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Exploratory randomized controlled trial evaluating the impact of a waiting list control design
Open accessAbstract
BACKGROUND: Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates. This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers, one domain of research in which waiting list control designs are used. METHODS: All participants (N = 185) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime. RESULTS: A total of 157 participants (85%) were followed-up after 4 weeks. Between-group differences were found in one of four outcomes (proportion within safe drinking guidelines). An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list. CONCLUSIONS: Trials with waiting list control conditions may overestimate treatment effects, though the extent of any such bias appears likely to vary between study populations. Arguably they should only be used where this threat to valid inference has been carefully assessed.
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“The literature reports growing concerns over the use of waitlist style control groups in psychotherapy research, as the outcomes of the interventions may be over-estimated with this type of control.64”
From Workplace interventions to improve well-being and reduce burnout for nurses, physicians and allied healthcare professionals: a systematic review. (2023) · cites this paper as [64]
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“Intervention outcomes should also be interpreted with caution because of the potential for overestimation of effect sizes when a waitlist comparison group is used in behavior change research [106].”
From Evaluation of an App-Delivered Psychological Flexibility Skill Training Intervention for Medical Student Burnout and Well-being: Randomized Controlled Trial (2023) · cites this paper as [106]
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“previous research suggests that waitlist participants’ expectations of receiving support at a later time could hinder the self-driven behavior change that they might otherwise have made during the same period [106].”
From Evaluation of an App-Delivered Psychological Flexibility Skill Training Intervention for Medical Student Burnout and Well-being: Randomized Controlled Trial (2023) · cites this paper as [106]
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“it has been noted that such designs may overestimate intervention effects [84].”
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“A drawback of this design is that it might artificially inflate intervention effect estimates since participants in the control group could have been influenced by design to literally “wait-tochange” and thus do not improve.(37) However, this does not seem to be the case in our study, since control participants also s…”
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“While there are ethical advantages to a waitlist design because it allows for the provision of care to research participants who are seeking help while permitting a non-intervention evaluation, such design may overestimate intervention effects (163).”
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“It is possible that such designs may overestimate intervention effects; in contrast with studies using active control (placebo) designs, participants assigned to a waiting list control condition appear to improve little or not at all [4].”
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“Concerns have been raised that this type of study design can lead to over-estimated intervention effects (120).”
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“This study was not designed as a classic randomized trial and the waiting list control methodology theoretically may inflate effectiveness of the intervention, although data in this regard is quite thin.(48) Generalizability of these findings may be restricted since the method was not developed to actively include and…”
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“Therefore, concerns about possible biases in waiting list designs arising out of disappointment cannot be ruled out [28, 45].”
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“The traditional waiting-list designs seem to overestimate the effect of interventions [46].”
BackgroundOgba, F. N., Onyishi, C. N., Ede, M. O., Ugwuanyi, C. S., Nwokeoma, B. N., Victor-Aigbodion, V., Eze, U. N., Omeke, F. C., Okorie, C. O., & Ossai, O. V. (2019) · Journal of Rational-Emotive & Cognitive-Behavior Therapy · doi:10.1007/s10942-019-00334-2 · Cited by 35
Castro-Camacho, L., Barlow, D. H., Mejía, N. G., Farchione, T. J., Idrobo, F., Rattner, M., Quant, D. M., González, L., & Moreno-Villamizar, J. D. (2023) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2023.2392 · Cited by 34
Maciel, L. P. A. A., Pomares, A. G., Day, C., & Basto-Pereira, M. (2023) · Clinical Psychology Review · doi:10.1016/j.cpr.2023.102274 · Cited by 36
Hendriks, T., Schotanus-Dijkstra, M., Hassankhan, A., Sardjo, W., Graafsma, T., Bohlmeijer, E., & de Jong, J. (2020) · The Journal of Positive Psychology · doi:10.1080/17439760.2019.1590624 · Cited by 30
Tan, Z. Y. A., Wong, S. H., Cheng, L. J., & Lau, S. T. (2022) · Mindfulness · doi:10.1007/s12671-022-01962-z · Cited by 33
“1 3 to wait to change until they receive mMBIs (Cunningham et al., 2013).”
