Health cAre woRkers exposeD to COVID-19

  • STATUS
    Recruiting
  • End date
    Aug 20, 2022
  • participants needed
    900
  • sponsor
    University Hospital, Tours
Updated on 28 March 2021

Summary

Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making.

Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19.

This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

Description

Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making. Preliminary data from China suggests that frontline and lay professionals suffer from different types of psychological distress. A study of the mental health of 230 frontline medical staff in the COVID-19 outbreak found a high prevalence of anxiety and stress disorder (up to 25%).

These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as EMDR (desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19. EMDR is a therapy which for nearly 30 years has demonstrated, through well-conducted international experimental studies with a high level of evidence including a recent meta-analysis from 2019, its effectiveness in the treatment of post-traumatic stress disorder and depression. Its use is recommended by the French National Authority for Health and the World Health Organization. In France, more than 1,700 therapists practice it. While the evidence for the effectiveness of EMDR is strong and its feasibility adapted to a crisis such as the COVID-19 pandemic, its use has not been evaluated at the population level in the context of an exceptional health crisis.

This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

In addition, this project is also built to allow health professionals involved in the fight against COVID-19 to have regular access to self-administered screening with immediate feedback concerning the most frequent psychological symptoms, this method of screening and monitoring psychological distress in the context of a pandemic is not currently implemented in France.

The objectives of the study are as follows:

  1. / Create a cohort of French hospital health-care workers and French health professionals working in nursing home for elderly people involved in the care of COVID-19 patients in which we will:
    • offer a self-administered mass screening test for common psychiatric disorders likely to occur in this context, and estimate the frequency of occurrence of common psychological symptoms in the short and long term (depression, burnout, post-traumatic stress);
    • estimate the evolution over a year of the aforementioned symptoms and try to explain these trajectories.
  2. / To evaluate, in a randomized controlled trial, the effectiveness of 12 sessions of a specific therapeutic intervention combining "EMDR + usual care" compared to "usual care" alone in eligible participants (those screened positive for psychological symptoms) .

Details
Condition Endogenous depression, Depression, Post-Traumatic Stress Disorder, Burnout, Professional, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Post-Traumatic Stress Disorders, Depression (Treatment-Resistant), Depressed, depressive disorder, PTSD, depressed mood, miserable, depressive disorders
Treatment EMDR
Clinical Study IdentifierNCT04570202
SponsorUniversity Hospital, Tours
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Depression (Treatment-Resistant) or Post-Traumatic Stress Disorder or Depression (Major/Severe) or Depression (Adult and Geriatric) or Depression or D...?
Do you have any of these conditions: Depression (Major/Severe) or Post-Traumatic Stress Disorders or depressed mood or Post-Traumatic Stress Disorder or Depressed or depressive disorder o...?
Do you have any of these conditions: miserable or Depression (Major/Severe) or Depression or Endogenous depression or Depression (Pediatric) or Burnout, Professional or Post-Traumatic Str...?
Do you have any of these conditions: Depression (Treatment-Resistant) or Depression or Depression (Adult and Geriatric) or depressed mood or depressive disorders or Depression (Adolescent...?
Do you have any of these conditions: Depression or depressed mood or Depression (Treatment-Resistant) or Burnout, Professional or depressive disorder or Depressed or Depression (Major/Sev...?
years of age
French speaking
Health care workers: physicians, residents in medicine or pharmacy, dentist residents, nurses, auxiliary nurses, pharmacist, dentist, midwife, physiotherapists, radiographers, ambulance attendants, hospital porters, medical students, pharmacy students, dentist students, midwife students, nursing students, auxiliary nursing students, physiotherapist students, radiographer students
Working in metropolitan French public or private hospitals or in nursing home for elderly people (in French: "Etablissements d'Hbergement pour Personnes Ages Dpendantes" (EHPAD))
Have taken care of patients with COVID-19
Participants covered by or entitled to social security
Written informed consent obtained from the participant
Ability for participant to comply with the requirements of the study
Inclusion criteria in the EMDR trial
Participant involved in the cohort study
Participant who are screened positive for PTSD ( 40 on PCL-5), depression ( 15 on PHQ-9), or on one of the burnout dimensions ( 22 on compassion satisfaction dimension, 42 on burnout dimension, or 42 on compassion fatigue dimension, as measured using the ProQOL) at M0 or M3 or M6

Exclusion Criteria

none
Exclusion criteria in the EMDR trial
none
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note