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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT06566235
Eligibility Criteria:
Inclusion Criteria:
* 12-17 years of age,
* informed consent is provided by the youth and one of the parents,
* Mandarin Chinese language proficiency sufficient to complete study questionnaire,
* a total score of either the PHQ-9≥ 10 or the GAD-7 ≥ 10,
* a current diagnosis of depressive or anxiety disorder from a K-SADS-E interview, including depression (F32-33); persistent mood disorder (F34), phobic anxiety disorder (F40), other anxiety disorder (F41), and adjustment disorders (F43.2).
Individuals with comorbid diagnoses of several emotional disorders are also enrolled. Comorbidities will not be stratified because this will significantly increase the complexity of the design (i.e., some patients may have multiple comorbid diagnoses).
Exclusion Criteria:
* diagnoses of intellectual disability, schizophrenia, pervasive developmental disorder, anorexia nervosa and substance use disorder in the past 3 months,
* active suicidal ideation with a plan or a history of frequent or recent suicide risk in the past 3 months,
* ADHD without elevations in the areas of anxiety, depression, or stress problems on the CBCL,
* recent (past 4 weeks) change in psychiatric medication or unwillingness to maintain a stable dosage of medication during study participation,
* had received five or more sessions of CBT in the past or unwilling to stop concurrent psychotherapy,
* any mental or physical condition requiring hospital admission,
* severe medical condition.
As we also aim for a naturalistic setting, we do not exclude patients who undergo medication changes during the trial if the treating clinician judges this to be necessary or clinically important.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT06566235
Study Brief:
Protocol Section:
NCT06566235