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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Positive and negative affect [Срок оценки: Five times per day during the 2-week trial period.]

Вторичные конечные точки (5)

• Depression [Срок оценки: Baseline, 2-week post-intervention, 1-month follow-up]
• Anxiety [Срок оценки: Baseline, 2-week post-intervention, 1-month follow-up]
• Stress [Срок оценки: Baseline, 2-week post-intervention, 1-month follow-up]
• Sleep quality [Срок оценки: Baseline, 2-week post-intervention, 1-month follow-up]
• Mindfulness [Срок оценки: Baseline, 2-week post-intervention, 1-month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Kowloon

Идентификаторы

NCT: NCT07717112 · P0056181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