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

NCT ID: NCT05678972

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

939 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-04-30

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.

Detailed Description

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Conditions

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Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Waitlist control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Self-help online mindfulness-based intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Winnie W.S. MAK

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychology

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 31144205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30508772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36089936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1028884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1233242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4762224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16910215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20155561 (View on PubMed)

Other Identifiers

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SBRE-22-0350

Identifier Type: -

Identifier Source: org_study_id

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