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

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ClinicalTrials.gov Identifier: NCT04945837
Recruitment Status : Not yet recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
Regional Health Agency New Aquitaine
Région Nouvelle Aquitaine
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Covid19 Personnel, Hospital Work-Related Condition Work-Related Stress Disorder Other: self administered questionnaire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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

Primary Purpose: Other
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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in anxiety disorder overcome [ Time Frame: inclusion, month 1, month 3, month 6, month 12 ]

    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"


  2. Changes in anxiety disorder overcome [ Time Frame: 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 :
  1. Determination and collection of lived traumatic events types [ Time Frame: inclusion, month 1, month 3, month 6, month 12 ]
    Life Events Checklist for DSM-5 (LEC-5)

  2. Posttraumatic stress disorder symptoms presence and measurment [ Time Frame: 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)

  3. 2-last-week mood assessment [ Time Frame: 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

  4. Identification of coping pattern to stress [ Time Frame: 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

  5. Burn out diagnosis [ Time Frame: 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

  6. Self evaluation of state of health [ Time Frame: 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)

  7. Psycho active drugs intakes and level of intake over the last month [ Time Frame: 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"

  8. Evaluation of the CUMP support to health professionnals [ Time Frame: inclusion, month 1, month 3, month 6, month 12 ]
    answer "yes' or "no" support has been contacted already or since the last study assessement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04945837


Contacts
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Contact: Helen SAVARIEAU, MS +33 556 563 556 hsavarieau@ch-perrens.fr
Contact: Charles Henry MARTIN, MD +33 556 563 147 cmartin@ch-perrens.fr

Sponsors and Collaborators
Centre Hospitalier Charles Perrens, Bordeaux
Regional Health Agency New Aquitaine
Région Nouvelle Aquitaine
Publications of Results:
Other Publications:
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Responsible Party: Centre Hospitalier Charles Perrens, Bordeaux
ClinicalTrials.gov Identifier: NCT04945837    
Other Study ID Numbers: 2020-A02592-37
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Actually no sharing expected

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Charles Perrens, Bordeaux:
COVID-19
Mental health
Anxiety
Hospital personnel
Longitudinal
Pandemic
Additional relevant MeSH terms:
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COVID-19
Occupational Stress
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Occupational Diseases
Stress, Psychological
Behavioral Symptoms