MindfulnessNCT04718753
Mindful Breathing Using EMA and and Actigraphy: A Pilot Study
A study testing Mindful breathing intervention in people with Mindfulness, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Mindful breathing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Feb 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Spiral of Mindfulness in Mindful Breathing: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment and Actigraphy
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.
Read the 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
- Being tested
- Mindful breathing intervention
- Keywords
- Mindfulness, Mindful breathing, Positive spiral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful breathing interventionBehavioural
Mindful breathing intervention audio, which is used in mindfulness-based interventions, will be sent to the participants once per day.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Breathing Group | Experimental | Mindful breathing intervention which has been used in mindfulness-based interventions Receives: Behavioral: Mindful breathing intervention |
| Waitlist Control Group | No intervention | Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
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.
Measured: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
Secondary outcomes (10)
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.
Measured: Baseline and immediately post-intervention (7days)
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.
Measured: Baseline and immediately post-intervention (7days)
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).
Measured: Baseline
Record of mindful breathing
The record will collect the time when the participant practice mindful breathing.
Measured: Intervention period (once a day over 7days)
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.
Measured: Baseline and intervention/ waitlist period (7 days)
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.
Measured: Baseline and intervention/ waitlist period (7 days)
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.
Measured: Baseline and intervention/ waitlist period (7 days)
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.
Measured: Baseline and intervention/ waitlist period (7 days)
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.
Measured: Baseline and intervention/ waitlist period (7 days)
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.
Measured: Baseline and intervention/ waitlist period (7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start24 Feb 2021
- Primary completion30 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718753
- Sponsor's protocol ID
- PSY013
- Status last verified
- Aug 2021
- First submitted
- 14 Jan 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Spiral of Mindfulness in Mindful Breathing: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment and Actigraphy
- ClinicalTrials.gov ID
- NCT04718753
- Acronym / sponsor ID
- PSY013
- Conditions
- Mindfulness
- Keywords
- Mindfulness, Mindful breathing, Positive spiral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Breathing Group | Experimental | Behavioral: Mindful breathing interventionMindful breathing intervention which has been used in mindfulness-based interventions |
| Waitlist Control Group | No intervention | –Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful breathing interventionMindful breathing intervention audio, which is used in mindfulness-based interventions, will be sent to the participants once per day. | Behavioural | Mindful Breathing Group |
Primary outcome
Change in Ecological momentary assessment (EMA) - Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
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)
Time frame: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
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.
10 secondary outcomes
Change in Depression Anxiety Stress Scales (DASS-21)
Time frame: Baseline and immediately post-intervention (7days)
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and immediately post-intervention (7days)
Self-developed Survey
Time frame: Baseline
Record of mindful breathing
Time frame: Intervention period (once a day over 7days)
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep-onset latency (SOL)
Time frame: Baseline and intervention/ waitlist period (7 days)
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - wake after sleep onset (WASO)
Time frame: Baseline and intervention/ waitlist period (7 days)
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total wake time (TWT)
Time frame: Baseline and intervention/ waitlist period (7 days)
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total sleep time (TST)
Time frame: Baseline and intervention/ waitlist period (7 days)
Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep efficiency (SE)
Time frame: Baseline and intervention/ waitlist period (7 days)
Change in Polar H10 heart rate sensor (Polar Electro, Inc.) - heart rate variability (HRV)
Time frame: Baseline and intervention/ waitlist period (7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful breathing intervention in people with Mindfulness, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ecological momentary assessment (EMA) - Mindful Attention Awareness Scale (MAAS) (time frame: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.