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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
Centre Hospitalier Charles Perrens, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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