Mindful Breathing Using EMA and and Actigraphy: A Pilot Study

NCT ID: NCT04718753

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2021-05-31

Brief Summary

This study will examine the effect of mindful breathing and the mechanism of positive spirals of mindfulness using ecological momentary assessment (EMA) and actigraphy. Previous studies have shown a positive spiral between state mindfulness and positive affect (Du, An, Ding, Zhang, & Xu, 2018). The mindful coping model (Garland, Gaylord, & Fredrickson, 2011) suggested that the state of mindfulness can lead to reappraisal and reframing of their stressful circumstances which further lead to positive emotion and reduced stress. These positive effects will affect the next cycle and hence form a positive spiral. Since mindful breathing was an effective practice for immediate decentering (Feldman, Greeson, & Senville, 2010), it will be used as the manipulation of state mindfulness. Besides, there is very limited research on the associations between these constructs using EMA and actigraphy. Therefore, this study will explore this association by manipulating the state of mindfulness with mindful breathing using EMA.

Detailed Description

This proposed study will be a randomized control trial which studies the mechanism of positive spirals of mindfulness in mindful breathing. Potential participants will be recruited from the community through posters, social media sites and/or emails. About 30 eligible participants will be recruited after an online screening (with phone support). Prior to all study procedures, the research purpose and data collection procedure will be given to the participants and an online informed consent will be obtained from them.

In this study, participants will be randomly assigned to either the mindful breathing group (intervention group) or the waitlist group (control group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary.

All participants will be requested to wear an actigraphy device (ActiGraph GT9X link) connected to a heart rate sensor (Polar H10) for 8 consecutive days, for recording their physiological data including HRV and activity level. Ecological momentary assessment (EMA) will also be used. A smartphone application will be developed and installed in the participants' smartphones. The app will prompt the participants, 4 times each day (9 a.m., 1 p.m., 5 p.m. and 9 p.m.), to fill in a self-report questionnaire concerning mood. Besides that, participants have to complete an assessment at baseline and immediate post-intervention assessments.

Participants in treatment group will receive mindful breathing instructions daily (at 9 a.m. after completing the EMA questionnaires). They will be asked to perform a 10-minute mindful breathing exercise based on an audio. After that, they will submit a simple record indicating the time they have completed the exercise. Meanwhile, participants in the waitlist condition will not receive the recording during the study. However, the same set of mindful breathing instruction audio will be sent to the waitlist group after the study.

Conditions

Mindfulness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mindful Breathing Group

Mindful breathing intervention which has been used in mindfulness-based interventions

Group Type: EXPERIMENTAL

Mindful breathing intervention

Intervention Type: BEHAVIORAL

Mindful breathing intervention audio, which is used in mindfulness-based interventions, will be sent to the participants once per day.

Waitlist Control Group

Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindful breathing intervention

Mindful breathing intervention audio, which is used in mindfulness-based interventions, will be sent to the participants once per day.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hong Kong residents aged ≥ 18 years and ≤ 65 years;

2. Cantonese language fluency; and

3. A willingness to provide informed consent and comply with the study protocol.

Exclusion Criteria

1. Major medical or neurocognitive disorders that make participation infeasible;

2. Having psychiatric disorders based on General Health Questionnaire (GHQ-28) score > 11 or having suicidal ideation based on a positive answer to question 27 and 28 (referral information to professional services will be provided to those who endorsed items on suicidal ideation);

3. Cardiovascular diseases that affect the measure of heart rate variability (HRV); and

4. Using medication or psychotherapy for any psychological disorder.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

PSY013

Identifier Type: -

Identifier Source: org_study_id