Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Burnout, Professional
  • Stress Psychological
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Eligible participants, on enrollment in the study, would be randomly assigned to meditation intervention group vs control group. Control group will be offered intervention at the end of the studyMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

OVERALL HYPOTHESIS: HCPs who learn and practice TM will demonstrate significantly improved symptoms of burnout within 3 months, as measured by self-report (survey), physiologic, and neuro-functional imaging studies. SPECIFIC AIM 1: To conduct a single-blind, randomized, controlled trial (RCT) of TM ...

OVERALL HYPOTHESIS: HCPs who learn and practice TM will demonstrate significantly improved symptoms of burnout within 3 months, as measured by self-report (survey), physiologic, and neuro-functional imaging studies. SPECIFIC AIM 1: To conduct a single-blind, randomized, controlled trial (RCT) of TM (N=40) vs. Control (CTL, N=40) in frontline HCPs. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS). 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). SPECIFIC AIM 2: Evaluate changes (pre/post-treatment) in heart rate variability (HRV), a physiological measure of stress, and overall cardiovascular resilience) in response to TM practice versus CTL. Participants will be asked to wear an Apple Watch throughout trial participation to assess changes in resting HRV during meditative practice. Galvanic Skin Response (GSR) refers to the changes in sweat gland activity that result from changes in an emotional state. A portable GSR device (e-Sense Skin Response) will be used to evaluate GSR score (baseline and 3 months). fMRI (N=20 for each group) will be performed by the Duke Brain Imaging and Analysis Center (BIAC). fMRI Protocol: The first 20 eligible (exclusion criteria: pregnancy, claustrophobia, reluctance to participate) patients from each group will be randomly assigned to get fMRI at baseline and at the end of the study.

Tracking Information

NCT #
NCT04632368
Collaborators
Not Provided
Investigators
Not Provided