Pause and Breathe: Online Self-Help Mindfulness-Based Intervention: Investigation of Its Efficacy and Mechanism of Change

Study Overview
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Brief Summary
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The current study aims to evaluate the effectiveness of a 4-week self-help online mindfulness-based intervention on mental and physical well-being in comparison to the waitlist control group. This study can provide support to the utility of self-help online mindfulness-based intervention, which may advance our understanding of the causal pathways between mindfulness-based intervention and well-being and guide future research. It is hypothesized that participants in the experimental condition will show better mental well-being, physical well-being, and better improvement in mindfulness and related attributes compared with participants in the control condition. Upon completing the screening and pre-evaluation questionnaire, participants will be randomly assigned to either mindfulness group or waitlist control group. They will complete three sets of questionnaires in total which will be administered before the intervention (pre-test assessment), right after the 4-week intervention (post-test assessment), and four weeks after the intervention (follow-up assessment), respectively. In the experimental group, participants in the mindfulness group will engage in a 4-week online mindfulness course. The self-help online mindfulness course includes education about mindfulness, guided meditations (e.g., mindful breathing, mindful eating, mindful walking, body scan, acceptance, choiceless awareness and disengaging from thoughts exercise), and guidance on using informal mindfulness skills in day-to-day life. Readings, audio and videos are included to explain the concept of mindfulness and overcome common difficulties associated with mindfulness practice. In the waitlist control group, participants are to refrain from access the online course until they finished the follow-up questionnaire. All participants will be able to access the materials in an online platform after they have completed the research.

Official Title
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Pause and Breathe: Online Self-Help Mindfulness-Based Intervention: Investigation of Its Efficacy and Mechanism of Change

Conditions
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Mindfulness

Intervention / Treatment
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* Other: Self-help online mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be over age 18 Have access to computer and mobile phone (since this is an internet-based study) Have ability to read and comprehend Cantonese Exclusion Criteria: Completion of mindfulness-related program/research in the past 3 months Have regular mindfulness practice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness group<br>Participants in the mindfulness group will be expected to complete a self-help online mindfulness-based intervention, delivered over a 4-week period via an e-learning mental health platform. They will be assessed at three different time points: (1) before the intervention (pre-test assessment), (2) right after the 4-week intervention (post-test assessment), and (3) four weeks after the intervention (follow-up assessment). | Other: Self-help online mindfulness-based intervention<br>* This self-help online mindfulness-based intervention is comprised of four weekly modules on education about mindfulness, guided meditations (e.g., mindful breathing, mindful eating, mindful walking, body scan, acceptance, choiceless awareness and disengaging from thoughts exercise), and guidance on using informal mindfulness skills in day-to-day life. Readings, audio and videos are included to explain the concept of mindfulness and overcome common difficulties associated with mindfulness practice. Participants will be asked to meditate daily and complete a daily log on their mindfulness practice during this 8-week period.<br>|
| No Intervention: Waitlist control group<br>The participants in waitlist control group will be offered access to the online mindfulness course after the study has ended. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindfulness and discernment | Mindfulness and discernment will be assessed using the Mindfulness-Discernment Scale. Ten items capture participants' levels of mindfulness and fourteen items reflect participants' levels of discernment. Items are rated on a scale ranging from 1 (Never) to 6 (Always). | at baseline | 
| Mindfulness and discernment | Mindfulness and discernment will be assessed using the Mindfulness-Discernment Scale. Ten items capture participants' levels of mindfulness and fourteen items reflect participants' levels of discernment. Items are rated on a scale ranging from 1 (Never) to 6 (Always). | 4th week | 
| Mindfulness and discernment | Mindfulness and discernment will be assessed using the Mindfulness-Discernment Scale. Ten items capture participants' levels of mindfulness and fourteen items reflect participants' levels of discernment. Items are rated on a scale ranging from 1 (Never) to 6 (Always). | 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Well-being | The Warwick Edinburgh Mental Well-being Scale (Tennant et al, 2007). The WEMWBS is a measure of mental well-being focusing entirely on positive aspects of mental health. It is a 7-item measure, using a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). The Warwick Edinburgh Mental Well-being Scale (Tennant et al, 2007) WEMWBS is a measure of mental well-being focusing entirely on positive aspects of mental health. It is a 7-item measure, using a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). | at baseline, 4th, and 8th week | 
| Non-attachment | The Nonattachment Scale-Short Form (Chio, Lai, & Mak, 2018) was used to measure nonattachment. Participants rated the items from 1 (disagree strongly) to 6 (agree strongly). Excellent internal consistency was demonstrated in the previous studies. | at baseline, 4th, and 8th week | 
| Psychological distress | Psychological distress will be measured by the 6-item Kessler Psychological Distress Scale, which is a well-established measure on psychological distress that asks about a person's emotional state from 0 (none of the time) to 4 (all of the time). | at baseline, 4th, and 8th week | 
| Physical well-being | Visual Analogue Scale-Pain (VAS-P), Visual Analogue Scale-Energy (VAS-E), and Sleep disturbance subscale of the Medical Outcomes Study Sleep Measure (MOS-Sleep) will be used to assess participants' physical well-being. Participants will rate items related to their subjective energy level , pain and sleep. | at baseline, 4th, and 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Non-attachment, Internet-based mindfulness-based intervention