Mindful Breathing Using EMA and and Actigraphy: A Pilot Study
Primary Purpose
Mindfulness
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindful breathing intervention
Sponsored by
About this trial
This is an interventional prevention trial for Mindfulness focused on measuring Mindfulness, Mindful breathing, Positive spiral
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents aged ≥ 18 years and ≤ 65 years;
- Cantonese language fluency; and
- A willingness to provide informed consent and comply with the study protocol.
Exclusion Criteria:
- Major medical or neurocognitive disorders that make participation infeasible;
- 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);
- Cardiovascular diseases that affect the measure of heart rate variability (HRV); and
- Using medication or psychotherapy for any psychological disorder.
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindful Breathing Group
Waitlist Control Group
Arm Description
Mindful breathing intervention which has been used in mindfulness-based interventions
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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).
Record of mindful breathing
The record will collect the time when the participant practice mindful breathing.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04718753
First Posted
January 14, 2021
Last Updated
August 11, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04718753
Brief Title
Mindful Breathing Using EMA and and Actigraphy: A Pilot Study
Official Title
Positive Spiral of Mindfulness in Mindful Breathing: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment and Actigraphy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness
Keywords
Mindfulness, Mindful breathing, Positive spiral
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindful Breathing Group
Arm Type
Experimental
Arm Description
Mindful breathing intervention which has been used in mindfulness-based interventions
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Intervention Type
Behavioral
Intervention Name(s)
Mindful breathing intervention
Intervention Description
Mindful breathing intervention audio, which is used in mindfulness-based interventions, will be sent to the participants once per day.
Primary Outcome Measure Information:
Title
Change in Ecological momentary assessment (EMA) - Mindful Attention Awareness Scale (MAAS)
Description
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.
Time Frame
Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
Title
Change in EMA - Positive and Negative Affect Scale (PANAS)
Description
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.
Time Frame
Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
Secondary Outcome Measure Information:
Title
Change in Depression Anxiety Stress Scales (DASS-21)
Description
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.
Time Frame
Baseline and immediately post-intervention (7days)
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline and immediately post-intervention (7days)
Title
Self-developed Survey
Description
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).
Time Frame
Baseline
Title
Record of mindful breathing
Description
The record will collect the time when the participant practice mindful breathing.
Time Frame
Intervention period (once a day over 7days)
Title
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep-onset latency (SOL)
Description
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.
Time Frame
Baseline and intervention/ waitlist period (7 days)
Title
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - wake after sleep onset (WASO)
Description
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.
Time Frame
Baseline and intervention/ waitlist period (7 days)
Title
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total wake time (TWT)
Description
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.
Time Frame
Baseline and intervention/ waitlist period (7 days)
Title
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total sleep time (TST)
Description
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.
Time Frame
Baseline and intervention/ waitlist period (7 days)
Title
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep efficiency (SE)
Description
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.
Time Frame
Baseline and intervention/ waitlist period (7 days)
Title
Change in Polar H10 heart rate sensor (Polar Electro, Inc.) - heart rate variability (HRV)
Description
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.
Time Frame
Baseline and intervention/ waitlist period (7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hong Kong residents aged ≥ 18 years and ≤ 65 years;
Cantonese language fluency; and
A willingness to provide informed consent and comply with the study protocol.
Exclusion Criteria:
Major medical or neurocognitive disorders that make participation infeasible;
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);
Cardiovascular diseases that affect the measure of heart rate variability (HRV); and
Using medication or psychotherapy for any psychological disorder.
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
12. IPD Sharing Statement
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Mindful Breathing Using EMA and and Actigraphy: A Pilot Study
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