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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT05753605
Eligibility Criteria:
Inclusion Criteria:
* 18+ years of age
* Experiencing mental health symptoms associated with one or more mental health conditions including major depression, bipolar disorder, anxiety disorder or schizophrenia as defined by cut off scores on validated screening instruments OR a self-reported clinician confirmed diagnosis of a major mood disorder, anxiety disorder or psychotic spectrum disorder at baseline.
* Major depression (Patient Health Questionnaire (PHQ-9)): total score 10+
* Bipolar disorder (Mood Disorder Questionnaire (MDQ)): yes to 6+ items on question 1
* Anxiety disorder (Generalized Anxiety Disorder Scale (GADS-7)): Total score 10+
* Psychotic spectrum (Prodromal Questionnaire - Brief version (PQ-B)): a cut-off of 6+ endorsed positive items and 6+ for the distress subscale total score
* Able to speak, write and read English, given the app will be available only in English
* Able to provide informed consent
* Participants must have a personally owned iPhone 5s or newer (iOS 12 or higher) and use their phone for this study. This includes a willingness to download and use the study applications and sync their phone with the necessary study devices.
* Willingness to continuously wear a personally owned wearable device and permit researcher access to pre-identified streams of data (BYOD arm only) Willingness to continuously wear the Oura smartring and permit research access to its data (Oura arm only)
Exclusion Criteria:
* Not willing to permit access to wearable device data or use the study smartphone applications
* Currently or attempting to get pregnant
Cortisol Sub-arm Inclusion Criteria:
For participants interested in the hair cortisol sub-arm, they will have to meet the following inclusion criteria:
* Willing to extract 50-60 hairs from the back of the head
* Hair at least 6 centimeters long
* Not currently taking glucocorticoid containing medication (e.g., beclomethasone, betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05753605
Study Brief:
Protocol Section:
NCT05753605