Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Burnout, Professional
  • Depression
  • Post Traumatic Stress Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Trials Within Cohort (TWIC) : Participants are included within a cohort. They are screened using an online self-administered questionnaire for psychological distress (Post-Traumatic Stress Disorder, Burnout, Depression) every three months for one year. People who are positive after screening (at M0 or M3 or M6) will be eligible for the trial and some of them will be randomly assigned to the treatment group. The rest of the cohort will be the second arm (control group).Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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: / 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. / 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) .

Tracking Information

NCT #
NCT04570202
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Wissam EL-HAGE, MD-PhD University Hospital of TOURS