Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT05454761
Eligibility Criteria:
Inclusion Criteria:
1. at least 18 years of age
2. Cantonese language fluency and readability
3. a PHQ-9 score of at least 10, indicating a moderate level of depression
4. current DSM-IV diagnostic criteria of major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
5. possession of an internet-enabled mobile device (iOS or Android operating system)
6. willingness to provide informed consent and comply with the trial protocol.
Exclusion Criteria:
1. the presence of other current psychiatric disorders as assessed by the MINI
2. any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
3. current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score \> 2 (referral information to professional mental health services will be provided)
4. current involvement in lifestyle changes supervised by professionals
5. intake of medication or current participation in any psychotherapy for depression
6. pregnancy
7. hospitalization
8. current participation in any other trial(s).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05454761
Study Brief:
Protocol Section:
NCT05454761