Effectiveness of a Brief Mindfulness-Based Intervention of “STOP" (Stop, Take a Breath, Observe, Proceed) Touching Your Face” During the COVID-19 Pandemic: Randomised Controlled Trial

Background: Avoid touching our eyes, nose, and mouth (T-zone) is one of recommended strategies to reduce the spread of the coronavirus disease 2019 (COVID-19) and other infectious diseases. However, face-touching is a frequent behaviour, and it is often done automatically without self-awareness. Raising self-awareness of habituated face-touching behaviour may help individuals to avoid face-touching by contaminated hands. Our aim was to evaluate whether mindfulness-based brief behaviour-change intervention (MBI) named “STOP (Stop, Take a Breath, Observe, Proceed) touching your face” can reduce face-touching behavior. Methods: In this online-based, two group, wait-list, randomized controlled trial, participants aged 18 years or more from general population in China were recruited via Chinese social media platforms. Eligible participants were randomly assigned in a 1:1 ratio to receive “STOP touching your face” intervention or control intervention. Those researchers who assessing outcomes were masked to group allocation. A 60-minute self-monitoring of face-touching behaviour was required to report in the pre- and post-intervention. Reduction of percentage of T-Zone touching was set as primary outcome, with reduction of face-touching frequency being a key secondary outcome. These outcomes were analysed in the intention-to-treat (ITT) basis with a complete case analysis (CCA). Safety was monitored in all randomly assigned participants. This trial is registered at ClinicalTrials.gov (Trial registration number: NCT04330352), and is completed. Findings: Between April 2, 2020 to July 2, 2020, 10194 participants were invited to the trial. Of these, we recruited and randomly assigned 1090 (10.7%) participants to the “STOP touching your face” intervention group (n=545) or to the wait-list control intervention (comparator) group (n=545) after reporting the first 60-minute self-monitoring of face-touching behaviour (pre-intervention). Among them, 71.6% (n=390) participants from the intervention group and 63.9% (n=348) from the control group reported the second 60-minute self-monitoring of face-touching behaviour (post-intervention). ITT analysis revealed that percentage of T-Zone touching was significantly reduced by 8.1% in the intervention group (from 81.1% to 73.0%, RR=0.901, OR=0.631, RD=-0.081, p=0.002), and insignificantly reduced by 0.6% in the control intervention (from 80.0% to 79.4%, p=0.821). Group comparison showed that fewer participants had T-Zone touching in the intervention group than that in the control group (73.0% vs 79.4%, RR=0.919, OR=0.700, RD=-0.064, p=0.015) after intervention, and that there was more reduction of T-Zone touching frequency in the intervention group than that in the control group (mean ± SD: 1.7 ± 5.13 vs 0.7 ± 3.98, Mean difference (95% CI): 1.03 (0.48 to 1.58), p<0.001, Cohen's d=-0.218). The above results were further confirmed by CCA. Compared with older individuals (≥30 years old), young adults (18–29 years old) have twice risk of having T-Zone touching behaviour (OR=2.029, 95% CI=1.145 to 3.597, p=0.015), and younger participants reduced face-touching frequency more than their older counterparts (mean ± SD: 9.9 ± 14.24 vs 3.6 ± 11.25, Mean difference (95% CI)=6.270 (3.615 to 8.924), p<0.001, Cohen's d=-0.47). Interpretation This trial is the first to evaluate the efficacy of “STOP touching your face” intervention to reduce face-touching behaviour during the outbreak of COVID-19. The findings of significantly reduced T-Zone touching behaviour in the intervention group supports the widely dissemination of this brief and simple mindfulness-based behaviour-change intervention to low the risk for the COVID-19 and other hand-to face-touching infectious diseases.Trial registration number: NCT04330352Trial Registration. Funding: Zhejiang University, number (2020XGZX046). Declaration of Interest: We declare no competing interests.Ethical Approval: The trial was approved by The Ethics Committee of Sir Run Run Shaw hospital, an affiliate of Zhejiang University, Medical College (NO. 20200401-32).