Donald B. Penzien, PhD; Frank Andrasik, PhD; Brian M. Freidenberg, PhD; Timothy T. Houle, PhD; Alvin E. Lake, III, PhD; Gay L. Lipchik, PhD; Kenneth A. Holroyd, PhD; Richard B. Lipton, MD; Douglas C. McCrory, MD; Justin M. Nash, PhD; Robert A. Nicholson, PhD; Scott W. Powers, PhD, ABPP; Jeanetta C. Rains, PhD; David A. Wittrock, PhD
Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. 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. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.
(Headache 2005;45[Suppl 2]:S110-S132)