Anxiety, Depressed Mood, Psychological Distress, Stress
Conditions
Brief 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. 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.
Interventions
BEHAVIORALSlow-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
BEHAVIORALEcological 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and negative affect | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 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. |
| Anxiety | 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. |
| Stress | 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. |
| Sleep quality | 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. |
| Mindfulness | 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. |
Countries
Hong Kong
Contacts
CONTACTDr. He, Ph.D.
Outcome results
None listed