Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents

NCT07717112 | Not Yet Recruiting DMC

• 1 other identifier: P0056181
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A two-arm randomized controlled trial (RCT) will be conducted to test a mobile-based intervention, E-breathing, for early detection and intervention to address psychological distress in at-risk adolescents in Hong Kong. E-breathing harnesses the science of real-time, in-situ assessment approach - Ecological Momentary Assessment (EMA) - to capture the psychological symptoms and needs of adolescents. Based on the real-time data collected via smartphone, the mobile application prompts the practice of slow-paced breathing as an Ecological Momentary Intervention (EMI) to reduce psychological distress. This RCT will recruit a total of 100 participants who will be randomly allocated to either (1) an intervention group (EMI group), where they will receive a feedback prompt when they score high on negative affect (i.e., E-breathing) or (2) the control group (EMA group), where they will only complete EMAs without feedback. This project aims to investigate the feasibility and effectiveness of E-breathing in improving psychological symptoms in Hong Kong adolescents. This project also examine the underlying physio-mechanisms of the effects of E-breathing on psychological outcomes in this target population.

Conditions

Psychological Distress; Depressed Mood; Anxiety; Stress

Outcome Measures

Primary Outcomes (1)

• Positive and negative affect

  Positive affect (PA) subscale will be calculated by averaging the PA items (items: at this moment I feel satisfied, relaxed, cheerful, energetic, enthusiastic, and calm), and a negative affect (NA) subscale will be calculated by averaging the NA items (items: at this moment I feel upset, irritated, listless/apathic, down, nervous, bored, anxious). All ratings will use a 7-point Likert scale, where 1 means not at all and 7 means very much.

  Five times per day during the 2-week trial period.

Secondary Outcomes (5)

• Depression

  Baseline, 2-week post-intervention, 1-month follow-up

• Anxiety

  Baseline, 2-week post-intervention, 1-month follow-up

• Stress

  Baseline, 2-week post-intervention, 1-month follow-up

• Sleep quality

  Baseline, 2-week post-intervention, 1-month follow-up

• Mindfulness

  Baseline, 2-week post-intervention, 1-month follow-up

Other Outcomes (1)

• Heart Rate Variability

  HRV data will be collected during the two-week intervention period while the mobile application (E-Breathing) is in use.

Study Arms (2)

EMI group

EXPERIMENTAL

In addition to completing ecological momentary assessments (EMAs) survey, the EMI group will receive prompts to practice slow-paced breathing during the 2-week trial period. After completing each EMA core survey, the mHealth platform will automatically analyze the EMA data and notify participants who reported high negative affect (mean score ≥ 3) to voluntarily slow down their breathing rate. Specifically, participants will be required to breathe at a rate of 6 respiratory cycles per minute, using nasal breathing, with a 1: 1 ratio of inspiratory: expiratory duration. During each practice, the participants will be instructed to assume a relaxed position, close their eyes, and passively ignore distracting thoughts while engaging in repetitive breathing exercises for 3 min each.

Behavioral: Slow-paced breathing via ecological momentary intervention

EMA control group

ACTIVE COMPARATOR

The control group (EMA group) will follow the EMA data collection procedure as same as EMI intervention group but will not receive any feedback via the app. The EMA group is included in this trial to investigate reactivity and whether completing mobile assessments alone (without slow breathing-prompt feedback) will affect the mental health status of participants.

Behavioral: Ecological momentary assessments

Interventions

Ecological momentary assessments BEHAVIORAL

The EMA core survey measures seven negative affect (e.g., irritated, sad, ruminating) and six positive affect (e.g., cheerful, relaxed, content). Response options for these items are on a 7-point scale. The app will program to send out these core items 5 times per day.

EMA control group

Slow-paced breathing via ecological momentary intervention BEHAVIORAL

The EMA core survey measures seven negative affect (e.g., irritated, sad, ruminating) and six positive affect (e.g., cheerful, relaxed, content). Response options for these items are on a 7-point scale. The application will program to send out these core items 5 times per day. In addition to completing EMAs, the EMI group will receive prompts to practice slow-paced breathing during the 2-week trial period. After completing each EMA core survey, the mHealth platform will automatically analyze the EMA data and notify participants who reported high negative affect (mean score ≥ 3) to voluntarily slow down their breathing rate. Specifically, participants will be required to breathe at a rate of 6 respiratory cycles per minute, using nasal breathing, with a 1: 1 ratio of inspiratory: expiratory duration. During each practice, the participants will be instructed to assume a relaxed position, close their eyes, and passively ignore distracting thoughts while engaging in repetitive breathing

EMI group

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 11 to17 years;
• With at least one mild mental health state as reported by Depression, Anxiety, and Stress Scale-21;
• Able to read and understand Chinese;
• Have access to a mobile phone and data plan.

You may not qualify if:

• With a diagnosis of hearing, visual, or physical impairments that may hinder study participation;
• With a diagnosed history of major mental illnesses or other diagnosed medical conditions that may affect study participation.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Consciousness Disorders; Anxiety Disorders

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Dr. He, Ph.D.

CONTACT

+852 3400 3273; stacy-jl.he@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)