Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society behavioral clinical trials workgroup

Donald B. Penzien, Frank Andrasik, Brian M. Freidenberg, Timothy T. Houle, Alvin E. Lake, Gay L. Lipchik, Kenneth A. Holroyd, Richard B. Lipton, Douglas C. McCrory, Justin M. Nash, Robert A. Nicholson, Scott W. Powers, Jeanetta C. Rains, David A. Wittrock

Research output: Contribution to journalReview article

92 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)S110-S132
JournalHeadache
Volume45
Issue numberSUPPL. 2
DOIs
StatePublished - May 2005
Externally publishedYes

Keywords

  • Behavioral
  • Biofeedback
  • Cognitive-behavioral therapy
  • Control group
  • Design
  • Guideline
  • Headache
  • Methodology
  • Migraine
  • Relaxation
  • Stress-management training
  • Trials

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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    Penzien, D. B., Andrasik, F., Freidenberg, B. M., Houle, T. T., Lake, A. E., Lipchik, G. L., Holroyd, K. A., Lipton, R. B., McCrory, D. C., Nash, J. M., Nicholson, R. A., Powers, S. W., Rains, J. C., & Wittrock, D. A. (2005). Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society behavioral clinical trials workgroup. Headache, 45(SUPPL. 2), S110-S132. https://doi.org/10.1111/j.1526-4610.2005.4502004.x