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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT03000894
Eligibility Criteria:
Inclusion Criteria:
* Hong Kong residents
* Aged ≥ 18 years
* Able to to communicate in Cantonese and write in Chinese
* First episode of depressive or bipolar disorders according to the DSM-5 diagnostic criteria
* Having received psychiatric treatment for less than 12 months
* Meeting the DSM-5 diagnostic criteria for insomnia disorder for at least 1 month, instead of at least 3 months, as in criterion D.
Exclusion Criteria:
* Significant cognitive impairments and psychotic symptoms, based on a Mini-mental State Examination score of 23 or below and the Positive and Negative Syndrome Scale items on delusions, conceptual disorganization, and hallucinatory behavior at moderate severity or above
* A diagnosis of schizophrenia, delusional disorder, neurocognitive disorders, or learning disability
* Having a highly unstable medical or psychiatric condition (including strong suicidal risk) that requires hospitalization
* Having an untreated sleep disorder, including narcolepsy, obstructive sleep apnea, and periodic leg movement disorder
* Past or current treatment with CBT-I
* Having a fear of speaking in a group setting or refusal to give informed consent
* Refuse to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03000894
Study Brief:
Protocol Section:
NCT03000894