BackgroundFriedrich, A., Claßen, M., & Schlarb, A. A. (2018) · BMC Psychiatry · doi:10.1186/s12888-018-1860-2 · Cited by 33
Abreu, L. G., dos Santos, T. R., Melgaço, C. A., de Abreu, M. H. N. G., Lages, E. M. B., & Paiva, S. M. (2018) · Quality of Life Research · doi:10.1007/s11136-018-1830-7 · Cited by 29
“The literature has expressed concern with the use of waiting list design in intervention research [31].”
BackgroundRitzert, T. R., Forsyth, J. P., Sheppard, S. C., Boswell, J. F., Berghoff, C. R., & Eifert, G. H. (2016) · Behavior Therapy · doi:10.1016/j.beth.2016.03.001 · Cited by 28
Finlay‐jones, A. L., Parkinson, A., Sirois, F. M., Perry, Y., Boyes, M. E., & Rees, C. S. (2023) · Journal of Medical Internet Research · doi:10.2196/44016 · Cited by 34
“Although this was appropriate given the early stage of testing of the SCO-CMC program and the minimal-contact nature of the program, the use of the waitlist control group can artificially inflate the estimates of treatment effects [82].”
MethodThe Inflating Impact of Waiting-List Controls on Effect Size Estimates
Laws, K. R., Pellegrini, L., Reid, J. E., Drummond, L. M., & Fineberg, N. A. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.877089 · Cited by 27
“As with our own meta-analysis (2), our re-analysis of the data here shows that waiting list control groups inflate effect sizes [see (10, 11)].”
Guided web-based treatment program for reducing cannabis use: a randomized controlled trial
Sinadinovic, K., Johansson, M., Johansson, A.-S., Lundqvist, T., Lindner, P., & Hermansson, U. (2020) · Addiction Science & Clinical Practice · doi:10.1186/s13722-020-00185-8 · Cited by 35
“group allocation as well as waiting times which hopefully reduced the risk of being negatively affected by being allocated to the control group [38, 39].”
BackgroundSchaub, M. P., Tiburcio, M., Martinez, N., Ambekar, A., Balhara, Y. P. S., Wenger, A., Monezi Andrade, A. L., Padruchny, D., Osipchik, S., Gehring, E., et al. (2018) · Addiction · doi:10.1111/add.14034 · Cited by 25
Vluggen, S., Candel, M., Hoving, C., Schaper, N. C., & de Vries, H. (2021) · Journal of Medical Internet Research · doi:10.2196/18524 · Cited by 26
Zainal, N. H., & Newman, M. G. (2023) · European Psychiatry · doi:10.1192/j.eurpsy.2023.2 · Cited by 28
“To this end, the SMP was intended to control for credibility and expectancy effects and regression to the mean and prevent inflated effect sizes as would occur with a no-treatment or waitlist control group [50].”
Bendtsen, M., & McCambridge, J. (2019) · JMIR Research Protocols · doi:10.2196/13119 · Cited by 25
“Attention to the design of control conditions in trials is underdeveloped [33-35].”
