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

NCT05678972 | Completed

• 1 other identifier: SBRE-22-0350
• Study Type: interventional
• Target: 939
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness

Keywords

Mindfulness; Non-attachment; Internet-based mindfulness-based intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Mental Well-being

  at baseline, 4th, and 8th week

• Non-attachment

  at baseline, 4th, and 8th week

• Psychological distress

  at baseline, 4th, and 8th week

• Physical well-being

  at baseline, 4th, and 8th week

Study Arms (2)

Mindfulness group

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

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

Interventions

Self-help online mindfulness-based intervention OTHER

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.

Mindfulness group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Completion of mindfulness-related program/research in the past 3 months
• Have regular mindfulness practice

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychology

Hong Kong, Hong Kong

Location

Related Publications (8)

• 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.

  PMID: 31144205 BACKGROUND

• 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.

  PMID: 30508772 BACKGROUND

• 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.

  PMID: 36089936 BACKGROUND

• 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.

  PMID: 1028884 BACKGROUND

• 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.

  PMID: 1233242 BACKGROUND

• 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.

  PMID: 4762224 BACKGROUND

• 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.

  PMID: 16910215 BACKGROUND

• 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.

  PMID: 20155561 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

HK (1)