Psychological DistressNCT07717112
Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents
A study testing Slow-paced breathing via ecological momentary intervention and Ecological momentary assessments in people with Psychological Distress and Depressed Mood, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Psychological Distress, Depressed Mood, Anxiety
- What is being tested?
- Slow-paced breathing via ecological momentary intervention and Ecological momentary assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Hong Kong Polytechnic University
Kowloon
Dr. He, Ph.D., +852 3400 3273, stacy-jl.he@connect.polyu.hk
About this study
Official title: 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.
- Conditions
- Psychological Distress, Depressed Mood, Anxiety, Stress
- Being tested
- Slow-paced breathing via ecological momentary intervention, Ecological momentary assessments
- Medical subject headings
- Consciousness Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-paced breathing via ecological momentary interventionBehavioural
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
Ecological momentary assessmentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EMI group | Experimental | 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. Receives: Behavioral: Slow-paced breathing via ecological momentary intervention |
| EMA control group | Active comparator | 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. Receives: Behavioral: Ecological momentary assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative affect
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.
Measured: Five times per day during the 2-week trial period.
Secondary outcomes (5)
Depression
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.
Measured: Baseline, 2-week post-intervention, 1-month follow-up
Anxiety
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.
Measured: Baseline, 2-week post-intervention, 1-month follow-up
Stress
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.
Measured: Baseline, 2-week post-intervention, 1-month follow-up
Sleep quality
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.
Measured: Baseline, 2-week post-intervention, 1-month follow-up
Mindfulness
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.
Measured: Baseline, 2-week post-intervention, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717112
- Sponsor's protocol ID
- P0056181
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Slow-Paced Breathing Via Ecological Momentary Intervention on Reducing Psychological Distress in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07717112
- Acronym / sponsor ID
- P0056181
- Conditions
- Psychological Distress, Depressed Mood, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMI group | Experimental | Behavioral: Slow-paced breathing via ecological momentary interventionIn 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. |
| EMA control group | Active comparator | Behavioral: Ecological momentary assessmentsThe 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-paced breathing via ecological momentary interventionThe 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 | Behavioural | EMI group |
| Ecological momentary assessmentsThe 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. | Behavioural | EMA control group |
Primary outcome
Positive and negative affect
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes
Related trials for Psychological Distress
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Not yet recruiting
Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
Psychological Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-paced breathing via ecological momentary intervention and Ecological momentary assessments in people with Psychological Distress and Depressed Mood, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. He, Ph.D. (+852 3400 3273, stacy-jl.he@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and negative affect (time frame: Five times per day during the 2-week trial period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.