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The dilemma of the control condition in experience-based cognitive and behavioural treatment research
Abstract
Rehabilitation using cognitive and behavioural treatment methods (i.e., experience-based interventions) faces particular challenges in improving its evidence base through rigorous studies such as randomised controlled trials (RCTs). Experience-based treatments are often complex, with multiple "active ingredients" that may be difficult to characterise. In addition to the difficulty in specifying treatment ingredients, experience-based rehabilitation researchers face challenges in designing or selecting appropriate control or comparison conditions to test the efficacy of complex treatments. Based on lessons learned in designing a cognitive-behavioural intervention for anger self-management for people with traumatic brain injury (TBI) for the National Institutes of Health (NIH)-funded TBI Clinical Trials Network, we review the advantages, disadvantages and applications of a variety of control conditions for experience-based interventions. We discuss controls in which active treatments are withheld (no-treatment controls, waitlist controls, and placebo-analogue designs); controls that involve comparison to naturally occurring or devised usual care treatments; and conditions that compare active treatments (dismantling designs, dose controls, and equivalence trials). Recommendations for selecting and developing control groups that maximise both equipoise and participant enrolment/retention are discussed.
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“There is a growing discussion over the use of waitlist in psychological and behavioral research [83].”
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Metadata
- Authors
- Hart, T., Fann, J. R., & Novack, T. A.
- Affiliations
- Thomas Jefferson University (US)
- University of Washington (US)
- University of Alabama at Birmingham (US)
- Corresponding author
- Hart, Tessa
- Venue
- Neuropsychological Rehabilitation
- Publisher
- Informa UK Limited
- Published
- 2008-01
- Volume
- 18
- Issue
- 1
- Pages
- 1-21
- ISSN
- 0960-2011 (ISSN-L)
- 1464-0694
- OpenAlex
- W2019260073
- Cited by
- 140
- References
- 39
- Citations by year
- 2025: 2 · 2024: 11 · 2023: 9 · 2022: 9 · 2021: 10 · 2020: 16 · 2019: 8 · 2018: 6 · 2017: 8 · 2016: 9 · 2015: 7 · 2014: 5 · 2013: 12 · 2012: 5
- FWCI
- 6.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neuropsychological Rehabilitation (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01HD042738, R24HD050836)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Clinical Neurology › Traumatic Brain Injury Research
- Keywords
- control conditions, traumatic brain injury, randomized controlled trials, waitlist control, equivalence trials, equipoise, participant retention
- MeSH terms
- Anger, Behavior Therapy, Brain Injuries, Humans, Randomized Controlled Trials as Topic, Evidence-Based Medicine, Therapeutic Human Experimentation
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