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NCT Number: NCT05678972

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

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.

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Key information

Conditions

Mindfulness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mindfulness and discernment

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Mental Well-being

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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