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Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup
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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“a daily self-report headache diary built according to the guidelines provided by Penzien et al. [32] for trials of behavioral treatments for headache and according to the guidelines provided by Tfelt-Hansen et al. [36] for controlled trials of drugs in migraine treatment”
From Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial. (2018) · cites this paper as [32]
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Metadata
- 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)
- ORCID
- 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 › Clinical Neurology › Migraine and Headache Studies
- Health Sciences › Dentistry › Oral Surgery › 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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