Self-citationSchuling, R., Huijbers, M. J., van Ravesteijn, H., Donders, R., Cillessen, L., Kuyken, W., & Speckens, A. E. M. (2020) · Journal of Affective Disorders · doi:10.1016/j.jad.2020.03.182 · Cited by 24
Klaperski, S., & Fuchs, R. (2021) · Mental health and physical activity · doi:10.1016/j.mhpa.2021.100408 · Cited by 25
Overcoming obstacles in the design of cancer anorexia/weight loss trials
Le‐Rademacher, J. G., Crawford, J., Evans, W. J., & Jatoi, A. (2017) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2017.06.008 · Cited by 23
Lindfors, E., Magnusson, T., & Ernberg, M. M. (2020) · Journal of Oral & Facial Pain and Headache · doi:10.11607/ofph.2670 · Cited by 23
Fineberg, N. A., Pellegrini, L., Clarke, A., Perera, U., Drummond, L. M., Albert, U., & Laws, K. R. (2022) · Comprehensive Psychiatry · doi:10.1016/j.comppsych.2022.152334 · Cited by 25
Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
Martínez‐López, E., Pérez-Guerrero, E. E., Torres-Carrillo, N. M., López-Quintero, A., Betancourt‐Núñez, A., & Gutiérrez-Hurtado, I. A. (2022) · Nutrients · doi:10.3390/nu14122365 · Cited by 24
“In the first instance, the waiting list control has an ethical advantage because all study subjects will receive the intervention; however, there is concern that using this type of control may overestimate the effects of the intervention, particularly in research whose goal is to modify behavior; in this sense, it has…”
BackgroundA randomized controlled trial on a self-guided Internet-based intervention for gambling problems
Bücker, L., Gehlenborg, J., Moritz, S., & Westermann, S. (2021) · Scientific Reports · doi:10.1038/s41598-021-92242-8 · Cited by 23
Ditton, E., Knott, B., Hodyl, N., Horton, G., Oldmeadow, C., Walker, F. R., & Nilsson, M. (2023) · JMIR Mental Health · doi:10.2196/42566 · Cited by 22
Müssener, U., Thomas, K., Linderoth, C., Leijon, M. E., & Bendtsen, M. (2018) · JMIR Human Factors · doi:10.2196/humanfactors.9641 · Cited by 21
“Concern regarding the ethics of assigning participants actively ready for change to control groups has been raised [22] and asking participants in control groups to wait to seek treatment may lessen their natural help-seeking behaviors [23].”
BackgroundVivas-Fernandez, M., Garcia-Lopez, L.-J., Piqueras, J. A., Muela-Martinez, J.-A., Canals-Sans, J., Espinosa-Fernandez, L., Jimenez-Vazquez, D., Diaz-Castela, M. D. M., Morales-Hidalgo, P., Rivera, M., et al. (2023) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/s13034-023-00616-9 · Cited by 20
“The use of waitlist control conditions (WLCs) in RCTs may also overestimate treatment effects and thus artificially inflate the effect sizes of prevention programs [1, 26, 31, 36, 74].”
BackgroundBendtsen, M., & McCambridge, J. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.03.008 · Cited by 20
Self-citationHughes, Z. D., Ball, L. J., Richardson, C., & Judge, J. (2023) · Psychonomic Bulletin & Review · doi:10.3758/s13423-023-02327-w · Cited by 23
“There are, however, concerns that employing wait-ing-list control designs may artificially inflate intervention effect estimates (Cunningham et al., 2013).”
BackgroundMethodInfluentialFrühauf, A., Sevecke, K., & Kopp, M. (2018) · Neuropsychiatrie · doi:10.1007/s40211-018-0283-0 · Cited by 19
Metadata
- Authors
- Cunningham, J. A., Kypri, K., & McCambridge, J.
- Affiliations
- Australian National University (AU)
- University of Newcastle Australia (AU)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Cunningham, John A
- Venue
- BMC Medical Research Methodology
- Published
- 2013-12
- Volume
- 13
- Issue
- 1
- Pages
- 150-150
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC4029562
- OpenAlex
- W2132268984
- Cited by
- 321
- References
- 40
- Citations by year
- 2026: 18 · 2025: 29 · 2024: 35 · 2023: 41 · 2022: 42 · 2021: 37 · 2020: 33 · 2019: 28 · 2018: 15 · 2017: 17 · 2016: 11 · 2015: 5 · 2014: 10
- FWCI
- 7.62
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Figshare (submittedVersion, cc-by)
- ANU Open Research (Australian National University) (submittedVersion, cc-by)
- NOVA (University of Newcastle Australia) (submittedVersion)
- Funders
- Wellcome Trust (WT086516MA)
- Medical Research Council
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- overestimation of treatment effects, brief intervention, problem drinking, personalized feedback, stages of change, alcohol consumption, drinking guidelines
- MeSH terms
- Adult, Alcohol Drinking, Behavior Therapy, Female, Humans, Male, Middle Aged, Research Design, Waiting Lists, Bias, Alcohol-Related Disorders
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