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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05678972
Collaborator
(none)
1,500
1
2
12
125.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self-help online mindfulness-based intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pause and Breathe: Online Self-Help Mindfulness-Based Intervention: Investigation of Its Efficacy and Mechanism of Change
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness group

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
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.

No Intervention: Waitlist control group

The participants in waitlist control group will be offered access to the online mindfulness course after the study has ended.

Outcome Measures

Primary Outcome Measures

  1. Mindfulness and discernment [at baseline]

    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).

  2. Mindfulness and discernment [4th 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).

  3. 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

  1. 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).

  2. 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.

  3. 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).

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychology Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Winnie W.S. MAK, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05678972
Other Study ID Numbers:
  • SBRE-22-0350
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Winnie W.S. MAK, Professor, Chinese University of Hong Kong

Study Results

No Results Posted as of Jan 10, 2023