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

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ClinicalTrials.gov Identifier: NCT04365335
Recruitment Status : Completed
First Posted : April 28, 2020
Last Update Posted : August 17, 2020
Sponsor:
Collaborator:
Institut de Recherche Biomedicale des Armees
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Brief Summary:

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.


Condition or disease Intervention/treatment
Occupational Stress Behavioral: Assessment of work-related stress Biological: Saliva sample collection Other: Cardiac and electrodermal recordings Behavioral: Assessment of behavioral response to emotional stimulation

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic
Actual Study Start Date : April 25, 2020
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Assessment of work-related stress
    Assessment of burnout, mindfulness, interoceptive awareness, anxiety, post-traumatic stress disorder, coping flexibility and sleep through questionnaires.
  • Biological: Saliva sample collection
    Saliva sample is collected before and after emotional stimulation in order to measure resting-state allostatic load biomarkers: DHEA, cortisol and chromogranine A levels
  • Other: Cardiac and electrodermal recordings
    Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.
  • Behavioral: Assessment of behavioral response to emotional stimulation

    Emotional stimulation involves asking the participants to remember a recent event related to the COVID-19 crisis that has been emotionally difficult for them.

    Perceived stress, situational awareness and emotions is assessed after emotional stimulation through questionnaires.



Primary Outcome Measures :
  1. Professional burnout [ Time Frame: 21 days after enrollment (Day 21) ]

    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.


  2. Mindfulness level [ Time Frame: Day 1 ]

    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).



Secondary Outcome Measures :
  1. Perceived stress level following the emotional stimulation [ Time Frame: Day 1 ]
    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.

  2. Parasympathetic flexibility evolution during emotional recall [ Time Frame: Day 1 ]

    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.


  3. Sympathetic tone at rest [ Time Frame: Day 1 ]

    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.


  4. Corticotropic activation at rest [ Time Frame: Day 1 ]
    Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio

  5. Mood disorders (anxiety / depression) [ Time Frame: Day 1 ]
    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.

  6. Post-traumatic stress disorder [ Time Frame: Day 1 ]
    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.

  7. Sleep quality [ Time Frame: Day 1 ]
    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.


Biospecimen Retention:   Samples Without DNA
Saliva sample


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365335


Locations
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France
Elément Militaire de Réanimation (EMR)
Mulhouse, France
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Institut de Recherche Biomedicale des Armees
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04365335    
Other Study ID Numbers: 2020-COVID19-11
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Occupational Stress
Burnout, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Diseases