Clinical trial NCT05678972: Pause and Breathe: Online Self-Help Mindfulness-Based Intervention: Investigation of Its Efficacy and Mechanism of Change
Official title: Pause and Breathe: Online Self-Help Mindfulness-Based Intervention: Investigation of Its Efficacy and Mechanism of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Keywords: Mindfulness
Non-attachment
Internet-based mindfulness-based intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 939
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mindfulness and discernment
timeFrame: at baseline
measure: Mindfulness and discernment
timeFrame: 4th week
measure: Mindfulness and discernment
timeFrame: 8th week
Secondary outcomes:
measure: Mental Well-being
timeFrame: at baseline, 4th, and 8th week
measure: Non-attachment
timeFrame: at baseline, 4th, and 8th week
measure: Psychological distress
timeFrame: at baseline, 4th, and 8th week
measure: Physical well-being
timeFrame: at baseline, 4th, and 8th week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychology
Study officials:
References:
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