Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
Completed · Not applicable
Conditions studied: Burnout, Professional, Stress, Psychological
In brief
This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation
Key facts
- Study ID
- NCT04632368
- Run by
- Duke University
- People needed
- 80
- Starts
- 2020-11-20
- Expected to finish
- 2021-08-16
- Last updated by the study team
- 2021-08-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- HCPs including physicians, trainee physicians, nurses, nurse practitioners, Physician Assistants, and respiratory therapists providing patient care during the COVID-19 pandemic.
- A single-item stress scale will be used as a screen for eligibility; a minimum score of 6 on a 10-point response scale will be needed to meet inclusion criteria
- Subjects who have at least a 5% increase from baseline in heart rate after exposure to a personalized stressful script OR at least a 33% increase in skin conductance after exposure to the script
- Willingness to address burnout symptoms by non-pharmacological means
- All subjects must provide Informed Consent prior to enrollment in the study.
- Willingness to wear the provided Apple Watch for the data collection process
You may not qualify if…
- Antipsychotic medications or beta-blockers
- Current suicidal or homicidal ideation (suicidal ideation as screened by C-SSRI survey pre-enrollment)
- Previous instruction in TM
Where it is running
- Duke University health system — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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