Brief mindfulness-based intervention of 'STOP (Stop, Take a Breath, Observe, Proceed) touching your face': a study protocol of a randomised controlled trial.

INTRODUCTION

Face-touching behaviour often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behaviour disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named 'STOP (Stop, Take a Breath, Observe, Proceed) touching your face' in reducing face-touching behaviour.

METHODS AND ANALYSIS

This will be an online-based, randomised, controlled, trial. We will recruit 1000 participants, and will randomise and allocate participants 1:1 to the 'STOP touching your face' (both 750-word text and 5 min audio description by online) intervention group (n=500) and the wait-list control group (n=500). All participants will be asked to monitor and record their face-touching behaviour during a 60 min period before and after the intervention. Primary outcome will be the efficacy of short-term mindfulness-based 'STOP touching your face' intervention for reducing the frequency of face-touching. The secondary outcomes will be percentage of participants touching their faces; the correlation between the psychological traits of mindfulness and face-touching behaviour; and the differences of face-touching behaviour between left-handers and right-handers. Analysis of covariance, regression analysis, χ test, t-test, Pearson's correlations will be applied in data analysis. We will recruit 1000 participants from April to July 2020 or until the recruitment process is complete. The follow-up will be completed in July 2020. We expect all trial results to be available by the end of July 2020.

ETHICS AND DISSEMINATION

The study protocol has been approved by the Ethics Committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (No. 20200401-32). Study results will be disseminated via social media and peer-reviewed publications.

TRIAL REGISTRATION NUMBER

NCT04330352.