Cited by 135Migraine and Headache StudiesTemporomandibular Joint DisordersStatistical Methods in Clinical Trials

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

Penzien, Donald B., Andrasik, Frank, Freidenberg, Brian M., Houle, Timothy T., Lake, Alvin E., Lipchik, Gay L., Holroyd, Kenneth A., Lipton, Richard B. +6 more·2005·Headache: The Journal of Head and Face Pain

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.

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Crossref · 10.1111/j.1526-4610.2005.4502004.x

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Authors
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.
Affiliations
University of Mississippi (US)
Venue
Headache: The Journal of Head and Face Pain
Publisher
Wiley
Published
2005-05
Volume
45
Issue
s2
Pages
S110-32
ISSN
  • 0017-8748 (ISSN-L)
  • 1526-4610
OpenAlex
W2142405574
Cited by
135
References
100
Citations by year
2026: 2 · 2025: 1 · 2024: 3 · 2023: 5 · 2022: 3 · 2021: 3 · 2020: 5 · 2019: 11 · 2018: 6 · 2017: 6 · 2016: 18 · 2015: 11 · 2014: 12 · 2013: 10 · 2012: 5
FWCI
5.00
Type
journal article
Language
en
Open access
closed
Locations
  • Headache The Journal of Head and Face Pain (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Migraine and Headache Studies
  • Health Sciences › Health Professions › Complementary and Manual Therapy › Temporomandibular Joint Disorders
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
recurrent headache, clinical trial design, primary headache, non-pharmacological treatment, patient selection, research ethics
MeSH terms
Behavior Therapy, Clinical Trials as Topic, Humans, Recurrence, Research Design, Outcome Assessment, Health Care, Patient Selection, Headache Disorders

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