Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure

Friedberg, Jennifer P.; Lipsitz, Stuart R.; Natarajan, Sundar

doi:10.1016/j.pec.2009.04.009

Cited by 82Statistical Methods in Clinical TrialsHealth Policy Implementation ScienceAdvanced Causal Inference Techniques

Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure

Friedberg, Jennifer P., Lipsitz, Stuart R., Natarajan, Sundar·2010·Patient Education and Counseling

DOI 10.1016/j.pec.2009.04.009

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Abstract

Objective To describe the challenges to blinding in behavioral interventions, specifically those for asymptomatic medical conditions, where the intervention is through counseling, and to provide recommendations for achieving blinding in behavioral randomized controlled trials (RCTs).Methods This paper reviews the challenges of preserving blinding in behavioral RCTs with a focus on interventions for asymptomatic medical conditions. This is illustrated using a case study of an ongoing behavioral intervention to improve hypertension control.Results In contrast to easily keeping study investigators and participants masked to treatment assignment through the use of identical pills or sham treatments, the need to have differing levels of blinding among study personnel and participants in randomized behavioral intervention trials is presented. Recommendations for achieving this are provided.Conclusions Despite the challenges inherent in behavioral interventions, it is possible to achieve differing levels of blinding across study personnel and participants to minimize bias and generate valid data in RCTs that test interventions for asymptomatic medical conditions such as hypertension. Modifications may be needed for RCTs in symptomatic medical conditions.Practice implications Researchers designing behavioral RCTs should be aware of the challenges to blinding all staff and study participants, and plan to have procedures in place to standardize outcome data collection and intervention delivery without compromising the varying levels of blinding. The challenges and recommendations described may need modifications in behavioral intervention studies for symptomatic conditions.

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Approaches to managing communication within the team overlap with those reported in previous studies.
“These approaches overlap with those reported in previous studies [8, 14, 18, 19, 23] and reflect the many considerations required to ensure blinding of outcome assessors.”
From Blinding outcome assessors in randomised controlled trials of psychological interventions: how is it done? A narrative review (2026) · cites this paper as [18]
Asking participants not to discuss their treatment to avoid unblinding is a method frequently reported in the existing literature.
“The most common method reported was avoiding unblinding by participants through asking them not to discuss their treatment, a method frequently reported in the existing literature [5, 14, 18, 23].”
From Blinding outcome assessors in randomised controlled trials of psychological interventions: how is it done? A narrative review (2026) · cites this paper as [18]

