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Not yet recruiting NCT07717112

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

No phase Interventional Psychological Distress Depressed Mood Anxiety Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Slow-paced breathing via ecological momentary intervention, Ecological momentary assessments.
Who it may be relevant to
Registry conditions: Psychological Distress, Depressed Mood, Anxiety, Stress. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Slow-Paced Breathing Via Ecological Momentary Intervention on Reducing Psychological Distress in Adolescents: A Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral Slow-paced breathing via ecological momentary intervention
    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
  • Behavioral Ecological momentary assessments
    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.

Primary outcome measures

  • Positive and negative affect [Time frame: Five times per day during the 2-week trial period.]
Secondary outcome measures (5)
  • Depression [Time frame: Baseline, 2-week post-intervention, 1-month follow-up]
  • Anxiety [Time frame: Baseline, 2-week post-intervention, 1-month follow-up]
  • Stress [Time frame: Baseline, 2-week post-intervention, 1-month follow-up]
  • Sleep quality [Time frame: Baseline, 2-week post-intervention, 1-month follow-up]
  • Mindfulness [Time frame: Baseline, 2-week post-intervention, 1-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Kowloon

Identifiers

NCT: NCT07717112 · P0056181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