The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

Freedland, Kenneth E.; King, Abby C.; Ambrosius, Walter T.; Mayo-Wilson, Evan; Mohr, David C.; Czajkowski, Susan M.; Thabane, Lehana; Collins, Linda M.; Rebok, George W.; Treweek, Shaun P.; Cook, Thomas D.; Edinger, Jack D.; Stoney, Catherine M.; Campo, Rebecca A.; Young-Hyman, Deborah; Riley, William T.

doi:10.1016/j.jclinepi.2019.02.011

Cited by 218Statistical Methods in Clinical TrialsHealth Policy Implementation ScienceMeta-analysis and systematic reviews

The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

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Freedland, Kenneth E., King, Abby C., Ambrosius, Walter T., Mayo-Wilson, Evan, Mohr, David C., Czajkowski, Susan M., Thabane, Lehana, Collins, Linda M. +8 more·2019·Journal of Clinical Epidemiology

DOI 10.1016/j.jclinepi.2019.02.011PMC PMC6543841

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Abstract

Objectives To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions.Study design and setting The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators.Results The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account.Conclusion We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.

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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 [26]
The Research ethics section says comparator conditions can pose risks and harms to participants, including risks from exposure to the comparator itself. The paper identifies attention-control conditions as comparators in Choosing the optimal comparator, but our copy does not specifically say that attention controls can have unintended detrimental effects. No page numbers are available in our copy. (LLM, conf=0.78)
Experimental — accuracy not yet measured
The EUC condition consisted of fatigue-specific educational materials which exceeds typical clinical offerings.
“We compared REVITALIZE to an EUC condition consisting of fatigue-specific educational materials which exceeds typical clinical offerings [26,27]”
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 [26]
The 'Choosing the optimal comparator' section discusses usual care and other comparator types in general, but does not describe the REVITALIZE trial or its EUC condition. Searches for REVITALIZE, fatigue-specific educational materials, and enhanced usual care found no passage establishing what the condition contained or whether it exceeded typical clinical offerings. (LLM, conf=0.76)
Experimental — accuracy not yet measured
Studies with non-therapeutic control conditions can establish the impact of non-specific factors but cannot provide the highest comparison strength.
“Studies with non-therapeutic control conditions are still scientifically valuable as they can establish the impact of non-specific factors12, but they cannot provide the highest comparison strength.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]
There is no single control condition that is appropriate for every study at every stage of the research process.
“There is no single control condition that is appropriate for every study at every stage of the research process11,12,39.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]
Clarifying the universe of mHealth control condition types can help highlight the scientific questions each type can reasonably address and comparison strength each type provides.
“Clarifying the universe of mHealth control condition types can help highlight the scientific questions each type can reasonably address and comparison strength each type provides12.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]

