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

16. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged between 11 to17 years;
  2. With at least one mild mental health state as reported by Depression, Anxiety, and Stress Scale-21;
  3. Able to read and understand Chinese;
  4. Have access to a mobile phone and data plan.

Exclusion Criteria:

  1. With a diagnosis of hearing, visual, or physical impairments that may hinder study participation;
  2. With a diagnosed history of major mental illnesses or other diagnosed medical conditions that may affect study participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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 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
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive and negative affect
Tidsramme: 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.
Five times per day during the 2-week trial period.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression
Tidsramme: Baseline, 2-week post-intervention, 1-month follow-up
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.
Baseline, 2-week post-intervention, 1-month follow-up
Anxiety
Tidsramme: Baseline, 2-week post-intervention, 1-month follow-up
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.
Baseline, 2-week post-intervention, 1-month follow-up
Stress
Tidsramme: Baseline, 2-week post-intervention, 1-month follow-up
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.
Baseline, 2-week post-intervention, 1-month follow-up
Sleep quality
Tidsramme: Baseline, 2-week post-intervention, 1-month follow-up
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.
Baseline, 2-week post-intervention, 1-month follow-up
Mindfulness
Tidsramme: Baseline, 2-week post-intervention, 1-month follow-up
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.
Baseline, 2-week post-intervention, 1-month follow-up

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart Rate Variability
Tidsramme: HRV data will be collected during the two-week intervention period while the mobile application (E-Breathing) is in use.
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.
HRV data will be collected during the two-week intervention period while the mobile application (E-Breathing) is in use.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Hong Kong Polytechnic University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P0056181

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