Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic (AUTONOMIC)

This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake).

It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.

Study Overview

• Status: Completed
• Conditions: Occupational Stress
• Intervention / Treatment: Behavioral: Assessment of work-related stress; Biological: Saliva sample collection; Other: Cardiac and electrodermal recordings; Behavioral: Assessment of behavioral response to emotional stimulation

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Mulhouse, France
    • Elément Militaire de Réanimation (EMR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of people who have been deployed to serve at the mobile intensive care unit in Mulhouse (France) during the Covid-19 crisis.

Description

Inclusion Criteria:

• Volunteer staff member of the Mulhouse mobile intensive care unit (in French: Elément mobile de réanimation, EMR), including military reservists.

Exclusion Criteria:

• Pregnant or breastfeeding woman,
• Person deprived of liberty by a judicial or administrative decision,
• Person subject to a legal protection measure or unable of giving consent
• Intercurrent pathology with inability to work
• History of psychiatric disorder or cardiac pathology

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professional burnout	Professional burnout is measured at D21 by the Burnout Measure Short Version (BMS) questionnaire It is a 10-item questionnaire used to assess burnout regardless of the occupational category. Each item is rated from 0 to 6 ("never" to "always"). An average score (sum/10) below 2.4 indicates a very low degree of burnout exposure; a score between 2.5 and 3.4 indicates a low degree of burnout exposure; a score between 3.5 and 4.4 indicates the presence of burnout; a score between 4.5 and 5.4 indicates a high degree of burnout exposure; a score above 5.5 indicates a very high degree of burnout exposure.	21 days after enrollment (Day 21)
Mindfulness level	Mindfulness level is assessed at D0 thanks to the Freiburg Mindfulness Inventory. It is a 14 item scale. Each item is rated from 1 to 4 ("almost never" to "almost always"). The total score is between 14 and 56. The mean value in a population of young adults under 36 years of age is 38.5 (+/- 5.1 standard deviation).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress level following the emotional stimulation	Perceived stress level is assessed with the Perceived Stress Scale (PSS). It is a 14 item scale. Each item is rated from 0 to 5 ("never" to "very often"). The total score ranges from 0 to 56 with higher scores indicating greater perceived stress.	Day 1
Parasympathetic flexibility evolution during emotional recall	Parasympathetic flexibility is assessed through dynamic electro-physiological analysis of cardiac and electrodermal conductance recordings. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall.	Day 1
Sympathetic tone at rest	The activity of the sympathetic tone is assessed by the measurement of the resting state salivary Chromogranin A. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall. The activity of the sympathetic tone is assessed by the measurement of the resting salivary Chromogranin A.	Day 1
Corticotropic activation at rest	Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio	Day 1
Mood disorders (anxiety / depression)	The Hospital Anxiety and Depression Scale (HAD-s32) is used to assess mood disorders in the general non-psychiatric population. It is used to discriminate between anxiety and depression. Scores greater than 11 are indicative of charcaterized anxiety/depression.	Day 1
Post-traumatic stress disorder	Post-traumatic disorder is assessed with the PCL-5. It is a 20-item self-administered questionnaire representing DSM-5 PTSD diagnosis symptoms rated by the subject on a scale from 0 ("not at all") to 4 ("extremely") during the past month. Scores range from 0 to 80. A score greater than of 33 evokes the presence of post-traumatic stress disorder.	Day 1
Sleep quality	Sleep quality is assesses thanks to the Leeds Sleep Evaluation questionnaire (LEEDS). It consists of ten visual analogue scales assessing four aspects of sleep: (i) quality of falling asleep and degree of drowsiness, (ii) quality of sleep, (iii) quality of wakefulness, and (iv) quality of post-wakefulness and performance.	Day 1

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées
• Collaborators: Institut de Recherche Biomedicale des Armees

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2020
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stress, Psychological; Occupational Diseases; Burnout, Psychological; COVID-19; Burnout, Professional; Occupational Stress
• Other Study ID Numbers: 2020-COVID19-11; 2020-A01058-31 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No