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Higgins, J. P. T., Altman, D. G., Gotzsche, P. C., Juni, P., Moher, D., Oxman, A. D., Savovic, J., Schulz, K. F., Weeks, L., Sterne, J. A. C., et al. (2011) · BMJ · doi:10.1136/bmj.d5928 · Cited by 33,817 · see citing works
The “Golden Age” of Probiotics: A Systematic Review and Meta-Analysis of Randomized and Observational Studies in Preterm Infants
Dermyshi, E., Wang, Y., Yan, C., Hong, W., Qiu, G., Gong, X., & Zhang, T. (2017) · Neonatology · doi:10.1159/000454668 · Cited by 24,577 · see citing works
Untitled work
(2002) · Cited by 13,211 · see citing works
Self-citation
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Research design in clinical psychology
Kazdin, A. E. (1952) · Journal of Clinical Psychology · doi:10.1002/1097-4679(195201)8:1 · Cited by 2,153 · see citing works
The PRECIS-2 tool: designing trials that are fit for purpose
Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K. E., & Zwarenstein, M. (2015) · BMJ · doi:10.1136/bmj.h2147 · Cited by 1,846 · see citing works
Self-citation
From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases
Czajkowski, S. M., Powell, L. H., Adler, N., Naar-King, S., Reynolds, K. D., Hunter, C. M., Laraia, B., Olster, D. H., Perna, F. M., Peterson, J. C., et al. (2015) · Health Psychology · doi:10.1037/hea0000161 · Cited by 1,161 · cited 2× · see citing works
“Similarly, in the Design phase (Phase I) of t he Obesity-Related Behavioral Intervention Trials (ORBIT) framework for developing behavioral interventions [30], small-N or single-case designs examine the intervention’s components, dosa ge parameters, targets, and modes of delivery without between-group comparators.”
BackgroundMethodSelf-citation
Indirect comparisons of competing interventions
Glenny, A., Altman, D. G., Song, F., Sakarovitch, C., Deeks, J. J., D’Amico, R., Bradburn, M. J., & Eastwood, A. J. (2005) · Health Technology Assessment · doi:10.3310/hta9260 · Cited by 681 · see citing works
Psychological and pharmacological interventions for social anxiety disorder in adults: a systematic review and network meta-analysis
Mayo-Wilson, E., Dias, S., Mavranezouli, I., Kew, K., Clark, D. M., Ades, A. E., & Pilling, S. (2014) · The Lancet Psychiatry · doi:10.1016/s2215-0366(14)70329-3 · Cited by 680 · see citing works
Self-citation
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Mohr, D. C., Spring, B., Freedland, K. E., Beckner, V., Arean, P., Hollon, S. D., Ockene, J., & Kaplan, R. (2009) · Psychotherapy and Psychosomatics · doi:10.1159/000228248 · Cited by 565 · see citing works
Self-citation
Waiting list may be a nocebo condition in psychotherapy trials: a contribution from network meta-analysis
Furukawa, T. A., Noma, H., Caldwell, D. M., Honyashiki, M., Shinohara, K., Imai, H., Chen, P., Hunot, V., & Churchill, R. (2014) · Acta Psychiatrica Scandinavica · doi:10.1111/acps.12275 · Cited by 521 · see citing works
A Systematic Review of Community‐Based Participatory Research to Enhance Clinical Trials in Racial and Ethnic Minority Groups
De Las Nueces, D., Hacker, K., DiGirolamo, A., & Hicks, L. S. (2012) · Health Services Research · doi:10.1111/j.1475-6773.2012.01386.x · Cited by 400 · see citing works
Usual and Unusual Care: Existing Practice Control Groups in Randomized Controlled Trials of Behavioral Interventions
Freedland, K. E., Mohr, D. C., Davidson, K. W., & Schwartz, J. E. (2011) · Psychosomatic Medicine · doi:10.1097/psy.0b013e318218e1fb · Cited by 369 · see citing works
Self-citation
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Self-citation
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Bero, L. A., & Jadad, A. R. (1997) · Annals of Internal Medicine · doi:10.7326/0003-4819-127-1-199707010-00007 · Cited by 198 · see citing works
Posing the research question: not so simple
Thabane, L., Thomas, T., Ye, C., & Paul, J. (2008) · Canadian Journal of Anesthesia/Journal canadien d anesthésie · doi:10.1007/s12630-008-9007-4 · Cited by 178 · see citing works
Self-citation
Behavioral Intervention Research: Designing, Evaluating, and Implementing
Gitlin, L. N., & Czaja, S. J. (2015) · Springer Publishing Company eBooks · doi:10.1891/9780826126597 · Cited by 149 · see citing works
Context effects and behaviour change techniques in randomised trials: A systematic review using the example of trials to increase adherence to physical activity in musculoskeletal pain
Bishop, F. L., Fenge-Davies, A. L., Kirby, S., & Geraghty, A. W. A. (2015) · Psychology & Health · doi:10.1080/08870446.2014.953529 · Cited by 121 · see citing works
Methodological issues & strategies in clinical research.
Imber, S. D., Glanz, L. M., Elkin, I., Sotsky, S. M., Boyer, J. L., & Leber, W. R. (1992) · American Psychological Association eBooks · doi:10.1037/10109-000 · Cited by 114 · see citing works
National Depressive and Manic-Depressive Association Consensus Statement on the Use of Placebo in Clinical Trials of Mood Disorders
Charney, D. S. (2002) · Archives of General Psychiatry · doi:10.1001/archpsyc.59.3.262 · Cited by 113 · see citing works
The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent
Brim, R. L., & Miller, F. G. (2012) · Journal of Medical Ethics · doi:10.1136/medethics-2012-101045 · Cited by 91 · see citing works
Fundamentals of Clinical Trials
(2011) · Wiley series in probability and statistics · doi:10.1002/9781118183335.ch2 · Cited by 81 · see citing works
Control Groups in Psychosocial Intervention Research: Ethical and Methodological Issues
Street, L. L., & Luoma, J. B. (2002) · Ethics & Behavior · doi:10.1207/s15327019eb1201_1 · Cited by 55 · see citing works
International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.
(2001) · PubMed · Cited by 46 · see citing works
Varieties of Standard-of-Care Treatment Randomized Trials
Kim, S. Y. H., & Miller, F. G. (2015) · JAMA · doi:10.1001/jama.2014.18528 · Cited by 26 · see citing works
High-quality psychotherapy research from conception to piloting to national trials
Areán, P. A., & KRAEMER, H. C. (2013) · Cited by 17 · see citing works
High‐quality psychotherapy research: from conception to piloting to national trials
Hayes, J. (2013) · Counselling and Psychotherapy Research · doi:10.1080/14733145.2013.855538 · Cited by 10 · see citing works

