Behavioral Research and the Double‐Blind Placebo‐Controlled Methodology: Challenges in Applying the Biomedical Standard to Behavioral Headache Research
Abstract
The randomized, double-blind, placebo-controlled experimental design has prevailed as the "gold standard" in biomedical research, intended to control potential bias in patient/group assignment, investigator allegiance, patient expectations, and nonspecific therapeutic effects. Properly executed, such designs ensure a study's internal validity and allow differential group outcomes to be attributed to the active treatment. These controlled trials generally yield more conservative outcomes than open trials and case reports and establish efficacy in pharmaceutical research. In meta-analytic reviews, studies are often assigned quality scores based in part on the degree to which they meet this scientific standard. Applying the biomedical research design standards for blinding and placebo control to clinical trials evaluating behavioral and other nonpharmacologic headache treatment nearly always is either infeasible or simply not possible. Only rarely is blinding meaningfully achievable in administration of behavioral or psychological therapies. Various "psychological placebo" control conditions have been forwarded in behavioral studies (eg, sham treatments, pseudomeditation), but these controls are incapable of emulating an inert control condition comparable to that of the pill placebo in pharmacologic research, and they are best reserved for studies examining the mechanisms whereby an intervention produces improvement. This article reviews the conceptual and procedural challenges…
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Block randomization was executed by an independent person who randomly matched codes next to participants' IDs in a participant workbook.
“by an independent to the study person, who randomly matched codes next to participants’ IDs in a participant workbook.”
From Acceptance and Commitment Therapy for Primary Headache Sufferers: A Randomized Controlled Trial of Efficacy (2021) · cites this paper as [63]
A simple within-sample randomization technique was used with participants randomized in a single block.
“a simple within-sample randomization technique was used with participants being randomized in a single block.”
From Acceptance and Commitment Therapy for Primary Headache Sufferers: A Randomized Controlled Trial of Efficacy (2021) · cites this paper as [63]
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- Authors
- Rains, J. C., & Penzien, D. B.
- Affiliations
- University of Mississippi Medical Center (US)
- Corresponding author
- Rains, Jeanetta C.
- ORCID
- Penzien, Donald B.
- Venue
- Headache: The Journal of Head and Face Pain
- Publisher
- Wiley
- Published
- 2005-05
- Volume
- 45
- Issue
- 5
- Pages
- 479-486
- ISSN
- 0017-8748 (ISSN-L)
- 1526-4610
- OpenAlex
- W1983460160
- Cited by
- 63
- References
- 0
- Citations by year
- 2025: 4 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 4 · 2020: 2 · 2018: 3 · 2017: 3 · 2016: 3 · 2015: 2 · 2014: 9 · 2013: 1 · 2012: 3
- FWCI
- 0.77
- 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
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- blinding, placebo comparison, sham treatment, internal validity
- MeSH terms
- Behavior Therapy, Double-Blind Method, Humans, Quality Assurance, Health Care, Research, Research Design, Randomized Controlled Trials as Topic, Headache Disorders
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