Mindful Breathing Using EMA and and Actigraphy: A Pilot Study

Mindfulness Clinical Trial

Official title:

Positive Spiral of Mindfulness in Mindful Breathing: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment and Actigraphy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718753
• Other study ID #: PSY013
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mindfulness
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ecological momentary assessment (EMA) - Mindful Attention Awareness Scale (MAAS)	An in-house smartphone application will be developed and installed in the participant's smartphones for recording the participants' mindfulness at baseline once and 4 times a day over 7 consecutive days. MAAS is a 15-item scale widely used to assess the level of mindfulness, which scores each of the 15 statements as "1" (almost always) to "6" (almost never). The computed score is calculated by averaging the 15 scores. State MAAS is a 5-item scale developed from MAAS, which scores each of the 5 statements as "0" (almost always) to "6" (almost never). The MAAS will be used in baseline and immediately post-intervention while the state MAAS will be used in baseline and intervention/ waitlist period via EMA.	Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
Primary	Change in EMA - Positive and Negative Affect Scale (PANAS)	An in-house smartphone application will be developed and installed in the participant's smartphones for recording the participants' positive and negative affect at baseline once and 4 times a day over 7 consecutive days. PANAS is a 20-item five-point Likert scale widely used to assess positive and negative mood or emotion. This scale consists of 10 items measuring positive affect and 10 items measuring negative affect.	Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
Secondary	Change in Depression Anxiety Stress Scales (DASS-21)	DASS-21 is a 21-item scale, comprises three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week.	Baseline and immediately post-intervention (7days)
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a widely used 24-item scale used to access the sleep quality and disturbances over a 1-month interval. The 19 self-rated questions will be used and modified for a 1-week time interval in this study.	Baseline and immediately post-intervention (7days)
Secondary	Self-developed Survey	The self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence).	Baseline
Secondary	Record of mindful breathing	The record will collect the time when the participant practice mindful breathing.	Intervention period (once a day over 7days)
Secondary	Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep-onset latency (SOL)	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 7 consecutive days, SOL is one of the sleep parameters which will be measured by Actigraphy.	Baseline and intervention/ waitlist period (7 days)
Secondary	Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - wake after sleep onset (WASO)	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 7 consecutive days, WASO is one of the sleep parameters which will be measured by Actigraphy.	Baseline and intervention/ waitlist period (7 days)
Secondary	Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total wake time (TWT)	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 7 consecutive days, TWT is one of the sleep parameters which will be measured by Actigraphy.	Baseline and intervention/ waitlist period (7 days)
Secondary	Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total sleep time (TST)	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 7 consecutive days, TST is one of the sleep parameters which will be measured by Actigraphy.	Baseline and intervention/ waitlist period (7 days)
Secondary	Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep efficiency (SE)	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 7 consecutive days, SE is one of the sleep parameters which will be measured by Actigraphy.	Baseline and intervention/ waitlist period (7 days)
Secondary	Change in Polar H10 heart rate sensor (Polar Electro, Inc.) - heart rate variability (HRV)	Participants will be instructed to wear a wrist-worn actigraphy device and a heart rate sensor strapped around their chest to record their physiological patterns for 7 consecutive days. Heart rate variability (HRV) will be measured by the sensor to indicate stress level.	Baseline and intervention/ waitlist period (7 days)