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[9]Freedland KE. Design and conduct of randomized behavioral clinical trials: Purpose-guided trial design. International Journal of Behavioral Medicine. 2014; 21: S1.

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Clinician's Guide to Evaluating and Developing eHealth Interventions for Mental Health
Ondersma, S. J., & Walters, S. T. (2020) · Psychiatric Research and Clinical Practice · doi:10.1176/appi.prcp.2020.20190036 · Cited by 16 · see citing works
Reactions to being allocated to a waiting list control group in a digital alcohol intervention trial
Gunnarsson, K. U., McCambridge, J., & Bendtsen, M. (2022) · Patient Education and Counseling · doi:10.1016/j.pec.2022.11.014 · Cited by 17 · see citing works
Comparator Groups in ICU-Based Studies of Physical Rehabilitation: A Scoping Review of 125 Studies
O’Grady, H. K., Reid, J. C., Farley, C., Hanna, Q. E. B., Unger, J., Zorko, D. J., Bosch, J., Turkstra, L. S., & Kho, M. E. (2023) · Critical Care Explorations · doi:10.1097/cce.0000000000000917 · Cited by 17 · see citing works
Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D. R., Jago, R., Burkart, S. A., Weaver, R. G., Armstrong, B., Pfledderer, C. D., & Beets, M. W. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-00991-8 · Cited by 17 · see citing works
Variability in effect sizes of exercise therapy for knee osteoarthritis depending on comparator interventions
Pedersen, J. R., Dilara Merve, S. A. R. I., Juhl, C. B., Thorlund, J. B., Skou, S. T., Roos, E. M., & Bricca, A. (2022) · Annals of Physical and Rehabilitation Medicine · doi:10.1016/j.rehab.2022.101708 · Cited by 16 · see citing works
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Lorenzo‐Luaces, L., & Howard, J. (2023) · Journal of Medical Internet Research · doi:10.2196/45411 · Cited by 16 · see citing works
Early childhood educator outcomes from online professional development for physical literacy: A randomised controlled trial
Simpson, A., Stein, M., Rosenberg, M., Ward, B., Derbyshire, A., Thornton, A., & Jackson, B. (2023) · Psychology of sport and exercise · doi:10.1016/j.psychsport.2023.102464 · Cited by 16 · see citing works
Efficacy of a Brief Tele–Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress
Graboyes, E. M., Maurer, S. N., Balliet, W. E., Li, H., Williams, A. M., Osazuwa‐Peters, N., Yan, F., Padgett, L. S., Rush, A., Ruggiero, K. J., et al. (2022) · JAMA Otolaryngology–Head & Neck Surgery · doi:10.1001/jamaoto.2022.3700 · Cited by 16 · see citing works
Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease
Rawson, K. S., Cavanaugh, J. T., Colón-Semenza, C., DeAngelis, T., Duncan, R. P., Fulford, D., LaValley, M. P., Mazzoni, P., Nordahl, T. J., Quintiliani, L. M., et al. (2020) · BMC Neurology · doi:10.1186/s12883-020-01718-z · Cited by 16 · see citing works
Casting New Light on Statistical Power: An Illuminating Analogy and Strategies to Avoid Underpowered Trials
Kiernan, M., & Baiocchi, M. (2022) · American Journal of Epidemiology · doi:10.1093/aje/kwac019 · Cited by 17 · see citing works
The Sleep, Cancer and Rest (SleepCaRe) Trial: Rationale and Design of a Randomized, Controlled Trial of Four Interventions for Insomnia and Fatigue in Women with Breast Cancer Receiving Chemotherapy
Maccora, J., Garland, S. N., Ftanou, M., Day, D., White, M. A., Lopez, V. A., Mortimer, D., Diggens, J., Phillips, A. J. K., Wallace, R., et al. (2022) · Contemporary Clinical Trials · doi:10.1016/j.cct.2022.106877 · Cited by 17 · see citing works
Implementing NIH Behavior Change Consortium Treatment Fidelity Recommendations in a Multi-Site Randomized Controlled Trial of an Active Music Engagement Intervention for Young Children with Cancer and Parents
