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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632368
• Other study ID #: Pro00106191
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: August 16, 2021

Study information

• Verified date: May 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 16, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Stress, Psychological

Intervention

Behavioral:
• Transcendental Meditation
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

Locations

Country	Name	City	State
United States	Duke University health system	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in self reported Stress symptoms	Changes in brief symptom inventory as evaluated by BSI 18	Baseline, 1 month, 3 months
Secondary	Change in self reported resilience	These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).	Baseline, 1 month, 3 months
Secondary	Change in symptoms of depression	Change in symptoms of depression will be measured by PHQ 9 scale	Baseline, 1 month, 3 months
Secondary	Change in insomnia symptoms	Change in insomnia symptoms as measured by Insomnia severity Index(ISI)	Baseline, 1 month, 3 months
Secondary	Change in anxiety symptoms	Change in anxiety symptoms as measured by GAD-7	Baseline, 1 month, 3 months
Secondary	Change in psychological distress	change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.	Baseline, 1 month, 3 months
Secondary	Change in self reported burnout symptoms	Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)	Time Frame: Baseline, 1 month, 3 months