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

Not Applicable

Completed

• Conditions: Mindfulness
• Interventions: Other: Self-help online mindfulness-based intervention

• Registration Number: NCT05678972
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 939

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness group	Self-help online mindfulness-based intervention	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).

Primary Outcome Measures

Name	Time	Method
Mindfulness and discernment	8th week	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).

Secondary Outcome Measures

Name	Time	Method
Non-attachment	at baseline, 4th, and 8th week	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.
Physical well-being	at baseline, 4th, and 8th week	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.
Mental Well-being	at baseline, 4th, and 8th week	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).
Psychological distress	at baseline, 4th, and 8th week	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).

Trial Locations

Locations (1)

Department of Psychology; 🇭🇰 Hong Kong, Hong Kong