MacLean, J. A., Stegenga, K. A., Henley, A. K., & Robb, S. L. (2022) · Integrative Cancer Therapies · doi:10.1177/15347354221140491 · Cited by 14 · see citing works
Systematic review and meta-analysis of interventions to promote medication adherence among children, adolescents, and young adults with medical conditions
McGrady, M. E., Keenan-Pfeiffer, M. E., Lang, A. C., Noser, A. E., Tyagi, A. P., Herriott, J. K., & Ramsey, R. R. (2024) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsae036 · Cited by 15 · see citing works
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Huberty, J., Eckert, R., Puzia, M., Laird, B., Larkey, L., & Mesa, R. A. (2020) · JMIR Formative Research · doi:10.2196/19364 · Cited by 13 · see citing works
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Murray, H. B., Guadagnoli, L. A., Kamp, K., Trindade, I. A., Powell, L. H., Simrén, M., Ljótsson, B., & Keefer, L. (2025) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.18482 · Cited by 13 · see citing works
Cognitive Behavioural Therapy and Light Dark Therapy for Maternal Postpartum Insomnia Symptoms: Protocol of a Parallel-Group Randomised Controlled Efficacy Trial
Verma, S., Rajaratnam, S. M. W., Davey, M. J., Wiley, J. F., & Bei, B. (2021) · Frontiers in Global Women s Health · doi:10.3389/fgwh.2020.591677 · Cited by 13 · see citing works
Comparing Web-Based and Classroom-Based Memory Training for Older Adults: The ACTIVE Memory Works™ Study
Rebok, G. W., Tzuang, M., & Parisi, J. M. (2019) · The Journals of Gerontology Series B · doi:10.1093/geronb/gbz107 · Cited by 13 · see citing works
Self-citation
ACT with CF: A randomized trial of acceptance and commitment therapy vs supportive psychotherapy for adults with cystic fibrosis.
O'Hayer, C. V., Smith, P. J., Drescher, C. F., Bruschwein, H., Nurse, C. N., Kushner, H. M., Ingle, K., Stephen, M. J., & Hoag, J. B. (2024) · General Hospital Psychiatry · doi:10.1016/j.genhosppsych.2024.11.011 · Cited by 12 · see citing works
Power analysis for idiographic (within-subject) clinical trials: Implications for treatments of rare conditions and precision medicine
Tueller, S., Ramirez, D., Cance, J. D., Ye, A., Wheeler, A., Fan, Z., Hornik, C. P. V., & Ridenour, T. A. (2022) · Behavior Research Methods · doi:10.3758/s13428-022-02012-1 · Cited by 12 · see citing works
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Harris‐Hayes, M., Zorn, P., Steger-May, K., Burgess, M. M., DeMargel, R. D., Kuebler, S., Clohisy, J. C. F., & Haroutounian, S. (2023) · Physical Therapy · doi:10.1093/ptj/pzad111 · Cited by 12 · see citing works
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Garbett, K. M., Craddock, N., Haywood, S., Nasution, K., White, P., Saraswati, L. A., Medise, B. E., Effect, G., Galactic, P., Diedrichs, P. C., et al. (2021) · JMIR Research Protocols · doi:10.2196/33596 · Cited by 12 · see citing works
Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress
Graboyes, E. M., Kistner‐Griffin, E., Hill, E. G., Maurer, S. N., Balliet, W. E., Williams, A. M., Padgett, L. S., Yan, F., Rush, A., Johnson, B., et al. (2023) · Supportive Care in Cancer · doi:10.1007/s00520-023-08248-7 · Cited by 12 · see citing works
Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue
Wright, A. A., Poort, H., Tavormina, A., Schmiege, S. J., Matulonis, U. A., Campos, S. M., Liu, J. F., Slivjak, E. T., Gilmour, A. L., Salinger, J. M., et al. (2023) · Gynecologic Oncology · doi:10.1016/j.ygyno.2023.08.020 · Cited by 11 · see citing works
The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers
Bechthold, A. C., Azuero, A., Pisu, M., Pierce, J. Y., Williams, G. R., Taylor, R. A., Wells, R., Curry, K., Reed, R. D., Harrell, E. R., et al. (2022) · Trials · doi:10.1186/s13063-022-06305-w · Cited by 12 · see citing works
