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

NCT04632368 | Completed

• 1 other identifier: Pro00106191
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Burnout, Professional; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• change in self reported Stress symptoms

  Changes in brief symptom inventory as evaluated by BSI 18

  Baseline, 1 month, 3 months

Secondary Outcomes (6)

• Change in self reported resilience

  Baseline, 1 month, 3 months

• Change in symptoms of depression

  Baseline, 1 month, 3 months

• Change in insomnia symptoms

  Baseline, 1 month, 3 months

• Change in anxiety symptoms

  Baseline, 1 month, 3 months

• Change in psychological distress

  Baseline, 1 month, 3 months

Study Arms (2)

Transcendental Meditation Intervention Arm

ACTIVE COMPARATOR

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.

Behavioral: Transcendental Meditation

Treatment as usual(TAU) Control Arm

NO INTERVENTION

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.

Interventions

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

Transcendental Meditation Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University health system

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 36121655 DERIVED

MeSH Terms

Conditions

Burnout, Professional; Stress, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 17, 2020
• Study Start: November 20, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 16, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)