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

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678972
• Other study ID #: SBRE-22-0350
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 939
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Psychology	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (8)

Folstein MF, Luria R. Reliability, validity, and clinical application of the Visual Analogue Mood Scale. Psychol Med. 1973 Nov;3(4):479-86. doi: 10.1017/s0033291700054283. No abstract available. — View Citation

Joyce CR, Zutshi DW, Hrubes V, Mason RM. Comparison of fixed interval and visual analogue scales for rating chronic pain. Eur J Clin Pharmacol. 1975 Aug 14;8(6):415-20. doi: 10.1007/BF00562315. — View Citation

O'Connor PJ. Mental energy: Assessing the mood dimension. Nutr Rev. 2006 Jul;64(7 Pt 2):S7-9. doi: 10.1111/j.1753-4887.2006.tb00256.x. — View Citation

Sahdra BK, Shaver PR, Brown KW. A scale to measure nonattachment: a Buddhist complement to Western research on attachment and adaptive functioning. J Pers Assess. 2010 Mar;92(2):116-27. doi: 10.1080/00223890903425960. — View Citation

Schneider D, Appleton L. A reason for visit classification system for ambulatory care. Med Rec News. 1976 Oct;47(5):59-66, 68. No abstract available. — View Citation

Staples LG, Dear BF, Gandy M, Fogliati V, Fogliati R, Karin E, Nielssen O, Titov N. Psychometric properties and clinical utility of brief measures of depression, anxiety, and general distress: The PHQ-2, GAD-2, and K-6. Gen Hosp Psychiatry. 2019 Jan-Feb;56:13-18. doi: 10.1016/j.genhosppsych.2018.11.003. Epub 2018 Nov 22. — View Citation

Sun Y, Luk TT, Wang MP, Shen C, Ho SY, Viswanath K, Chan SSC, Lam TH. The reliability and validity of the Chinese Short Warwick-Edinburgh Mental Well-being Scale in the general population of Hong Kong. Qual Life Res. 2019 Oct;28(10):2813-2820. doi: 10.1007/s11136-019-02218-5. Epub 2019 May 29. — View Citation

Tsoi EWS, Tong ACY, Mak WWS. Nonattachment at Work on Well-being Among Working Adults in Hong Kong. Mindfulness (N Y). 2022;13(10):2461-2472. doi: 10.1007/s12671-022-01971-y. Epub 2022 Sep 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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