Mindful Breathing Using EMA and and Actigraphy: A Pilot Study

NCT04718753 | Completed

• 1 other identifier: PSY013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness

Keywords

Mindfulness; Mindful breathing; Positive spiral

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• Change in Depression Anxiety Stress Scales (DASS-21)

  Baseline and immediately post-intervention (7days)

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline and immediately post-intervention (7days)

• Self-developed Survey

  Baseline

• Record of mindful breathing

  Intervention period (once a day over 7days)

• Change in Actigraphy (Actigraph GT9X Link; USA Philips Respironics Inc.) - sleep-onset latency (SOL)

  Baseline and intervention/ waitlist period (7 days)

Study Arms (2)

Mindful Breathing Group

EXPERIMENTAL

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

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

Interventions

Mindful breathing intervention BEHAVIORAL

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

Mindful Breathing Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: February 24, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

HK (1)