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 @ 12:45 PM
Ignite Modification Date:
2025-12-24 @ 12:45 PM
NCT ID:
NCT05630261
Eligibility Criteria:
Inclusion Criteria:
1. Hong Kong residents aged between 18 and 65;
2. Able to read and type in Chinese;
3. Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 indicating at least moderate level of depressive symptoms;
4. Have an Insomnia Severity Index (ISI) score ≥ 10 indicating clinical level of insomnia symptoms;
5. Have an Internet-enabled mobile device (iOS or Android operating system); and
6. Willing to provide informed consent and comply with trial protocol
Exclusion Criteria:
1. Received psychotherapy for depression and/or insomnia in the past 6 months;
2. A Patient Health Questionnaire-9 (PHQ-9) item 9 score \> 2, indicating a serious level of suicidal risk (referral information to professional mental health services will be provided);
3. Any medical or neurocognitive disorder(s) that makes participation unsuitable or interferes with adherence to the proposed interventions;
4. Other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS) / periodic leg movement disorder (PLMD) based on the SLEEP-50;
5. A change in psychotropic drugs or over-the-counter medications that target depression and/or insomnia within 2 weeks before the baseline assessment;
6. Shift work, pregnancy, or other commitments that interfere with regular sleep-wake patterns; and
7. Hospitalisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05630261
Study Brief:
Protocol Section:
NCT05630261