Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup


  • 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

Address all coresspondence to Dr. Donald B. Penzien, Professor and Director, Head Pain Center, Department of Psychiatry and Human Behavior University of Mississippi Medical Center 2500 North State Street, Jackson, MS 39216.


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.