Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents
16. července 2026 aktualizováno: TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
Effect of Slow-Paced Breathing Via Ecological Momentary Intervention on Reducing Psychological Distress in Adolescents: A Randomized Controlled Trial
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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Dr. He, Ph.D.
- Telefonní číslo: +852 3400 3273
- E-mail: stacy-jl.he@connect.polyu.hk
Studijní místa
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Kowloon, Hongkong
- The Hong Kong Polytechnic University
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Kontakt:
- Dr. He, Ph.D.
- Telefonní číslo: +852 3400 3273
- E-mail: stacy-jl.he@connect.polyu.hk
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: EMI group
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.
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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
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Aktivní komparátor: EMA control group
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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Positive and negative affect
Časové okno: Five times per day during the 2-week trial period.
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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.
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Five times per day during the 2-week trial period.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Depression
Časové okno: Baseline, 2-week post-intervention, 1-month follow-up
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This will be assessed by the Chinese version of the Beck Depression Inventory-II (BDI-II).
The BDI-II is a 21-item self-report inventory designed to assess the presence and severity of depressive symptoms.
Each item is rated on a 4-point Likert scale ranging from 0 to 3, based on the severity in the last two weeks.
The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.
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Baseline, 2-week post-intervention, 1-month follow-up
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Anxiety
Časové okno: Baseline, 2-week post-intervention, 1-month follow-up
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This will be assessed by the Chinese version of the Beck Anxiety Inventory (BAI).
The BAI is a 21-item self-report questionnaire that asks about common symptoms of anxiety, such as feeling nervous, scared, and fear of dying, and was designed to distinguish anxiety symptoms from depressive symptoms.
Each item is rated on a 4-point Likert scale for symptom severity in the past week, ranging from 0 (not at all) to 3 (severely).
The range of total scores is from 0 to 63, with higher scores suggesting greater degrees of anxiety.
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Baseline, 2-week post-intervention, 1-month follow-up
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Stress
Časové okno: Baseline, 2-week post-intervention, 1-month follow-up
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This will be assessed by the Chinese version of the Perceived Stress Scale 10-item (PSS-10).
The PSS-10 is a self-report instrument that assesses global stress or how life situations are appraised as unpredictable, uncontrollable, and overloading.
Respondents report the prevalence of an item within the last two weeks on a 5-point scale, ranging from 0 (never) to 4 (very often).
Scoring is completed by reverse scoring four positively worded items (4, 5, 7, and 8) and summing all item scores.
Scale scores range from 0-40, with higher scores indicating higher stress levels.
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Baseline, 2-week post-intervention, 1-month follow-up
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Sleep quality
Časové okno: Baseline, 2-week post-intervention, 1-month follow-up
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This will be measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI).
The index consists of a 19-item questionnaire evaluating sleep quality and disturbances over the past two weeks.
The first four items are open questions, whereas items five to 19 are rated on a four-point Likert scale.
Individual item scores yield seven components.
A total score is obtained by adding together the seven component scores.
A higher score indicates poorer sleep quality.
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Baseline, 2-week post-intervention, 1-month follow-up
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Mindfulness
Časové okno: Baseline, 2-week post-intervention, 1-month follow-up
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This will be evaluated by the Chinese version of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R).
This 12-item scale measures the mindfulness experienced by individuals in four dimensions: attention, present focus, awareness, and acceptance (e.g., "It is easy for me to concentrate on what I am doing," "I am easily distracted").
All the items will be rated using a 4-point Likert scale (1 = rarely/not at all to 4 = almost always).
After reversing the scores of items 2, 6, and 7, higher total scores reflect greater mindfulness qualities.
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Baseline, 2-week post-intervention, 1-month follow-up
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Heart Rate Variability
Časové okno: HRV data will be collected during the two-week intervention period while the mobile application (E-Breathing) is in use.
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Heart rate variability (HRV) will be measured by the Polar H10 Sensor worn by some participants throughout the intervention period.
Stress-response dysfunction is associated with impaired autonomic nervous system activity, as indexed by decreased HRV in stress, anxiety, and depression.
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HRV data will be collected during the two-week intervention period while the mobile application (E-Breathing) is in use.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. října 2026
Primární dokončení (Odhadovaný)
31. ledna 2027
Dokončení studie (Odhadovaný)
31. května 2027
Termíny zápisu do studia
První předloženo
13. července 2026
První předloženo, které splnilo kritéria kontroly kvality
16. července 2026
První zveřejněno (Aktuální)
21. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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