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NCT07717112

Overview

NCT ID: NCT07717112
Lead Sponsor: The Hong Kong Polytechnic UniversityOTHER
Official Title: Effect of Slow-Paced Breathing Via Ecological Momentary Intervention on Reducing Psychological Distress in Adolescents: A Randomized Controlled Trial
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Jan 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 100Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Dr. He, Ph.D.Contact
stacy-jl.he@connect.polyu.hk+852 3400 3273

Similar Studies

Participant Group/Arms

EMI groupExperimental

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 groupActive 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