Untitled work
(1963) · Medical Entomology and Zoology · Cited by 15,085 · see citing works
Stages and processes of self-change of smoking: Toward an integrative model of change.
Prochaska, J. O., & DiClemente, C. C. (1983) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.51.3.390 · Cited by 9,098 · see citing works
A Multiple Testing Procedure for Clinical Trials
O'Brien, P. C., & Fleming, T. R. (1979) · Biometrics · doi:10.2307/2530245 · Cited by 3,311 · see citing works
Enhancing Treatment Fidelity in Health Behavior Change Studies: Best Practices and Recommendations From the NIH Behavior Change Consortium.
Bellg, A. J., Treatment Fidelity Workgroup of the NIH Behavior Change Consortium, Borrelli, B., Resnick, B., Hecht, J., Minicucci, D. S., Ory, M., Ogedegbe, G., Orwig, D., Ernst, D., et al. (2004) · Health Psychology · doi:10.1037/0278-6133.23.5.443 · Cited by 2,620 · see citing works
Equipoise and the Ethics of Clinical Research
Freedman, B. (1987) · New England Journal of Medicine · doi:10.1056/nejm198707163170304 · Cited by 2,339 · see citing works
Discrete sequential boundaries for clinical trials
GORDON LAN, K. K., & DEMETS, D. L. (1983) · Biometrika · doi:10.1093/biomet/70.3.659 · Cited by 2,310 · see citing works
Discrete Sequential Boundaries for Clinical Trials
Lan, K. K. G., & DeMets, D. L. (1983) · Biometrika · doi:10.2307/2336502 · Cited by 2,310 · see citing works
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015) · doi:10.1007/978-3-319-18539-2 · Cited by 2,237 · see citing works
Empirical evidence of design-related bias in studies of diagnostic tests.
Lijmer, J. G. (1999) · JAMA · doi:10.1001/jama.282.11.1061 · Cited by 1,861 · see citing works
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., & DeMets, D. L. (1998) · doi:10.1007/978-1-4757-2915-3 · Cited by 873 · see citing works
Assessing the Quality of Randomization From Reports of Controlled Trials Published in Obstetrics and Gynecology Journals
Schulz, K. F. (1994) · JAMA · doi:10.1001/jama.1994.03520020051014 · Cited by 514 · see citing works
Statistics Notes: Blinding in clinical trials and other studies
Day, S. J. (2000) · BMJ · doi:10.1136/bmj.321.7259.504 · Cited by 487 · see citing works
Bias as a threat to the validity of cancer molecular-marker research
Ransohoff, D. F. (2005) · Nature reviews. Cancer · doi:10.1038/nrc1550 · Cited by 480 · see citing works
Characteristic and incidental (placebo) effects in complex interventions such as acupuncture
Paterson, C., & Dieppe, P. A. (2005) · BMJ · doi:10.1136/bmj.330.7501.1202 · Cited by 478 · see citing works
Evidence-based behavioral medicine: What is it and how do we achieve it?
Davidson, K. W., Goldstein, M. G., Kaplan, R. M., Kaufmann, P. G., Knatterud, G. L., Orleans, C. T., Spring, B. J., Trudeau, K. J., & Whitlock, E. P. (2003) · Annals of Behavioral Medicine · doi:10.1207/s15324796abm2603_01 · Cited by 407 · see citing works
Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
Boutron, I., Guittet, L., Estellat, C., Moher, D., Hróbjartsson, A., & Ravaud, P. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040061 · Cited by 389 · see citing works
CLINICIANS' EXPECTATIONS INFLUENCE PLACEBO ANALGESIA
Gracely, R. H., Dubner, R. A., Deeter, W. R., & Wolskee, P. J. (1985) · The Lancet · doi:10.1016/s0140-6736(85)90984-5 · Cited by 311 · see citing works
A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus
BOUTRON, I., MOHER, D., TUGWELL, P., GIRAUDEAU, B., POIRAUDEAU, S., NIZARD, R., & RAVAUD, P. (2005) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2005.05.004 · Cited by 308 · see citing works
Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
Boutron, I., Tubach, F., Giraudeau, B., & Ravaud, P. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2003.12.010 · Cited by 300 · see citing works
Design and Analysis of Group Sequential Tests Based on the Type I Error Spending Rate Function
