Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area (IMPSY-COV)

Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area : a Prospective Longitudinal Study by Self-administered Questionnaires

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

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19; Work-Related Condition; Work-Related Stress Disorder; Personnel, Hospital
• Intervention / Treatment: Other: self administered questionnaire

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 Type: Interventional
• Enrollment (Anticipated): 8000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen SAVARIEAU, MS; Phone Number: +33 556 563 556; Email: hsavarieau@ch-perrens.fr
• Study Contact Backup: Name: Charles Henry MARTIN, MD; Phone Number: +33 556 563 147; Email: cmartin@ch-perrens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: unique study arm; Initial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires	Other: self administered questionnaire; longitunidal descriptive study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety disorder overcome	GAD-7 score: > 7 , the anxiety disorder status is "supected", [5; 9] corresponds to anxiety evaluation: "light" [10; 14] corresponds to anxiety evaluation: "moderate" > 15, corresponds to anxiety evaluation: "severe"	inclusion, month 1, month 3, month 6, month 12
Changes in anxiety disorder overcome	PDSR verifies that maximum of the panic state is reached within ten minutes	inclusion, month 1, month 3, month 6, month 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Charles Perrens, Bordeaux
• Collaborators: Région Nouvelle Aquitaine; Regional Health Agency New Aquitaine

Publications and helpful links

General Publications

• Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.
• Mohammed A, Sheikh TL, Poggensee G, Nguku P, Olayinka A, Ohuabunwo C, Eaton J. Mental health in emergency response: lessons from Ebola. Lancet Psychiatry. 2015 Nov;2(11):955-7. doi: 10.1016/S2215-0366(15)00451-4. No abstract available.
• Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.
• Chua SE, Cheung V, Cheung C, McAlonan GM, Wong JW, Cheung EP, Chan MT, Wong MM, Tang SW, Choy KM, Wong MK, Chu CM, Tsang KW. Psychological effects of the SARS outbreak in Hong Kong on high-risk health care workers. Can J Psychiatry. 2004 Jun;49(6):391-3. doi: 10.1177/070674370404900609.
• Johnson EI, Grondin O, Barrault M, Faytout M, Helbig S, Husky M, Granholm EL, Loh C, Nadeau L, Wittchen HU, Swendsen J. Computerized ambulatory monitoring in psychiatry: a multi-site collaborative study of acceptability, compliance, and reactivity. Int J Methods Psychiatr Res. 2009;18(1):48-57. doi: 10.1002/mpr.276.
• Luceno-Moreno L, Talavera-Velasco B, Garcia-Albuerne Y, Martin-Garcia J. Symptoms of Posttraumatic Stress, Anxiety, Depression, Levels of Resilience and Burnout in Spanish Health Personnel during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Jul 30;17(15):5514. doi: 10.3390/ijerph17155514.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; COVID-19; Mental health; Longitudinal; Pandemic; Hospital personnel
• Additional Relevant MeSH Terms: Behavioral Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stress, Psychological; Occupational Diseases; COVID-19; Occupational Stress
• Other Study ID Numbers: 2020-A02592-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Actually no sharing expected

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No