Clinical trial NCT04330352: Mindfulness-based "STOP (Stop, Take a Breath, Observe, Proceed) Touching Your Face" Intervention
Official title: "STOP Touching Your Face": a Randomized Controlled Trial of Brief Mindfulness-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face-touching Behavior
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 1094
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-blind, randomized, controlled, trial is to assess the efficasy of a brief mindfulness-based "STOP touching your face" training program to reduce or avoid face-touching to low people's chances of catching infectious diseases like COVID-19.

Detailed description: Background Face-touching behavior 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 behavior 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 behavior.

Methods This will be a single-blind, randomized, controlled, trial. We will recruit 1,000 participants, and will randomize and allocate participants 1:1 to the "STOP touching your face" intervention group (n=500) and the control group (n=500). All participants will be asked to monitor and record their face-touching behavior. The intervention group will receive the brief online mindfulness-based "STOP touching your face" program, and the control group will receive control 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 the reduction of the duration of face-touching after intervention; the correlation between the psychological traits of mindfulness and face-touching behavior; and the differences of face-touching behavior between left-handers and right-handers. We will recruit 1000 participants from April to June 2020 or until the recruitment process is complete. The follow-up will be completed in June 2020. We expect all trial results to be available by the end of June 2020.

Discussion This is the first RCT to evaluate the efficacy of brief mindfulness intervention to reduce face-touching behavior. We expect that "STOP touching your face" has a significantly greater reduction the frequency of face-touching behavior than the control intervention. As "STOP touching your face" is a brief and simple skill, the public health impact of its expansion world-wide could be enormous, helping us to manage any face-touching spread infectious diseases, like Coronavirus disease 2019 (COVID-19).

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Being able to access online services
3. Being able to read and write in Chinese
4. Expressing an interest in participant this study
5. Willing to provide informed consent to participate in the study

Exclusion Criteria:

1. Under 18 years of age
2. Unable to access online services
3. Unable to read and write in Chinese

Primary outcomes:
measure: Reduction of frequency of face-touching behavior
timeFrame: 2 hours
Secondary outcomes:
measure: Reduction of percentage of participants touching their faces
timeFrame: 2 hours
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 2 hours
measure: The Edinburgh Handedness Inventory (EHI)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yanhui Liao
state: Zhejiang
Study officials:
References:
citation: Liao Y, Wang L, Luo T, Wu S, Wu Z, Chen J, Pan C, Wang Y, Liu Y, Luo Q, Guo X, Xie L, Zhou J, Chen W, Tang J. Brief mindfulness-based intervention of 'STOP (Stop, Take a Breath, Observe, Proceed) touching your face': a study protocol of a randomised controlled trial. BMJ Open. 2020 Nov 24;10(11):e041364. doi: 10.1136/bmjopen-2020-041364.