Kim, K., & DeMets, D. L. (1987) · Biometrika · doi:10.1093/biomet/74.1.149 · Cited by 295 · see citing works
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Weymiller, A. (2007) · Archives of Internal Medicine · doi:10.1001/archinte.167.10.1076 · Cited by 278 · see citing works
Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD): Study design and methods
The ENRICHD investigators (2000) · American Heart Journal · doi:10.1016/s0002-8703(00)90301-6 · Cited by 255 · see citing works
The Landscape and Lexicon of Blinding in Randomized Trials
Schulz, K. F., Chalmers, I., & Altman, D. G. (2002) · Annals of Internal Medicine · doi:10.7326/0003-4819-136-3-200202050-00022 · Cited by 242 · see citing works
VIRAL HEPATITIS AND CIRRHOSIS
Sepaha, G. C., Chatterji, A. N., Khandekar, J. D., & Mukerji, D. P. (1972) · The Lancet · doi:10.1016/s0140-6736(72)90037-2 · Cited by 197 · see citing works
Clients' expectancies and their relationship to pretreatment symptomatology and outcome of cognitive-behavioral group treatment for social phobia.
Safren, S. A., Heimberg, R. G., & Juster, H. R. (1997) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.65.4.694 · Cited by 183 · see citing works
Monitoring of clinical trials: Issues and recommendations
Fleming, T. R., & DeMets, D. L. (1993) · Controlled Clinical Trials · doi:10.1016/0197-2456(93)90002-u · Cited by 141 · see citing works
Effectiveness of a video-based motivational skills-building HIV risk-reduction intervention for inner-city African American men.
Kalichman, S. C., Cherry, C., & Browne-Sperling, F. (1999) · Journal of Consulting and Clinical Psychology · doi:10.1037//0022-006x.67.6.959 · Cited by 124 · see citing works
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Lin, P., Appel, L. J., Funk, K., Craddick, S. R., Chen, C., Elmer, P. J., McBurnie, M. A., & Champagne, C. M. (2007) · Journal of the American Dietetic Association · doi:10.1016/j.jada.2007.06.019 · Cited by 111 · see citing works
A brief smoking cessation intervention for women in low-income planned parenthood clinics
Glasgow, R. E., Whitlock, E. P., Eakin, E., & Lichtenstein, E. (2000) · American Journal of Public Health · doi:10.2105/ajph.90.5.786 · Cited by 107 · see citing works
Internet-based health information consumer skills intervention for people living with HIV/AIDS.
Kalichman, S. C., Cherry, C., Cain, D. N., Pope, H. L., Kalichman, M. O., Eaton, L. A., Weinhardt, L. S., & Benotsch, E. G. (2006) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.74.3.545 · Cited by 98 · see citing works
Effectiveness of a video-based motivational skills-building HIV risk-reduction intervention for inner-city African American men.
Kalichman, S. C., Cherry, C., & Browne-Sperling, F. (1999) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.67.6.959 · Cited by 97 · see citing works
“Hello, hello—it’s English I speak!”: a qualitative exploration of patients’ understanding of the science of clinical trials
Stead, M., Eadie, D. R., Gordon, D., & Angus, K. (2005) · Journal of Medical Ethics · doi:10.1136/jme.2004.011064 · Cited by 94 · see citing works
Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals
Schulz, K. F. (1994) · JAMA · doi:10.1001/jama.272.2.125 · Cited by 93 · see citing works
Efficacy of a Transtheoretical Model-Based Expert System For Antihypertensive Adherence
Johnson, S. S., Driskell, M.-M., Johnson, J. L., Prochaska, J. M., Zwick, W. R., & Prochaska, J. O. (2006) · Disease Management · doi:10.1089/dis.2006.9.291 · Cited by 91 · see citing works
Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial
Turner, J. A., Jensen, M. P., Warms, C. A., & Cardenas, D. D. (2002) · Pain · doi:10.1016/s0304-3959(02)00060-x · Cited by 83 · see citing works
Piloting a behavioral intervention delivered through interactive voice response telephone messages to promote weight loss in a pre-diabetic population
Estabrooks, P. A., & Smith-Ray, R. L. (2008) · Patient Education and Counseling · doi:10.1016/j.pec.2008.01.007 · Cited by 81 · see citing works
