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

Primary Purpose

Burnout, Professional, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcendental Meditation
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout, Professional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke University health system

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Transcendental Meditation Intervention Arm

Treatment as usual(TAU) Control Arm

Arm Description

TM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to a randomized group of eligible HCPs ( N=40)providing care during COVID-19 pandemic.

Control group consists of eligible HCPs who are randomized to control group(N=40) and would not receive any intervention. At the end of 3 month study period, control group participants would be eligible for TM training.

Outcomes

Primary Outcome Measures

change in self reported Stress symptoms
Changes in brief symptom inventory as evaluated by BSI 18

Secondary Outcome Measures

Change in self reported resilience
These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).
Change in symptoms of depression
Change in symptoms of depression will be measured by PHQ 9 scale
Change in insomnia symptoms
Change in insomnia symptoms as measured by Insomnia severity Index(ISI)
Change in anxiety symptoms
Change in anxiety symptoms as measured by GAD-7
Change in psychological distress
change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.
Change in self reported burnout symptoms
Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)

Full Information

First Posted
November 11, 2020
Last Updated
August 19, 2021
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04632368
Brief Title
Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
Official Title
Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Stress, Psychological

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcendental Meditation Intervention Arm
Arm Type
Active Comparator
Arm Description
TM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to a randomized group of eligible HCPs ( N=40)providing care during COVID-19 pandemic.
Arm Title
Treatment as usual(TAU) Control Arm
Arm Type
No Intervention
Arm Description
Control group consists of eligible HCPs who are randomized to control group(N=40) and would not receive any intervention. At the end of 3 month study period, control group participants would be eligible for TM training.
Intervention Type
Behavioral
Intervention Name(s)
Transcendental Meditation
Intervention Description
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 Outcome Measure Information:
Title
change in self reported Stress symptoms
Description
Changes in brief symptom inventory as evaluated by BSI 18
Time Frame
Baseline, 1 month, 3 months
Secondary Outcome Measure Information:
Title
Change in self reported resilience
Description
These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).
Time Frame
Baseline, 1 month, 3 months
Title
Change in symptoms of depression
Description
Change in symptoms of depression will be measured by PHQ 9 scale
Time Frame
Baseline, 1 month, 3 months
Title
Change in insomnia symptoms
Description
Change in insomnia symptoms as measured by Insomnia severity Index(ISI)
Time Frame
Baseline, 1 month, 3 months
Title
Change in anxiety symptoms
Description
Change in anxiety symptoms as measured by GAD-7
Time Frame
Baseline, 1 month, 3 months
Title
Change in psychological distress
Description
change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.
Time Frame
Baseline, 1 month, 3 months
Title
Change in self reported burnout symptoms
Description
Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)
Time Frame
Time Frame: Baseline, 1 month, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University health system
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36121655
Citation
Joshi SP, Wong AI, Brucker A, Ardito TA, Chow SC, Vaishnavi S, Lee PJ. Efficacy of Transcendental Meditation to Reduce Stress Among Health Care Workers: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231917. doi: 10.1001/jamanetworkopen.2022.31917.
Results Reference
derived

Learn more about this trial

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

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