible preventive therapies for migraine management. ACT is a third wave biobehavioral therapy focused on acceptance and development of psychological flexibility and is evidence based for use in other chronic pain conditions. However, its use for reducing migraine frequency and disability has been understudied to date. Methods: The authors performed a pilot RCT evaluating ACT versus enhanced usual care (EUC) among adult women with episodic migraine. ACT consisted of eight virtual weekly sessions (for 8 weeks). Primary aims evaluated feasibility, retention, and protocol adherence. Secondary clinical outcomes included changes in migraine days and Migraine Disability Assessment (MIDAS). Results: We were able to successfully recruit 54 women in 15 months, which surpassed our recruitment goal. However, the completion rates of migraine logs and questionnaires at both outcome assessments were lower than anticipated. Among the 17 individuals randomized to EUC, 12 (71%) completed migraine logs and 12 (71%) completed questionnaires at the end of the intervention. In the postintervention follow-up, 11 (65%) individuals completed logs and 11 (65%) completed questionnaires. We observed slightly larger decreases in migraine days for those assigned to ACT from baseline to the end of the intervention, but these differences did not persist during postintervention follow-up. Both groups reported similar decreases in MIDAS over time. Conclusions: Recruitment for a large-scale trial of ACT is feasible. Challenges with remote data collection as well as participant burden during the COVID-19 pandemic resulted in lower than anticipated completion rates. Future studies should focus on decreasing participant burden and streamlining study procedures. Clinical Trials Registration: NCT05003362.