EMI Therapy for Depression in Hong Kong (NCT06430476) | Clinical Trial Compass
UnknownNot Applicable
EMI Therapy for Depression in Hong Kong
Hong Kong80 participantsStarted 2024-06-30
Plain-language summary
To determine if a two-week ecological momentary intervention (two EMA + one EMI daily) as augmentation to treatment as usual would reduce depressive symptoms, rumination levels, and functioning in subjects with mild to moderate depression, as compared to active controls receiving three EMA prompts daily.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 16-65 years
* Cantonese-speaking ethnic Chinese
* Diagnosis of major depressive episode (MDE) established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorder 5th Edition (DSM-V)
* 17-item Hamilton Depression Rating Scale (HDRS) ≥ 14 at screening and at baseline (i.e. moderate to severe depression)
* Having a smartphone with Internet access and iOS or Android operating system.
Exclusion Criteria:
* Patients who could not read Chinese, are unable to provide informed consents
* Comorbid with other Axis I diagnoses (especially schizoaffective disorder)
* With an unstable medical condition or current substance abuse
* Have a score of ≥4 on any one of the three items on Positive and Negative Syndrome Scale (P1 Delusion, P2 Conceptual disorganization, P3 Hallucination)
* Marked risk of self-harm or suicide that could not be safely managed in an outpatient clinic setting
* Currently receiving any other weekly psychosocial therapy
* Unable to use a smartphone-based application due to cognitive impairment or learning disability or inadequate vision.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ecological Momentary Assessment (EMA) outcomes
Timeframe: During intervention
2
Montgomery-Åsberg Depression Rating Scale (MADRS)
Timeframe: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)