Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area

Not Applicable

Not yet recruiting

• Conditions: Work-Related Condition; Covid19; Work-Related Stress Disorder; Personnel, Hospital
• Interventions: Other: self administered questionnaire

• Registration Number: NCT04945837
• Lead Sponsor: Centre Hospitalier Charles Perrens, Bordeaux

Brief Summary

Evaluation of the psychological impact of the COVID-19 pandemic on hospital staff in the French Nouvelle Aquitaine area, through a longitudinal study with repeated self-administered psychologic scales

Detailed Description

Evaluation of the psychological impact of Coronavirus disease 2019 (COVID-19) on hospital personnel in Nouvelle Aquitaine. IMPSY-COV Upon recent outbreaks of new diseases (SARS, MERS-CoV, Ebola) have led to the emergence of psychiatric disorders in healthcare workers , such as post-traumatic stress , anxiety (e.g., panic attacks) or depressive episodes. Observed similarities in between propagation patterns of SARS-CoV-2 and SARS, alow us to expect the occurence of similar psychiatric disorders in COVID-19 context to those described (Vignaud, Prieto, 2020). The study is set up to assess the psychological state of hospital personnel in the working conditions of treating COVID-19 suffering patients.

87000 hospital staff workers from the Nouvelle Aquitaine region will be invited to take part in the study. This includes medical and non-medical professionals from general and psychiatric hospitals exposed to COVID-19.

Study design. The protocol shows two phases and five measurement timepoints. In the initial phase (T0), eligible persons will be contacted via email. Those wishing to participate will then consent, answer socio-demographic questions and a series of psychology questionnaires. In the longitudinal phase, participants will be again invited to answer the same series of questionnaires four times: one month after the initial phase (T1), 3 months after (T2), 6 months after (T3) and 12 months after (T4).

Statistical analysis. In order to identify the consequences generated by COVID-19 in hospital personnel through a longitudinal protocol, several statistical analyses are considered, including logistic and linear regressions as well as ANOVA and MANOVA.

Expected outcomes. The study will assess the occurrence and the evolution of psychological distress and identify vulnerability factors that may trigger psychiatric disorders in these situations. The study will also provide an opportunity to improve the supporting actions of professionals affected by the crisis.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Study Start: 2022-09
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

• 18 years or more
• hospital workers exposed to COVID-19
• consented to participate to the study
• master the french langage
• Understanding of type, objectives and study methology
• accept an on-line evaluation
• Benefit from health insurance

Exclusion Criteria

• refuse to participate
• pregnant or breastfeeding woman
• Be under measure of legal protection: guardianship, curatorship or safeguard of justice.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
unique study arm	self administered questionnaire	Initial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires

Primary Outcome Measures

Name	Time	Method
Changes in anxiety disorder overcome	inclusion, month 1, month 3, month 6, month 12	PDSR verifies that maximum of the panic state is reached within ten minutes

Secondary Outcome Measures

Name	Time	Method
Determination and collection of lived traumatic events types	inclusion, month 1, month 3, month 6, month 12	Life Events Checklist for DSM-5 (LEC-5)
Burn out diagnosis	inclusion, month 1, month 3, month 6, month 12	MASLACH BURNOUT INVENTORY (MBI questionnaire) assessment of the 3 aspects from low to high; * burn out feeling; * deshumanisation; * accomplishment at work
Evaluation of the CUMP support to health professionnals	inclusion, month 1, month 3, month 6, month 12	answer "yes' or "no" support has been contacted already or since the last study assessement
Posttraumatic stress disorder symptoms presence and measurment	inclusion, month 1, month 3, month 6, month 12	Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) PCL-5 score \> 32 indicate presence of Posttraumatic Stress Trouble (PST)
2-last-week mood assessment	inclusion, month 1, month 3, month 6, month 12	Beck Depression Inventory - Fast Screen - France (BDI-FS FR) score \> 13 indicates presence of a depressive trouble
Self evaluation of state of health	inclusion, month 1, month 3, month 6, month 12	considering the 4-last-weeks the participant will assess 8 under-scales for score 0 to 100 (favourable)
Identification of coping pattern to stress	inclusion, month 1, month 3, month 6, month 12	Coping Inventory for Stressful Situations (CISS) questionnaire Participant assess from 'little" to "a lot" his tendency to adopt a task, emotion or behaviour based pattern
Psycho active drugs intakes and level of intake over the last month	inclusion, month 1, month 3, month 6, month 12	selection of the drug and level of intake will n\*be assessed 'none', "new", "increasing", constant"