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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT05086120
Eligibility Criteria:
Inclusion Criteria:
* 13-18 years old at baseline
* Mood and Feelings Questionnaire - Childhood, long version (MFQ) score of ≥22
* Diagnosis of Major Depressive Disorder by impression from the referring psychiatrist and confirmed using the KSADS
* Internet access at home
* Access to a smartphone for personal and private use, with an associated standard data plan (ie. greater than or equal to 500 MB/month)
* Able to speak and read English fluently
Exclusion Criteria:
* Individuals that arecurrently receiving structured psychotherapy
* Clinically significant suicidal ideation that is defined as 'imminent intent' or attempted suicide in the past 6 months
* Co-morbid diagnosis of borderline personality disorder (as assessed by the Childhood Interview for Borderline Personality Disorder) (Zanarini, 2003), schizophrenia, bipolar disorder, moderate-to-severe eating disorder, obsessive compulsive disorder and/or severe alcohol/substance use disorder in the past 3 months
* Youth with known or clinically suspected intellectual disability or autism spectrum disorder
* Youth who are not able to provide informed consent for any other reason
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT05086120
Study Brief:
Protocol Section:
NCT05086120