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临床试验/NCT07717112
NCT07717112尚未招募不适用

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

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Positive and negative affect

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Positive and negative affect

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

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TSANG Hector Wing-Hong

Professor

The Hong Kong Polytechnic University

研究点 (1)

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