Triple‐blind, placebo‐controlled trial of Ginkgo biloba in sexual dysfunction due to antidepressant drugs
Wheatley, D. (2004) · Human Psychopharmacology Clinical and Experimental · doi:10.1002/hup.627 · Cited by 75 · see citing works
A randomised placebo-controlled trial of a self-help Internet-based intervention for test anxiety
Orbach, G., Lindsay, S., & Grey, S. J. (2006) · Behaviour Research and Therapy · doi:10.1016/j.brat.2006.04.002 · Cited by 64 · see citing works
Behavioral Research and the Double‐Blind Placebo‐Controlled Methodology: Challenges in Applying the Biomedical Standard to Behavioral Headache Research
Rains, J. C., & Penzien, D. B. (2005) · Headache: The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2005.05099.x · Cited by 63 · see citing works
Randomized trial of problem-based versus didactic seminars for disseminating evidence-based guidelines on asthma management to primary care physicians
White, M., Michaud, G. C., Pachev, G., Lirenman, D. S., Kolenc, A., & FitzGerald, M. J. (2004) · Journal of Continuing Education in the Health Professions · doi:10.1002/chp.1340240407 · Cited by 58 · see citing works
Control groups appropriate for behavioral interventions
Whitehead, W. E. (2003) · Gastroenterology · doi:10.1053/j.gastro.2003.10.038 · Cited by 58 · see citing works
A Senior Center–Based Pilot Trial of the Effect of Lifestyle Intervention on Blood Pressure in Minority Elderly People with Hypertension
Fernandez, S., Scales, K., Pineiro, J. M., Schoenthaler, A., & Ogedegbe, G. G. (2008) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.2008.01863.x · Cited by 53 · see citing works
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Nollen, N., Ahluwalia, J., Mayo, M., Richter, K., Choi, W. S., Okuyemi, K., & Resnicow, K. (2007) · Health Education & Behavior · doi:10.1177/1090198106294652 · Cited by 52 · see citing works
Seven criteria for improving effectiveness trials in psychiatry
Tansella, M., Thornicroft, G., Barbui, C., Cipriani, A., & Saraceno, B. (2006) · Psychological Medicine · doi:10.1017/s003329170600715x · Cited by 41 · see citing works
Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention
Ulmer, M., Robinaugh, D. J., Friedberg, J. P., Lipsitz, S. R., & Natarajan, S. (2008) · Contemporary Clinical Trials · doi:10.1016/j.cct.2008.04.005 · Cited by 40 · see citing works
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Abdolrasulnia, M., Collins, B. C., Casebeer, L. L., Wall, T. C., Spettell, C. M., Ray, M. N., Weissman, N., & Allison, J. J. (2004) · BMC Medical Education · doi:10.1186/1472-6920-4-17 · Cited by 39 · see citing works
Symptom relief and the placebo effect in the trial of an anti-peptic drug.
MacDonald, A. J., Peden, N. R., Hayton, R., Mallinson, C. N., Roberts, D., & Wormsley, K. G. (1981) · Gut · doi:10.1136/gut.22.4.323 · Cited by 32 · see citing works
Adherence to Research Protocols in a Clinical Context: Challenges and Recommendations from Behavioral Intervention Trials
Johnson, M. O., & Remien, R. H. (2003) · American Journal of Psychotherapy · doi:10.1176/appi.psychotherapy.2003.57.3.348 · Cited by 27 · see citing works
Redefining the randomized controlled trial in the context of acupuncture research
Walji, R., & Boon, H. S. (2006) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2005.10.001 · Cited by 22 · see citing works
The validity and ethics of giving placebo in a randomized nonpharmacologic trial was evaluated
Spigt, M., Knipschild, P. G., van Schayck, O. C. P., & Knottnerus, J. A. (2005) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2004.08.009 · Cited by 13 · see citing works
Blindness and Bias in a Trial of Antidepressant Medication For Chronic Tension-Type Headache
Holroyd, K. A., Tkachuk, G. A., O'donnell, F., & Cordingley, G. (2006) · Cephalalgia · doi:10.1111/j.1468-2982.2006.01139.x · Cited by 5 · see citing works

