NCT04945837

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

June 21, 2021

Last Update Submit

July 19, 2022

Conditions

Keywords

COVID-19Mental healthAnxietyHospital personnelLongitudinalPandemic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Determination and collection of lived traumatic events types

    inclusion, month 1, month 3, month 6, month 12

  • Posttraumatic stress disorder symptoms presence and measurment

    inclusion, month 1, month 3, month 6, month 12

  • 2-last-week mood assessment

    inclusion, month 1, month 3, month 6, month 12

  • Identification of coping pattern to stress

    inclusion, month 1, month 3, month 6, month 12

  • Burn out diagnosis

    inclusion, month 1, month 3, month 6, month 12

  • +3 more secondary outcomes

Study Arms (1)

unique study arm

OTHER

Initial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires

Other: self administered questionnaire

Interventions

longitunidal descriptive study

unique study arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 15283534BACKGROUND
  • 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.

    PMID: 32217624BACKGROUND
  • 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.

    PMID: 19195050BACKGROUND
  • 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.

    PMID: 32751624BACKGROUND
  • 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.

MeSH Terms

Conditions

COVID-19Psychological Well-BeingAnxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehaviorMental Disorders

Central Study Contacts

Helen SAVARIEAU, MS

CONTACT

Charles Henry MARTIN, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Data anonymisation: Participant timepoints data are identified and followed up through a token number
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective Longitudinal Study by Self-administered Questionnaires
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 30, 2021

Study Start

September 1, 2022

Primary Completion

January 1, 2024

Study Completion

December 1, 2024

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Actually no sharing expected