Although this pilot study suggests that the MBSR intervention may have clinically meaningful benefits, our results demonstrate the need for larger studies with an active control group, longer follow-up periods, and the collection of additional information to determine the mechanism of any effects. The biological mechanism for any potential efficacy is unknown, and this study demonstrates the need for further research in this area. MBSR may work by changing how migraineurs interpret pain, or may work through a therapeutic effect on other factors playing a role in headaches, such as improved emotion regulation, less pain catastrophizing, and increased pain acceptance. As an illustration, the MBSR instructor in this trial noted that many of the participants commented that, "I'm still having migraines, but I don't react to them as much, and am to be able to continue in my normal routine." Headaches are often considered to be a physical disorder influenced by psychosocial and environmental stressors, so mind/body treatments such as MBSR may address these other factors playing a role in headaches. However, these processes are poorly understood and need further study.
Conflict of Interest
Timothy T. Houle: Dr. Houle receives research support from GlaxoSmithKline, Merck, and Depomed. All other authors report no conflicts of interest.
This clinical trial was registered 24 February 2012: clinicaltrials.gov identifier NCT01545466.
This study was supported financially by the American Headache Society Fellowship (RW and RB) and the Headache Research Fund of the John Graham Headache Center, Brigham and Women's Faulkner Hospital. We thank Dr. James C. Eisenach at Wake Forest School of Medicine for his help with this project. We thank Drs. Paul Mathew, Luzma Cardona, Paul Rizzoli, Don Levy, Rebecca Burch, Megan Tabor, William Mullally, and Thomas Walshe, III for referring patients to this study. We thank Lynn Simpson of BWH Harvard Catalyst REDCap support, Harvard Catalyst research assistant Peter Douglass, and Harvard Catalyst biostatistician Roger Davis, ScD, for their help with aspects of this study. We thank the Osher Center for Integrative Medicine at Brigham and Women's Hospital for their support of this project, specifically in providing the clinical space for patient evaluations and for the MBSR classes. We appreciate the statistical support from Carol Aschenbrenner and the editing support from Karen Klein, both at Wake Forest School of Medicine.
Headache. 2014;54(9):1484-1495. © 2014 Blackwell Publishing