Clinical trial NCT04718753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Keywords: Mindfulness
Mindful breathing
Positive spiral
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Ecological momentary assessment (EMA) - Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
measure: Change in EMA - Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline (1day), intervention/ waitlist period (four times per day over 7days) and immediately post-intervention (7days)
Secondary outcomes:
measure: Change in Depression Anxiety Stress Scales (DASS-21)
timeFrame: Baseline and immediately post-intervention (7days)
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and immediately post-intervention (7days)
measure: Self-developed Survey
timeFrame: Baseline
measure: Record of mindful breathing
timeFrame: Intervention period (once a day over 7days)
measure: Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep-onset latency (SOL)
timeFrame: Baseline and intervention/ waitlist period (7 days)
measure: Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - wake after sleep onset (WASO)
timeFrame: Baseline and intervention/ waitlist period (7 days)
measure: Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total wake time (TWT)
timeFrame: Baseline and intervention/ waitlist period (7 days)
measure: Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - total sleep time (TST)
timeFrame: Baseline and intervention/ waitlist period (7 days)
measure: Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep efficiency (SE)
timeFrame: Baseline and intervention/ waitlist period (7 days)
measure: Change in Polar H10 heart rate sensor (Polar Electro, Inc.) - heart rate variability (HRV)
timeFrame: Baseline and intervention/ waitlist period (7 days)
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: