Covid19IMPSY-COVNCT04945837
Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area
A study testing self administered questionnaire in people with Covid19 and Personnel, Hospital, run by Centre Hospitalier Charles Perrens, Bordeaux.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Personnel, Hospital, Work-Related Condition
- What is being tested?
- self administered questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- refuse to participate
- pregnant or breastfeeding woman
- Be under measure of legal protection: guardianship, curatorship or safeguard of justice.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Being tested
- self administered questionnaire
- Keywords
- COVID-19, Mental health, Anxiety, Hospital personnel, Longitudinal, Pandemic
- Medical subject headings
- COVID-19, Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self administered questionnaireOther
longitunidal descriptive study
| Study group | Role | What they receive |
|---|---|---|
| unique study arm | Other | Initial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires Receives: Other: self administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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
Measured: inclusion, month 1, month 3, month 6, month 12
Secondary outcomes (8)
Determination and collection of lived traumatic events types
Life Events Checklist for DSM-5 (LEC-5)
Measured: inclusion, month 1, month 3, month 6, month 12
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)
Measured: inclusion, month 1, month 3, month 6, month 12
2-last-week mood assessment
Beck Depression Inventory - Fast Screen - France (BDI-FS FR) score > 13 indicates presence of a depressive trouble
Measured: inclusion, month 1, month 3, month 6, month 12
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
Measured: inclusion, month 1, month 3, month 6, month 12
Burn out diagnosis
MASLACH BURNOUT INVENTORY (MBI questionnaire) assessment of the 3 aspects from low to high
- burn out feeling
- deshumanisation
- accomplishment at work
Measured: inclusion, month 1, month 3, month 6, month 12
Self evaluation of state of health
considering the 4-last-weeks the participant will assess 8 under-scales for score 0 to 100 (favourable)
Measured: inclusion, month 1, month 3, month 6, month 12
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"
Measured: inclusion, month 1, month 3, month 6, month 12
Evaluation of the CUMP support to health professionnals
answer "yes' or "no" support has been contacted already or since the last study assessement
Measured: inclusion, month 1, month 3, month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study startSep 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Longitudinal Study by Self-administered Questionnaires
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Collaborators
- Regional Health Agency New Aquitaine, Région Nouvelle Aquitaine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945837
- Sponsor's protocol ID
- 2020-A02592-37
- Acronym
- IMPSY-COV
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Actually no sharing expected
Publications
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.
PubMed 15283534Greenberg 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.
PubMed 32217624Johnson 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.
PubMed 19195050Luceno-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.
PubMed 32751624Mohammed 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.
PubMed 26544738Chan 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.
PubMed 15133143
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04945837
- Acronym / sponsor ID
- IMPSY-COV / 2020-A02592-37
- Keywords
- COVID-19, Mental health, Anxiety, Hospital personnel, Longitudinal, Pandemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Collaborators
- Regional Health Agency New Aquitaine, Région Nouvelle Aquitaine
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Longitudinal Study by Self-administered Questionnaires
| Arm | Type | Receives |
|---|---|---|
| unique study arm | Other | Other: self administered questionnaireInitial socio-demographic questionnaire 5 timepoints psychologic and self-administered questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- refuse to participate
- pregnant or breastfeeding woman
- Be under measure of legal protection: guardianship, curatorship or safeguard of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self administered questionnairelongitunidal descriptive study | Other | unique study arm |
Primary outcome
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"
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
8 secondary outcomes
Determination and collection of lived traumatic events types
Time frame: inclusion, month 1, month 3, month 6, month 12
Posttraumatic stress disorder symptoms presence and measurment
Time frame: inclusion, month 1, month 3, month 6, month 12
2-last-week mood assessment
Time frame: inclusion, month 1, month 3, month 6, month 12
Identification of coping pattern to stress
Time frame: inclusion, month 1, month 3, month 6, month 12
Burn out diagnosis
Time frame: inclusion, month 1, month 3, month 6, month 12
Self evaluation of state of health
Time frame: inclusion, month 1, month 3, month 6, month 12
Psycho active drugs intakes and level of intake over the last month
Time frame: inclusion, month 1, month 3, month 6, month 12
Evaluation of the CUMP support to health professionnals
Time frame: inclusion, month 1, month 3, month 6, month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 15283534Chua 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.
- Background: PubMed 32217624Greenberg 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.
- Background: PubMed 19195050Johnson 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.
- Background: PubMed 32751624Luceno-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 publication: PubMed 26544738Mohammed 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 publication: PubMed 15133143Chan 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.
- Individual participant dataSharing planned: No. Actually no sharing expected
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing self administered questionnaire in people with Covid19 and Personnel, Hospital, run by Centre Hospitalier Charles Perrens, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen SAVARIEAU, MS (+33 556 563 556, hsavarieau@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anxiety disorder overcome (time frame: inclusion, month 1, month 3, month 6, month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945837, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.