Clinical trial NCT04945837: Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area
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
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Personnel, Hospital
Work-Related Condition
Work-Related Stress Disorder
Keywords: COVID-19
Mental health
Anxiety
Hospital personnel
Longitudinal
Pandemic
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
Collaborators: name: Regional Health Agency New Aquitaine
name: Région Nouvelle Aquitaine
First posted: 2021-06-30
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Longitudinal Study by Self-administered Questionnaires
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in anxiety disorder overcome
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Changes in anxiety disorder overcome
timeFrame: inclusion, month 1, month 3, month 6, month 12
Secondary outcomes:
measure: Determination and collection of lived traumatic events types
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Posttraumatic stress disorder symptoms presence and measurment
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: 2-last-week mood assessment
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Identification of coping pattern to stress
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Burn out diagnosis
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Self evaluation of state of health
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Psycho active drugs intakes and level of intake over the last month
timeFrame: inclusion, month 1, month 3, month 6, month 12
measure: Evaluation of the CUMP support to health professionnals
timeFrame: inclusion, month 1, month 3, month 6, month 12
Other outcomes:
Locations:
Study officials:
References:
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.
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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.
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.
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.