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Covid19COVID-TRUSTNCT04517136

Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions

An observational study of Covid19 and SARS-CoV Infection, run by Direction Centrale du Service de Santé des Armées at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Covid19, SARS-CoV Infection, Burnout, Caregiver
What is being tested?
Assessment of work-related stress, Saliva sample collection and Cardiac and electrodermal recordings
How many people
39 participants
Where
1 siteFrance
Study dates
14 Sep 2020to Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupement Hospitalier Régional de Mulhouse Sud Alsace

    Mulhouse, 68100

Other trials in France

About this study

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.

Read more

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.

Being tested
Assessment of work-related stress, Saliva sample collection, Cardiac and electrodermal recordings, Assessment of behavioral response to emotional stimulation
Medical subject headings
COVID-19, Severe Acute Respiratory Syndrome, Caregiver Burden, Burnout, Professional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of work-related stressBehavioural

    Assessment of burnout, mindfulness, interoceptive awareness, anxiety, post-traumatic stress disorder, coping flexibility and sleep through questionnaires.

  • Saliva sample collectionBiological

    Saliva sample is collected before and after emotional stimulation in order to measure resting-state allostatic load biomarkers: Dehydroepiandrosterone (DHEA), cortisol and chromogranin A levels

  • Cardiac and electrodermal recordingsDevice

    Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.

  • Assessment of behavioral response to emotional stimulationBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 21 days after enrollment (Day 21)

  2. 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).

    Measured: Day 1

Secondary outcomes (7)
  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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

    Measured: Day 1

  4. Corticotropic activation at rest

    Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio

    Measured: Day 1

  5. 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 characterized anxiety/depression.

    Measured: Day 1

  6. Post-traumatic stress disorder

    Post-traumatic disorder is assessed with the PTSD Checklist (PCL-5). It is a 20-item self-administered questionnaire representing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Post-traumatic stress disorder (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.

    Measured: Day 1

  7. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2020
  2. Study start14 Sep 2020
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04517136
Sponsor's protocol ID
2020-COVID19-28
Other IDs
2020-A01937-32
Acronym
COVID-TRUST
Status last verified
Feb 2022
First submitted
15 Aug 2020
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and SARS-CoV Infection, run by Direction Centrale du Service de Santé des Armées at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Professional burnout (time frame: 21 days after enrollment (Day 21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.

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