Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group
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This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions.
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An active control condition instead of treatment as usual was chosen to control for non-specific attention and self-monitoring effects.
“An active control condition instead of treatment as usual was chosen to control for non-specific attention and self-monitoring effects [27].”
From Online prenatal trial in mindfulness sleep management (OPTIMISM): Protocol for a pilot randomized controlled trial (2020) · cites this paper as [27]
The Introduction and Discussion explain that care-as-usual controls often fail to account for nonspecific effects, and Methods > Intervention Development says the education-only control accounted for therapist attention. But that section says control participants kept no weekly behavioral logs, so it does not support the claim that the active control accounted for self-monitoring effects. Our copy provides no page numbers for these passages. (LLM, conf=0.87)
Experimental — accuracy not yet measuredParticipants will know that the research study is testing two alternative online interventions to improve sleep in pregnancy but will not be informed of the nature of the two interventions. This reduces the likelihood of EOC participants seeking out mindfulness treatments independently, or dropping prematurely because of disappointment over being assigned to a control group.
“Participants will know that the research study is testing two alternative online interventions to improve sleep in pregnancy but will not be informed of the nature of the two interventions. This reduces the likelihood of EOC participants seeking out mindfulness treatments independently, or dropping prematurely because of disappointment over being assigned to a control group [27].”
From Online prenatal trial in mindfulness sleep management (OPTIMISM): Protocol for a pilot randomized controlled trial (2020) · cites this paper as [27]
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Experimental — accuracy not yet measuredStrengths of this study include provision of an active control treatment based on sleep education tailored to pregnancy.
“Strengths of this study include provision of an active control treatment based on sleep education [27] tailored to pregnancy.”
From Online prenatal trial in mindfulness sleep management (OPTIMISM): Protocol for a pilot randomized controlled trial (2020) · cites this paper as [27]
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- Authors
- Balderson, B. H., McCurry, S. M., Vitiello, M. V., Shortreed, S. M., Rybarczyk, B. D., Keefe, F. J., & Korff, M. V.
- Affiliations
- Kaiser Permanente Washington Health Research Institute (US)
- University of Washington (US)
- Virginia Commonwealth University (US)
- Duke Medical Center (US)
- Corresponding author
- Balderson, Benjamin H.
- ORCID
- Venue
- Behavioral Sleep Medicine
- Publisher
- Informa UK Limited
- Published
- 2015-10-20
- Volume
- 14
- Issue
- 5
- Pages
- 514-527
- ISSN
- 1540-2002 (ISSN-L)
- 1540-2010
- PMC
- PMC4838558
- OpenAlex
- W1794328166
- Semantic Scholar
- 09cd8d91fa822351dabc6d43b44b97cbd7ca90b2
- Cited by
- 16
- References
- 41
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 3 · 2020: 1 · 2019: 1 · 2017: 1 · 2016: 1
- FWCI
- 0.59
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Behavioral Sleep Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (R01-AG031126)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- control group design, randomized controlled trials, behavioral interventions, cognitive behavioral therapy, osteoarthritis pain, insomnia
- MeSH terms
- Aged, Double-Blind Method, Female, Humans, Sleep Initiation and Maintenance Disorders, Longitudinal Studies, Male, Cognitive Behavioral Therapy, Treatment Outcome, Control Groups
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