COVIDNCT04424771
Post-traumatic Stress Disease in Health Workers During COVID-19 Pandemia
An observational study of COVID and Post Traumatic Stress Disorder, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 2 sites in Italy.
Trial summary
The purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID, Post Traumatic Stress Disorder
- What is being tested?
- Maslach Burnout Inventory (MBI)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2020to 1 Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population consisted of workers in health services.
Who may be able to join
- workers in health services, including phisicians, nurses, inhospital technicians and biologists
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale Perrino Asl Brindisi
Brindisi
Piazza della Vittoria 14 Studio medico - Ginecologia e Ostetricia
Genoa, 16121
About this study
Official title: PTSD in Health Workers During COVID-19 Pandemia
The purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.
- Conditions
- COVID, Post Traumatic Stress Disorder
- Being tested
- Maslach Burnout Inventory (MBI)
- Keywords
- COVID-19
- Medical subject headings
- Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maslach Burnout Inventory (MBI)Behavioural
The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout.
| Study group | Role | What they receive |
|---|---|---|
| Health workers | They include doctors, nurses, techinicians, biologists and other non technical inhospital workers Receives: Behavioral: Maslach Burnout Inventory (MBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with diagnosis of PTSD.
PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.
Measured: Through study completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424771
- Sponsor's protocol ID
- PTSD-COVID-19
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD in Health Workers During COVID-19 Pandemia
- ClinicalTrials.gov ID
- NCT04424771
- Acronym / sponsor ID
- PTSD-COVID-19
- Conditions
- COVID, Post Traumatic Stress Disorder
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Jun 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 purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health workers | – | Behavioral: Maslach Burnout Inventory (MBI)They include doctors, nurses, techinicians, biologists and other non technical inhospital workers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consisted of workers in health services.
Key inclusion criteria (1 listed)
- workers in health services, including phisicians, nurses, inhospital technicians and biologists
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Maslach Burnout Inventory (MBI)The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout. | Behavioural | Health workers |
Primary outcome
Number of patients with diagnosis of PTSD.
Time frame: Through study completion, an average of 1 months
PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Post Traumatic Stress Disorder, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 2 sites in Italy.
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 0 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: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with diagnosis of PTSD. (time frame: Through study completion, an average of 1 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 27 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.