Can attention control conditions have detrimental effects on behavioral medicine randomized trials?
Open accessAbstract
OBJECTIVE: Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental. METHODS: Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet. RESULTS: At 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC. CONCLUSIONS: AC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00217919.
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Attention control conditions can have unintended detrimental effects.
“We considered an alternative comparison condition to control for attention, but it would not reflect current clinical realities and attention control conditions can have unintended detrimental effects [26 -28].”
From Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue (2023) · cites this paper as [28]
Pairwise meta-analysis assumes that all control groups are the same, which is not always the case.
“Pairwise meta-analysis also assumes that all control groups are the same, which is not always the case 18 .”
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- Authors
- Pagoto, S. L., McDermott, M. M., Reed, G., Greenland, P., Mazor, K. M., Ockene, J. K., Whited, M., Schneider, K., Appelhans, B., Leung, K., Merriam, P., & Ockene, I.
- Affiliations
- University of Massachusetts Chan Medical School (US)
- Northwestern University (US)
- Corresponding author
- Pagoto, Sherry L.
- Venue
- Psychosomatic Medicine
- Published
- 2013-02
- Volume
- 75
- Issue
- 2
- Pages
- 137-143
- ISSN
- 0033-3174 (ISSN-L)
- PMC
- PMC3570637
- OpenAlex
- W2076871327
- Cited by
- 35
- References
- 30
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 4 · 2023: 3 · 2022: 5 · 2021: 3 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 3 · 2014: 1 · 2013: 1
- FWCI
- 0.61
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Psychosomatic Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- The Journal of the American Medical Association (JAMA) Network (American Medical Association) (submittedVersion)
- Funders
- National Institutes of Health (UL1TR000150)
- National Heart, Lung, and Blood Institute (K23HL109620, R01HL073912)
- National Center for Advancing Translational Sciences
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- behavioral interventions, randomized controlled trials, patient-centered counseling, peripheral arterial disease, LDL cholesterol, lipid-lowering drugs, medication adherence, dose intensity, usual care, educational pamphlets
- MeSH terms
- Aged, Analysis of Variance, Anticholesteremic Agents, Attention, Behavioral Medicine, Counseling, Dietary Fats, Female, Humans, Health Knowledge, Attitudes, Practice, Cholesterol, LDL, Male, Patient Education as Topic, Professional-Patient Relations, Telephone, Randomized Controlled Trials as Topic, Treatment Outcome, Self Efficacy, Control Groups, Medication Adherence, Peripheral Arterial Disease, Anticipation, Psychological
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