Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19 (NCT04922632) | Clinical Trial Compass
TerminatedNot Applicable
Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
Stopped: Funding was exhausted
United States212 participantsStarted 2022-02-21
Plain-language summary
The United States is battling dual pandemics: healthcare provider (HCP) exhaustion and COVID-19. The COVID-19 pandemic death toll has surpassed 595,000 and continues to climb as the worldwide outbreak continues. Moreover, we have yet to understand the health impacts of "long-COVID". As evidenced by the national burnout epidemic in HCPs, persistent workplace stress not only impacts personal provider wellbeing, but also influences effective practice and patient outcomes.
To address this need, we propose a 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT) comparing 2 non-pharmacological interventions: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM) to Treatment as Usual (TAU).
Participation in this study lasts up to 24 months for enrolled participants and is considered minimal risks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Full-time HCPs
. A score of \>= 5 on the Subjective Units of Distress Scale (SUDS) at baseline visit.
. Willingness to address burnout symptoms by non-pharmacological means.
. 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).
. Willingness to download the PatternHealth app on personal device.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in resilience as measured by the Connor-Davidson Resilience Scale-25
. Addition or change in dosage of psychotropic medications, beta-blockers, or anti-epileptic medications within the last 2 months
. 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.
. Current suicidal or homicidal ideation at the time of screening, as defined by the C-SSRS.
. Prior instruction in the Transcendental Meditation (TM) technique by a certified instructor.