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Holly, S., Jantzi, H. A., Seabrook, J. A., McEachern, L. W., Burke, S. M., Irwin, J. D., & Gilliland, J. (2023) · Nutrition Reviews · doi:10.1093/nutrit/nuad058 · Cited by 18 · see citing works
Effects of mind-body exercise on physical and psychosocial well-being of stroke patients: A systematic review and network meta-analysis
Su, J. J., Lin, R. S. Y., Baťalík, L., Abu‐Odah, H., Pepera, G., Xu, Q., & Yeung, W. (2023) · Geriatric Nursing · doi:10.1016/j.gerinurse.2023.12.011 · Cited by 18 · see citing works
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Johnson, H. M., Sullivan-Vedder, L., Kim, K., McBride, P. E., Smith, M. A., LaMantia, J. N., Fink, J. T., Sinaise, M. R. K., Zeller, L. M., & Lauver, D. (2019) · Contemporary Clinical Trials · doi:10.1016/j.cct.2019.01.010 · Cited by 19 · see citing works
Effects of mindfulness‐based interventions on neuropsychiatric symptoms and psychological well‐being on people with subjective cognitive decline and mild cognitive impairment: A meta‐analysis
Lin, R. S. Y., Su, J. J., Abu‐Odah, H., & Bayuo, J. (2023) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.5986 · Cited by 16 · see citing works
Effects of Qigong vs. routine physical exercise in school-aged children with attention-deficit hyperactivity disorder: a randomized controlled trial
Li, Y., He, Y., Wang, Y., He, J., Li, M., Wang, W.-Q., Wu, Z., Xu, Y.-J., He, W., Dou, Y.-L., et al. (2025) · World Journal of Pediatrics · doi:10.1007/s12519-025-00890-x · Cited by 15 · see citing works
Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial
Rodriguez, M. A., Wang, B., Hyoung, S., Friedberg, J. P., Wylie‐Rosett, J., Fang, Y., Allegrante, J. P., Lipsitz, S. R., & Natarajan, S. (2021) · Hypertension · doi:10.1161/hypertensionaha.120.15192 · Cited by 15 · see citing works
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Rodrigues, V. S., Horta, R. L., Szupszynski, K. P. D. R., de Souza, M. C., & Oliveira, M. D. S. (2013) · Jornal Brasileiro de Psiquiatria · doi:10.1590/s0047-20852013000300005 · Cited by 14 · see citing works
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Massey, W. V., Meyer, B. B., & Mullen, S. P. (2014) · Psychology of sport and exercise · doi:10.1016/j.psychsport.2014.09.009 · Cited by 11 · see citing works
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Teo, A. R., Hooker, E. R., Call, A. A., Dobscha, S. K., Gamble, S., Cross, W. F., & Rodgers, C. S. (2023) · Suicide and Life-Threatening Behavior · doi:10.1111/sltb.13028 · Cited by 8 · see citing works
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Pathak, A., Sharma, S., & Jensen, M. P. (2020) · OBM Integrative and Complementary Medicine · doi:10.21926/obm.icm.2001005 · Cited by 8 · see citing works
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Effect of video-assisted educational intervention on improving knowledge, attitude and practice among mothers of children below five years on malnutrition: A systematic review
Pujari, S., Rashid, M., Thunga, G., Shetty, R. S., Mundkur, S. C., Devi, E. S., Unnikrishnan, B., & Nair, S. (2025) · Public Health · doi:10.1016/j.puhe.2025.02.031 · Cited by 5 · see citing works
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Cavanaugh, K. L., & Nunes, J. A. W. (2016) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2016.06.008 · Cited by 4 · see citing works
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Schuman‐Olivier, Z., Marin, F., Kinder, L., Datko, M., Round, K., Tohyama, S., Garcia, R. G., Hirschtick, R., Edwards, R. R., Wells, R. E., et al. (2025) · Contemporary Clinical Trials · doi:10.1016/j.cct.2025.107947 · Cited by 3 · see citing works
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Sharma, K. K., Gupta, R., Choyal, T., Sharma, K. K., Sharma, D., & Sharma, T. (2025) · ERJ Open Research · doi:10.1183/23120541.00258-2025 · Cited by 3 · see citing works
