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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT04922632
Eligibility Criteria:
Inclusion Criteria:
1. Full-time HCPs
2. A score of \>= 5 on the Subjective Units of Distress Scale (SUDS) at baseline visit.
3. Willingness to address burnout symptoms by non-pharmacological means.
4. Willingness to wear the provided wearable device (e.g., Apple, Empatica, and/or eSense) at the designated study visits and/or determined coaching sessions, as well as wear an Apple device, if eligible to receive an Apple watch, from baseline for the duration of the study (up to 24 months).
5. Willingness to download the PatternHealth app on personal device.
Exclusion Criteria:
1. Addition or change in dosage of psychotropic medications, beta-blockers, or anti-epileptic medications within the last 2 months
2. HCPs may re-present for screening again after 2 months has passed since their last change in the medication categories listed that previously excluded them for re-evaluation for study eligibility.
3. Current suicidal or homicidal ideation at the time of screening, as defined by the C-SSRS.
4. Prior instruction in the Transcendental Meditation (TM) technique by a certified instructor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04922632
Study Brief:
Protocol Section:
NCT04922632