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Open Access Highly Accessed Research article

Exploratory randomized controlled trial evaluating the impact of a waiting list control design

John A Cunningham12*, Kypros Kypri3 and Jim McCambridge4

Author Affiliations

1 Centre for Mental Health Research, the Australian National University, Canberra, Australia

2 Centre for Addiction and Mental Health, Toronto, Canada

3 Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia

4 Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK

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BMC Medical Research Methodology 2013, 13:150  doi:10.1186/1471-2288-13-150

Published: 6 December 2013

Abstract

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 (Nā€‰=ā€‰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.

Keywords:
Randomized controlled trials; Research methods; Waiting list control design; Alternate explanation; Alcohol; Brief intervention