A framework for designing hybrid effectiveness-implementation trials for digital health interventions
Matson, T. E., Hermes, E. D. A., Lyon, A. R., Quanbeck, A., Schueller, S. M., Wilson, S. M., & Glass, J. E. (2025) · Annals of Epidemiology · doi:10.1016/j.annepidem.2025.02.007 · Cited by 11 · see citing works
‘Dove Confident Me Indonesia: Single Session’: study protocol for a randomised controlled trial to evaluate a school-based body image intervention among Indonesian adolescents
Craddock, N., Garbett, K. M., Haywood, S., Nasution, K., White, P., Saraswati, L. A., Rizkiah, C., Medise, B. E., & Diedrichs, P. C. (2021) · BMC Public Health · doi:10.1186/s12889-021-11770-0 · Cited by 11 · see citing works
Pilot randomized controlled trial of a video self‐help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability
Gaudiano, B. A., Davis, C. H., Miller, I. W., & Uebelacker, L. A. (2020) · Clinical Psychology & Psychotherapy · doi:10.1002/cpp.2436 · Cited by 12 · see citing works
Learning from community-led and co-designed m-health interventions
Duncan, M. J., & Kolt, G. S. (2019) · The Lancet Digital Health · doi:10.1016/s2589-7500(19)30125-6 · Cited by 9 · see citing works
The control group matters: Pain, physical function and strength improvements relative to the comparator intervention in knee and hip osteoarthritis
Marriott, K. A., Hall, M., Maciukiewicz, J. M., Almaw, R. D., Wiebenga, E. G., Ivanochko, N. K., Rinaldi, D., Tung, E. V., Bennell, K. L., & Maly, M. R. (2024) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2024.152538 · Cited by 10 · see citing works
Comments, suggestions, and criticisms of the Pragmatic Explanatory Continuum Indicator Summary-2 design tool: a citation analysis
Willis, A., Shiely, F., Treweek, S. P., Taljaard, M., Loudon, K., Howie, A. H., & Zwarenstein, M. (2024) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2024.111534 · Cited by 10 · see citing works
Self-citation
Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study
Castañeda, S. F., Gallo, L. C., Garcia, M. L., Mendoza, P., Gutierrez, A. P., Lopez-Gurrola, M., Roesch, S. C., Pichardo, M. S., Munoz, F. A., & Talavera, G. A. (2022) · Translational Behavioral Medicine · doi:10.1093/tbm/ibac042 · Cited by 10 · see citing works
Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial
Agley, J. D., Jayawardene, W. P., Jun, M. C., Agley, D., Gassman, R. A., Sussman, S. Y., Xiao, Y., & Dickinson, S. (2020) · JMIR Research Protocols · doi:10.2196/17900 · Cited by 10 · see citing works
The Support, Educate, Empower personalized glaucoma coaching trial design
Newman-Casey, P. A., Resnicow, K., Winter, S. M., Niziol, L. M., Darnley-Fisch, D. A., Imami, N. R., McHaney-Conner, P., Musch, D. C., Mitchell, J. A., & Heisler, M. (2023) · Clinical Trials · doi:10.1177/17407745221136571 · Cited by 10 · see citing works
The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences
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Meyer, B., Betz, L. T., Brückner, K., & Holtkamp, M. (2024) · Epilepsia Open · doi:10.1002/epi4.13014 · Cited by 9 · see citing works
Has the time come to stop using control groups in trials of psychosocial interventions?
Cuijpers, P. J. (2025) · World Psychiatry · doi:10.1002/wps.21359 · Cited by 9 · see citing works
Improving the recognition and management of hemorrhage: A scoping review of nursing and midwifery education
Lavoie, P., Lapierre, A., Maheu‐Cadotte, M., Rodriguez, D., Lavallée, A., & Mailhot, T. (2022) · Nurse Education Today · doi:10.1016/j.nedt.2022.105361 · Cited by 10 · see citing works
Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study
