Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area

NCT ID: NCT04945837

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Personnel, Hospital Work-Related Condition Work-Related Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Longitudinal Study by Self-administered Questionnaires
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Data anonymisation:

Participant timepoints data are identified and followed up through a token number

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

unique study arm

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

Group Type OTHER

self administered questionnaire

Intervention Type OTHER

longitunidal descriptive study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

self administered questionnaire

longitunidal descriptive study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regional Health Agency New Aquitaine

OTHER_GOV

Sponsor Role collaborator

Région Nouvelle Aquitaine

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Charles Perrens, Bordeaux

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Helen SAVARIEAU, MS

Role: CONTACT

+33 556 563 556

Charles Henry MARTIN, MD

Role: CONTACT

+33 556 563 147

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15283534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32217624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19195050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32751624 (View on PubMed)

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.

Reference Type RESULT
PMID: 26544738 (View on PubMed)

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.

Reference Type RESULT
PMID: 15133143 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A02592-37

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.