"STOP Touching Your Face": a Randomized Controlled Trial of Brief Mindfulness-based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,094
- 试验地点
- 1
- 主要终点
- Reduction of frequency of face-touching behavior
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Under 18 years of age
- •Unable to access online services
- •Unable to read and write in Chinese
研究组 & 干预措施
Mindfulness-based "STOP touching your face" intervention
Eligibility participants who are allocated to the intervention group will be required to find a time to monitor and record their behavior of hand-to-face contacts, including the frequency and length (in second) of face-touching in any of the mucosal area (eyes, nose, mouth) and nonmucosal area (ears, cheeks, chin, neck, forehead, hair) during a 60-minute period. Then, they will receive the online mindfulness-based "STOP touching your face" program. Each participant will be required to practice this technique until they feel confident and natural. The systematic review showed the efficacy of single session of brief MBIs, the average length was 15 minutes, ranged from less than 5 to 25 min. Thus, the requirement practice time will be at least 15 minutes (excluding the time of reading the text and the first time of listening to the audio). Later (at least 1-hour interval), they will be asked to self-monitor and report their one-hour face-touching behavior again.
干预措施: Mindfulness-based "STOP touching your face" practice (Behavioral)
Contron information intervention
Participants who allocate to the control group will only receive information to thank them and encourage them to complete the study. They will receive "STOP touching your face" program after the end of this study. The repeat measurement of the face-touching behavior will be in at least 1-hour interval.
结局指标
主要结局
Reduction of frequency of face-touching behavior
时间窗: 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.
次要结局
- Five Facet Mindfulness Questionnaire (FFMQ)(2 hours)
- Reduction of percentage of participants touching their faces(2 hours)
- The Edinburgh Handedness Inventory (EHI)(2 hours)
研究者
Yanhui Liao
Psychiatrist
Sir Run Run Shaw Hospital