Skip to main content
OpenTrials
Completed

NCT Number: NCT04632368

Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University health system

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Antipsychotic medications or beta-blockers
  • Current suicidal or homicidal ideation (suicidal ideation as screened by C-SSRI survey pre-enrollment)
  • Previous instruction in TM

Treatment and study plan

Transcendental Meditation

Behavioral

TM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to HCPs dealing with COVID-19 pandemic

Primary outcomes

  1. change in self reported Stress symptoms

    Time frame: Baseline, 1 month, 3 months

    Changes in brief symptom inventory as evaluated by BSI 18

Secondary outcomes

  1. Change in self reported resilience

    Time frame: Baseline, 1 month, 3 months

    These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).

  2. Change in symptoms of depression

    Time frame: Baseline, 1 month, 3 months

    Change in symptoms of depression will be measured by PHQ 9 scale

  3. Change in insomnia symptoms

    Time frame: Baseline, 1 month, 3 months

    Change in insomnia symptoms as measured by Insomnia severity Index(ISI)

  4. Change in anxiety symptoms

    Time frame: Baseline, 1 month, 3 months

    Change in anxiety symptoms as measured by GAD-7

  5. Change in psychological distress

    Time frame: Baseline, 1 month, 3 months

    change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.

  6. Change in self reported burnout symptoms

    Time frame: Time Frame: Baseline, 1 month, 3 months

    Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2020
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.