Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area (IMPSY-COV)
Primary Purpose
Covid19, Personnel, Hospital, Work-Related Condition
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
self administered questionnaire
Sponsored by
About this trial
This is an interventional other trial for Covid19 focused on measuring COVID-19, Mental health, Anxiety, Hospital personnel, Longitudinal, Pandemic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
unique study arm
Arm Description
Initial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires
Outcomes
Primary Outcome Measures
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"
Changes in anxiety disorder overcome
PDSR verifies that maximum of the panic state is reached within ten minutes
Secondary Outcome Measures
Determination and collection of lived traumatic events types
Life Events Checklist for DSM-5 (LEC-5)
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)
2-last-week mood assessment
Beck Depression Inventory - Fast Screen - France (BDI-FS FR) score > 13 indicates presence of a depressive trouble
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
Burn out diagnosis
MASLACH BURNOUT INVENTORY (MBI questionnaire) assessment of the 3 aspects from low to high
burn out feeling
deshumanisation
accomplishment at work
Self evaluation of state of health
considering the 4-last-weeks the participant will assess 8 under-scales for score 0 to 100 (favourable)
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"
Evaluation of the CUMP support to health professionnals
answer "yes' or "no" support has been contacted already or since the last study assessement
Full Information
NCT ID
NCT04945837
First Posted
June 21, 2021
Last Updated
July 19, 2022
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Collaborators
Regional Health Agency New Aquitaine, Région Nouvelle Aquitaine
1. Study Identification
Unique Protocol Identification Number
NCT04945837
Brief Title
Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area
Acronym
IMPSY-COV
Official Title
Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area : a Prospective Longitudinal Study by Self-administered Questionnaires
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Collaborators
Regional Health Agency New Aquitaine, Région Nouvelle Aquitaine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Personnel, Hospital, Work-Related Condition, Work-Related Stress Disorder
Keywords
COVID-19, Mental health, Anxiety, Hospital personnel, Longitudinal, Pandemic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Longitudinal Study by Self-administered Questionnaires
Masking
None (Open Label)
Masking Description
Data anonymisation:
Participant timepoints data are identified and followed up through a token number
Allocation
N/A
Enrollment
8000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
unique study arm
Arm Type
Other
Arm Description
Initial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires
Intervention Type
Other
Intervention Name(s)
self administered questionnaire
Intervention Description
longitunidal descriptive study
Primary Outcome Measure Information:
Title
Changes in anxiety disorder overcome
Description
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"
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Changes in anxiety disorder overcome
Description
PDSR verifies that maximum of the panic state is reached within ten minutes
Time Frame
inclusion, month 1, month 3, month 6, month 12
Secondary Outcome Measure Information:
Title
Determination and collection of lived traumatic events types
Description
Life Events Checklist for DSM-5 (LEC-5)
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Posttraumatic stress disorder symptoms presence and measurment
Description
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) PCL-5 score > 32 indicate presence of Posttraumatic Stress Trouble (PST)
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
2-last-week mood assessment
Description
Beck Depression Inventory - Fast Screen - France (BDI-FS FR) score > 13 indicates presence of a depressive trouble
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Identification of coping pattern to stress
Description
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
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Burn out diagnosis
Description
MASLACH BURNOUT INVENTORY (MBI questionnaire) assessment of the 3 aspects from low to high
burn out feeling
deshumanisation
accomplishment at work
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Self evaluation of state of health
Description
considering the 4-last-weeks the participant will assess 8 under-scales for score 0 to 100 (favourable)
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Psycho active drugs intakes and level of intake over the last month
Description
selection of the drug and level of intake will n*be assessed 'none', "new", "increasing", constant"
Time Frame
inclusion, month 1, month 3, month 6, month 12
Title
Evaluation of the CUMP support to health professionnals
Description
answer "yes' or "no" support has been contacted already or since the last study assessement
Time Frame
inclusion, month 1, month 3, month 6, month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen SAVARIEAU, MS
Phone
+33 556 563 556
Email
hsavarieau@ch-perrens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Henry MARTIN, MD
Phone
+33 556 563 147
Email
cmartin@ch-perrens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Actually no sharing expected
Citations:
PubMed Identifier
15283534
Citation
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.
Results Reference
background
PubMed Identifier
32217624
Citation
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.
Results Reference
background
PubMed Identifier
19195050
Citation
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.
Results Reference
background
PubMed Identifier
32751624
Citation
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.
Results Reference
background
PubMed Identifier
26544738
Citation
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.
Results Reference
result
PubMed Identifier
15133143
Citation
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.
Results Reference
result
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Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area
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