Pratscher, S. D., Sibille, K. T., & Fillingim, R. B. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01247-9 · Cited by 8 · see citing works
Progress in conducting and reporting behaviour change intervention studies: a prospective retrospection
Johnston, M. (2021) · Health Psychology and Behavioral Medicine · doi:10.1080/21642850.2021.1939701 · Cited by 8 · see citing works
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Ymer, L., McKay, A., Wong, D. K., & Ponsford, J. L. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01070-8 · Cited by 7 · see citing works
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Blonigen, D. M., Hyde, J. K., McInnes, D. K., Yoon, J., Byrne, T. H., Ngo, T., & Smelson, D. A. (2022) · Contemporary Clinical Trials · doi:10.1016/j.cct.2022.107065 · Cited by 7 · see citing works
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Waki, K., Tsurutani, Y., Waki, H., Enomoto, S., Kashiwabara, K., Fujiwara, A., Orime, K., Kinguchi, S., Yamauchi, T., Hirawa, N., et al. (2024) · JMIR Research Protocols · doi:10.2196/53514 · Cited by 7 · see citing works
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Bendtsen, M., Gunnarsson, K. U., & McCambridge, J. (2021) · BMJ Open · doi:10.1136/bmjopen-2021-049810 · Cited by 7 · see citing works
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Caldwell, D. M., Palmer, J. C., Webster, K. E., Davies, S. R., Hughes, H., Rona, J., Churchill, R. C., Hetrick, S. E., & Welton, N. J. (2025) · Prevention Science · doi:10.1007/s11121-025-01786-y · Cited by 4 · see citing works
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D’Amelio, R., Betz, L. T., Jow, S. M., Retz, W., Philipsen, A., Klein, J. P., Faßbinder, E., Jacob, G. A., & Retz‐Junginger, P. (2026) · Psychological Medicine · doi:10.1017/s0033291726103390 · Cited by 7 · see citing works
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Barr, P. J., Masel, M. C., Bratches, R. W., Carpenter-Song, E. A., O’Malley, A. J., BRUCE, M. L., Goodwin, J. S., Kripalani, S. B., Tarczewski, S., Williams, S., et al. (2024) · Patient Education and Counseling · doi:10.1016/j.pec.2024.108574 · Cited by 5 · see citing works
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Royer, M. F., & Wharton, C. M. (2023) · Challenges · doi:10.3390/challe14040043 · Cited by 6 · see citing works
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Fitzgeraldson, E., Fitzpatrick, S., Dizon, J., & KAY‐LAMBKIN, F. J. (2024) · Advances in Mental Health · doi:10.1080/18387357.2024.2324103 · Cited by 6 · see citing works
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Kim, M., Mansour-Assi, S., Mistiri, M. E., Park, J.-H., Banerjee, S., Khan, O., Torre, S. A. D. L., Higgins, M., Godino, J., Patrick, K., et al. (2025) · JMIR Research Protocols · doi:10.2196/70599 · Cited by 6 · see citing works
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Scandiffio, J., Langer, L. K., Senthilnathan, V., Feng, G., Sureshkumar, A., Bromberg, M., Babineau, J., Donkers, S. J., Knox, K. B., Bruno, T. R., et al. (2025) · Journal of Neurology · doi:10.1007/s00415-025-13315-6 · Cited by 8 · see citing works
SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols
Baba, A., Smith, M., Potter, B. K., Chan, A.-W., Moher, D., Toulany, A., Doherty-Kirby, A., Escalera, B. N., Stratton, C., Gale, C., et al. (2026) · British medical journal · doi:10.1136/bmj-2025-085064 · Cited by 7 · see citing works
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Earnshaw, V. A., Sepucha, K., Laurenceau, J., Subramanian, S. V., Hill, E. C., Wallace, J., Brousseau, N. M., Henderson, C., Brohan, E., Morrison, L. M., et al. (2023) · Journal of Substance Use and Addiction Treatment · doi:10.1016/j.josat.2024.209291 · Cited by 5 · see citing works

