Mindfulness-based "STOP (Stop, Take a B… | Clinical Trial

Key information

Conditions

Face-touching Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yanhui Liao

Hangzhou, Zhejiang, 310016, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Under 18 years of age
Unable to access online services
Unable to read and write in Chinese

Treatment and study plan

Mindfulness-based "STOP touching your face" practice

Behavioral

Remind yourself to STOP. Whatever you are doing in this moment (e.g. touching your month, pinching your nose, rubbing your eyes, resting your chin on your hands), pause for a minute. 2. Take a deep breath. This reconnects you with your body. Pay attention to your breathing and just allow yourself to continue to breathe normally and naturally. 3. Observe what is happening for you in this moment-including thoughts, feelings, and emotions (e.g. feel distracted, anxious or nervous?). What do you notice in your body (e.g. feel itchy or tingling on any part of your face)? You can be aware of anything: posture, sensations, tension in your body, or, once again, your breath. You might notice the sound around you. You might even notice your thoughts or emotions. 4. Proceed with whatever you were doing before you came to a STOP or something that you want to do in the moment (e.g. proceed with touching your face, or stop face-touching and take an alternative behavior).

Primary outcomes

Reduction of frequency of face-touching behavior

Time frame: 2 hours

This will be calculated as the total times of face-touching (including the eyes, nose, mouth, ears, cheeks, chin, neck, forehead, hair) during a 60-minute period before the intervention minus the total times of face-touching after the intervention.

Secondary outcomes

Reduction of percentage of participants touching their faces

Time frame: 2 hours

This will be calculated as the percentage of participants touching their faces (including any of the following areas: the eyes, nose, mouth, ears, cheeks, chin, neck, forehead, hair) during a 60-minute period before the intervention minus the percentage of participants touching their faces after the intervention.
Five Facet Mindfulness Questionnaire (FFMQ)

Time frame: 2 hours

To measure the correlation between the psychological traits of mindfulness (measured by FFMQ) and face-touching behavior. The self-report scale of FFMQ is currently the most frequently used mindfulness questionnaire to measure changes in participant's tendency to be mindful in daily life by the following five related facets: observing(noticing, attending to sensations, perceptions, thoughts, feelings; 8 items), describing (labeling feelings, thoughts with words), acting with awareness (automatic pilot, concentration, non-distraction), non-judging internal experience, and non-reactivity to internal experience. Participants will be asked to what extent each of the statements are true of them. Each item is on a 1 to 5 Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). The factor structure of the short version (FFMQ-15) will be used in this study, which has been consistent with that of the FFMQ-39.
The Edinburgh Handedness Inventory (EHI)

Time frame: 2 hours

To measure the differences of face-touching behavior between left-handers and right-handers. EHI is the most widely used 10-item self-report inventory to assess handedness. It is comprised of the following 10 activities: (1) writing, (2) drawing, (3) throwing, (4) using scissors, (5) a toothbrush (6) knife (without fork), (7) spoon, and such activities involving both hands as (8) using a broom (upper hand), (9) striking a match, and (10) unscrewing the lid of a bottle. To complete the EHI, one or two check marks are placed under "left (L)" or "right (R)" columns, indicating strength of preference for each activity. Participants will be asked write "2", "1" or "0" in the appropriate corresponding column. If the preference is very strong that they would never try to use the other hand unless absolutely forced to, then they will mark this column as "2" and the other column as "0". If they are really indifferent, they will mark it as "1" in both columns.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

"STOP Touching Your Face": a Randomized Controlled Trial of Brief Mindfulness-based Intervention

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 1, 2020
Registry last updated: Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.