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Completed

NCT Number: NCT05033223

Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services

The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.

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Key information

Conditions

Post Traumatic Stress Disorder Behavior Behavioral Symptoms Burnout, Psychological COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress, Psychological Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Accueil des Urgences

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults
  • Administrative and technical medical staff of the Hospices Civils de Lyon
  • Contractual or holder
  • Having participated in the COVER PRO study
  • Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
  • Affiliated with a social security system
  • Having signed an informed consent

Exclusion criteria

  • Refusal to participate
  • Major under legal protection

Treatment and study plan

PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic

Other

PCL-5 autoquestionnaire to make the PTSD diagnosis

Primary outcomes

  1. Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale

    Time frame: 12 months after the end of the second Lockdown (December 2020)

    : Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life

Secondary outcomes

  1. Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale

    Time frame: 9months after the end of the second Lockdown (December 2020)

    Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life

  2. Anxiety evaluation at 12 months using HAD scale

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder

  3. Anxiety evaluation at 9 months using HAD scale

    Time frame: 9months after the end of the second Lockdown (December 2020)

    Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder

  4. Depression evaluation at 12 months using HAD scale

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder

  5. Depression evaluation at 9 months using HAD scale

    Time frame: 9months after the end of the second Lockdown (December 2020)

    Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder

  6. Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Burnout characterized by the Maslach burnout inventory scale. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout.

  7. Presence of a Burn out at 9 months using the MBI scale

    Time frame: 9months after the end of the second Lockdown (December 2020)

    Burnout characterized by the Maslach burnout inventory scale. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout.

  8. Work-related stress measured using Karasek questionnaire at 12 months

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Work-related stress measured using Karasek questionnaire at 12 months

  9. Work-related stress measured using Karasek questionnaire at 9 months

    Time frame: 9months after the end of the second Lockdown (December 2020)

    Work-related stress measured using Karasek questionnaire at 9 months

  10. Consumption of psychoactive substances at 12 months

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Change in the consumption of psychoactive substances at 12 months

  11. Percentage of patients with psychological Support at 12 months

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Percentage of patients who benefit from a psychological support at 12 months

  12. Mean number of days of sick leave at 12 months

    Time frame: 12months after the end of the second Lockdown (December 2020)

    Mean number of days of sick leave at 12 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)

Acronym: COVER PRO LT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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