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Hancock, S., Thayabaranathan, T., Stolwyk, R. J., Cameron, J., Immink, M. A., Hillier, S., Kilkenny, M. F., Brodtmann, A. G., Carey, L. M., Olaiya, M. T., et al. (2025) · Mindfulness · doi:10.1007/s12671-025-02579-8 · Cited by 3 · see citing works
Primary care models and depression outcomes in rural adult populations: A systematic review.
Turi, E. R., Courtwright, S. E., Dixon, J., O'Neill, I., Marchiano, M., & Poghosyan, L. (2024) · Rural Mental Health · doi:10.1037/rmh0000261 · Cited by 2 · see citing works
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Martín-Olmedo, J. J., Jurado‐Fasoli, L., Osuna‐Prieto, F. J., García‐Fontana, C., García-Fontana, B., Gracia‐Marco, L., Muñoz‐Torres, M., & Ruiz, J. R. (2025) · European Journal of Endocrinology · doi:10.1093/ejendo/lvaf087 · Cited by 2 · see citing works
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Barrera, J. A., Straube, L. D., Huml, Z., Yielder, R., Zion, S. R., Evans, K. M., Louis, K., Moriarity, D. P., Gasteiger, C., Slavich, G. M., et al. (2025) · Brain Behavior and Immunity · doi:10.1016/j.bbi.2025.07.011 · Cited by 2 · see citing works
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Sterling, M. R., Espinosa, C. G., Vergez, S., McDonald, M. V., Ringel, J. B., Tobin, J. N., Banerjee, S., Dell, N. L., Kern, L. M., & Safford, M. M. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.48121 · Cited by 2 · see citing works
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Annaswamy, T. M., Cunniff, K., Rizzo, J., Naeimi, T., Kumbhare, D. A., & Batavia, M. (2023) · American Journal of Physical Medicine & Rehabilitation · doi:10.1097/phm.0000000000002228 · Cited by 2 · see citing works
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Graham, C. W., & West, M. D. (2014) · Campbell Systematic Reviews · doi:10.1002/cl2.134 · Cited by 1 · see citing works
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Yazeedi, B. M. A., Al-Hadabi, B., Waly, M. I., Al‐Adawi, S., Al‐Mammari, S., Al-Ghammari, I. K., Al-Shammakhi, S. M., Azkawi, H. S. A., & Khalaf, A. (2024) · Clinical Obesity · doi:10.1111/cob.12719 · Cited by 1 · see citing works
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O’Keeffe, S. (2026) · Trials · doi:10.1186/s13063-026-09698-0
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Authors: Friedberg, J. P., Lipsitz, S. R., & Natarajan, S.
Affiliations: VA NY Harbor Healthcare System (US)
Brigham and Women's Hospital (US)
Corresponding author: Friedberg, Jennifer P.
ORCID: Lipsitz, Stuart R.
Natarajan, Sundar
Venue: Patient Education and Counseling
Publisher: Elsevier BV
Published: 2010-01
Volume: 78
Issue: 1
Pages: 5-11
ISSN: 0738-3991 (ISSN-L)
DOI: 10.1016/j.pec.2009.04.009
OpenAlex: W2057956458
Cited by: 82
References: 48
Citations by year: 2026: 5 · 2025: 15 · 2024: 12 · 2023: 9 · 2022: 6 · 2021: 6 · 2020: 8 · 2019: 4 · 2018: 2 · 2017: 2 · 2016: 3 · 2014: 4 · 2013: 4
FWCI: 0.07
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Patient Education and Counseling (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (CA 74015, CA 069222, R01CA074015)
National Institute of General Medical Sciences (GM29745, R01GM029745)
National Institute of Allergy and Infectious Diseases (AI 60373, R01AI060373)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: blinding, behavioral interventions, randomized controlled trials, hypertension control, blood pressure reduction, counseling intervention, bias mitigation
MeSH terms: Behavior Therapy, Blood Pressure, Humans, Hypertension, Randomized Controlled Trials as Topic

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Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure

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