COVID-Impact "Psychological IMPACT of Covid-19 on AP-HP Staff"

Depression Clinical Trial

— Covid-Impact  

Official title:

Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558437
• Other study ID #: APHP200555
• Status: Recruiting
• Start date: June 12, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Antoine PELISSOLO, MD-PhD
• Phone: 01 49 81 31 75
• Email: antoine.pelissolo[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AP-HP professionals on duty during the COVID epidemic agreeing to participate in the three stages of the study.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Anxiety
• COVID19
• Depression
• Epidemic Disease
• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Questionnaire
Questionnaire at M0 M3 M6: PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) HAD (Hospital Anxiety and Depression Scale) SDS (Sheehan Disability Scales)

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months).	Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)	6 months
Secondary	Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months).	Rate of respondents with an Anxiety Disorder defined as score higher or equal to 8 for the HAD-A subscale (Hospital Anxiety and Depression - Anxiety subscale) independently at each measure (inclusion, M3 and M6)	baseline, 3 months and 6 months
Secondary	Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6).	Rate of respondents with a Depressive Disorder defined as score higher or equal to 8 for the HAD-D subscale (Hospital Anxiety and Depression - Depression subscale) independently at each measure (inclusion, M3 and M6)	baseline, 3 months and 6 months