The Choice of a Comparator
Powell, L. H., Kaufmann, P. G., & Freedland, K. E. (2021) · Springer eBooks · doi:10.1007/978-3-030-39330-4_6
Self-citation
Purpose-guided trial design in health-related behavioral intervention research.
Freedland, K. E. (2020) · Health Psychology · doi:10.1037/hea0000867 · Cited by 32 · see citing works
Self-citation
Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology reviewPreprint
Turner, K. M., Huntley, A. L., Yardley, T., Dawson, S., & Dawson, S. (2023) · Research Square · doi:10.21203/rs.3.rs-3466362/v1 · Cited by 2 · see citing works
Additional file 1 of Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review
Turner, K. M., Huntley, A. L., Yardley, T., Dawson, S., & Dawson, S. (2024) · Figshare · doi:10.6084/m9.figshare.25203622
The Trials and Tribulations of Selecting Comparison Groups in Randomized Trials of Nonpharmacological Complementary and Integrative Health Interventions
Sherman, K. J. (2020) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2019.0460 · Cited by 13 · see citing works

Authors: Freedland, K. E., King, A. C., Ambrosius, W. T., Mayo-Wilson, E., Mohr, D. C., Czajkowski, S. M., Thabane, L., Collins, L. M., Rebok, G. W., Treweek, S. P., Cook, T. D., Edinger, J. D., Stoney, C. M., Campo, R. A., Young-Hyman, D., & Riley, W. T.
Affiliations: Washington University in St. Louis (US)
Stanford Medicine (US)
Wake Forest University Health Sciences (US)
Northwestern University (US)
National Institutes of Health (US)
McMaster University (CA)
Pennsylvania State University (US)
Johns Hopkins University (US)
University of Aberdeen (GB)
National Jewish Health (US)
National Heart, Lung, and Blood Institute (US)
Corresponding author: Freedland, Kenneth E.
ORCID: Freedland, Kenneth E.
King, Abby C.
Ambrosius, Walter T.
Mayo-Wilson, Evan
Mohr, David C.
Czajkowski, Susan M.
Thabane, Lehana
Collins, Linda M.
Rebok, George W.
Treweek, Shaun P.
Cook, Thomas D.
Edinger, Jack D.
Stoney, Catherine M.
Campo, Rebecca A.
Young-Hyman, Deborah
Riley, William T.
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2019-06
Volume: 110
Pages: 74-81
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/j.jclinepi.2019.02.011
PMC: PMC6543841
OpenAlex: W2918272982
Cited by: 218
References: 27
Citations by year: 2026: 32 · 2025: 35 · 2024: 37 · 2023: 34 · 2022: 36 · 2021: 21 · 2020: 17 · 2019: 6
FWCI: 15.57
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
IUScholarWorks Open (Indiana University) (submittedVersion)
UNC Libraries
Funders: National Institutes of Health (Z99 HL999999)
National Heart, Lung, and Blood Institute (R01HL147862, R01HL119286)
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 › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: comparator selection, control groups, randomized controlled trials, best practice recommendations, trial design
MeSH terms: Mental Disorders, Female, Humans, Male, National Institutes of Health (U.S.), Psychotherapy, Research Design, United States, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Patient Selection

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The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

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