Clinical trial NCT04517136: Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
Official title: Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
SARS-CoV Infection
Burnout, Caregiver
Burnout, Professional
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of:

* people who have been working working i) at the "Groupement Hospitalier de la Région de Mulhouse Sud Alsace" (GHRMSA) during the COVID-19 crisis
* people of the "Groupement Commando Montagne" (GCM) deployed in Mali in June 2020.

Brief summary: Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress).

The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes.

The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response.

The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context.

The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.


Eligibility criteria: Inclusion Criteria:

* Volunteer personnel i) working at the "Groupement Hospitalier de la Région de Mulhouse Sud Alsace" (GHRMSA) during the COVID-19 crisis OR ii) of the "Groupement Commando Montagne" (GCM) deployed in Mali in June 2020.

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

Primary outcomes:
measure: Professional burnout
timeFrame: 21 days after enrollment (Day 21)
measure: Mindfulness level
timeFrame: Day 1
Secondary outcomes:
measure: Perceived stress level following the emotional stimulation
timeFrame: Day 1
measure: Parasympathetic flexibility evolution during emotional recall
timeFrame: Day 1
measure: Sympathetic tone at rest
timeFrame: Day 1
measure: Corticotropic activation at rest
timeFrame: Day 1
measure: Mood disorders (anxiety / depression)
timeFrame: Day 1
measure: Post-traumatic stress disorder
timeFrame: Day 1
measure: Sleep quality
timeFrame: Day 1
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Groupement Hospitalier Régional de Mulhouse Sud Alsace
Study officials:
References: