Ecological Momentary Intervention (E-Breathing) to Reduce Psychological Distress in Adolescents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorThe Hong Kong Polytechnic University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Slow-paced breathing via ecological momentary intervention
BehavioralThe 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 assessments
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: EMI groupExperimental treatment 1 intervention
Group B: EMA control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Five times per day during the 2-week trial period.Secondary outcomes
1
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.
Time frame
Baseline, 2-week post-intervention, 1-month follow-up2
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.
Time frame
Baseline, 2-week post-intervention, 1-month follow-up3
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.
Time frame
Baseline, 2-week post-intervention, 1-month follow-up4
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.
Time frame
Baseline, 2-week post-intervention, 1-month follow-upOther outcomes
1
Heart Rate Variability
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.
Time frame
HRV data will be collected during the two-week intervention period while the mobile application (E-Breathing) is in use.Sponsors and contacts
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Source ClinicalTrials.gov
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