Post Traumatic Stress Disorder (PTSD)Covid-ImpactNCT04558437
COVID-Impact "Psychological IMPACT of Covid-19 on AP-HP Staff"
An observational study of Post Traumatic Stress Disorder (PTSD) and Anxiety, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD), Anxiety, Depression
- What is being tested?
- Questionnaire
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 31 Dec 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Care teams and supports of AP-HP hospitals
Who may be able to join
- AP-HP professionals on duty during the COVID epidemic agreeing to participate in the three stages of the study.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris
Paris, Île-de-France Region
Isabelle Vivaldo, isabelle.vivaldo@aphp.fr
Pierre-André Natella, PharmD, pierre.natella@aphp.fr
About this study
Official title: Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic
The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.
- Being tested
- Questionnaire
- Keywords
- prevalence, post-traumatic stress disorder (PTSD),, epidemic, COVID19
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, COVID-19, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire at M0 M3 M6:
PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) HAD (Hospital Anxiety and Depression Scale) SDS (Sheehan Disability Scales)
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months).
Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)
Measured: 6 months
Secondary outcomes (2)
Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months).
Rate of respondents with an Anxiety Disorder defined as score higher or equal to 8 for the HAD-A subscale (Hospital Anxiety and Depression - Anxiety subscale) independently at each measure (inclusion, M3 and M6)
Measured: baseline, 3 months and 6 months
Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6).
Rate of respondents with a Depressive Disorder defined as score higher or equal to 8 for the HAD-D subscale (Hospital Anxiety and Depression - Depression subscale) independently at each measure (inclusion, M3 and M6)
Measured: baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start12 Jun 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558437
- Sponsor's protocol ID
- APHP200555
- Acronym
- Covid-Impact
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic
- ClinicalTrials.gov ID
- NCT04558437
- Acronym / sponsor ID
- Covid-Impact / APHP200555
- Keywords
- prevalence, post-traumatic stress disorder (PTSD),, epidemic, COVID19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Sep 2020 (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.
The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Care teams and supports of AP-HP hospitals
Key inclusion criteria (1 listed)
- AP-HP professionals on duty during the COVID epidemic agreeing to participate in the three stages of the study.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| QuestionnaireQuestionnaire at M0 M3 M6: PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) HAD (Hospital Anxiety and Depression Scale) SDS (Sheehan Disability Scales) | Other | – |
Primary outcome
Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months).
Time frame: 6 months
Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)
2 secondary outcomes
Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months).
Time frame: baseline, 3 months and 6 months
Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6).
Time frame: baseline, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder (PTSD) and Anxiety, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 1 inclusion and 1 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Antoine PELISSOLO, MD-PhD (01 49 81 31 75 ext. +33, antoine.pelissolo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2020.