Guidelines for trials of behavioral treatments for recurrent headache: purpose, process, and product.

The behavioral clinical trials guidelines presented in this supplement1 were developed to enhance the quality and consistency of research evaluating behavioral treatments for primary headache disorders. Developed under the auspices of the American Headache Society (AHS), these guidelines are complementary to and modeled after guidelines published by the International Headache Society to address research methodology apropos to drug trials for migraine,2 tension-type headache,3 and cluster headache.4 Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research.