Effects of a waiting list control design on alcohol consumption among online help-seekers:protocol for a randomised controlled trial

INTRODUCTION: Sparse attention has been given to the design of control conditions in trials, despite their important role as contrasts for novel treatments, and thus as a key determinant of effect sizes. This undermines valid inferences on effect estimates in trials, which are fundamentally comparative in nature. Such challenges to understanding also makes generalisation of effect estimates complex, for example, it may not be clear to what degree real-world alternatives to the novel treatments in pragmatic trials are similar to the control conditions studied. The present study aims to estimate the effects of being allocated to a waiting list control condition. METHODS AND ANALYSIS: Individuals searching online for help to reduce their drinking will be invited to take part in a study. Individuals aged 18 years or older, who in the past month consumed six or more drinks on one occasion, or consumed 10 or more drinks the past week, will be eligible to participate. Both groups will receive identical feedback and advice on behaviour change; however, one group will be informed that they have to wait 1 month for the intervention materials. One month postrandomisation, participants will receive an email with the follow-up questionnaire measuring the primary outcomes: (1) frequency of heavy episodic drinking (defined as at study entry) in the past month; and (2) overall past week alcohol consumption. Differences between groups will be analysed using negative binomial regression models estimated using Bayesian inference. Recruitment will begin in October 2021. A Bayesian group sequential design will be employed to determine when to end enrolment (expected to be between 500 and 1500 individuals). ETHICS AND DISSEMINATION: The study was approved by the Swedish Ethical Review Authority on 2021-01-25 (Dnr 2020-06267). Findings will be disseminated in open access peer-reviewed journals no later than 2023. TRIAL REGISTRATION TRIAL: ISRCTN14959594; Pre-results.