Covid19PSIMCOVNCT04506515
Psychological Impact of COVID-19 Pandemic in Healthcare Workers
An observational study of Covid19 and Stress, Psychological, run by Hospital General Universitario de Valencia at 1 site in Spain.
Trial summary
Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited. Methods. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19, Stress, Psychological, Work Related Stress
- What is being tested?
- Psychological stress and adaptation at work score (PSAS)
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2020to 30 Apr 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
- Adult, Older adult
Study population: Respondents are healthcare workers in any center/hospital treating patients and are involved directly or indirectily with patients who suffer from COVID-19. Respondents might be physicians, nurses, ancillary staff, etc or be involved in other type of jobs like administration, techinical support, kitchen and cleaning servicies, etc.
Who may be able to join
- Active healthcare workers in any private/public hospital > 18 years old
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group
Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited.
Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.
Read the detailed description
PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire designed to assess psychological impact in healthcare workers to match times of crisis and when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent higher stress detected.
- Being tested
- Psychological stress and adaptation at work score (PSAS)
- Medical subject headings
- COVID-19, Stress, Psychological, Occupational Stress, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological stress and adaptation at work score (PSAS)Diagnostic test
completing a survey based on PSAS
What is being measured
The primary outcome is the main question the study is designed to answer.
PSAS (Psychological Stress and Adaptation at work Score) during the crisis
evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers
Measured: during the pandemic (April 9, 2020 to April 19, 2020)
Secondary outcomes (1)
PSAS (Psychological Stress and Adaptation at work Score) in basal conditions
evaluate the psychological stress in Spain in healthcare workers
Measured: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start9 Apr 2020
- Primary completion19 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Soledad Romero Garcia, MD, PhD, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506515
- Sponsor's protocol ID
- COV2-2020
- Acronym
- PSIMCOV
- Status last verified
- Nov 2021
- First submitted
- 3 Aug 2020
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators did not ask to the ethical committee board for data sharing approval
Publications
Romero CS, Delgado C, Catala J, Ferrer C, Errando C, Iftimi A, Benito A, de Andres J, Otero M; PSIMCOV group*. COVID-19 psychological impact in 3109 healthcare workers in Spain: The PSIMCOV group. Psychol Med. 2022 Jan;52(1):188-194. doi: 10.1017/S0033291720001671. Epub 2020 May 14.
PubMed 32404217
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group
- ClinicalTrials.gov ID
- NCT04506515
- Acronym / sponsor ID
- PSIMCOV / COV2-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Hospital General Universitario de ValenciaUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 10 Aug 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.
Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited.
Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.
Detailed description
PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire designed to assess psychological impact in healthcare workers to match times of crisis and when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent higher stress detected.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Respondents are healthcare workers in any center/hospital treating patients and are involved directly or indirectily with patients who suffer from COVID-19. Respondents might be physicians, nurses, ancillary staff, etc or be involved in other type of jobs like administration, techinical support, kitchen and cleaning servicies, etc.
Key inclusion criteria (1 listed)
- Active healthcare workers in any private/public hospital > 18 years old
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Psychological stress and adaptation at work score (PSAS)completing a survey based on PSAS | Diagnostic test | – |
Primary outcome
PSAS (Psychological Stress and Adaptation at work Score) during the crisis
Time frame: during the pandemic (April 9, 2020 to April 19, 2020)
evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers
1 secondary outcome
PSAS (Psychological Stress and Adaptation at work Score) in basal conditions
Time frame: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
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 10 Nov 2021.
- Background: PubMed 32404217Romero CS, Delgado C, Catala J, Ferrer C, Errando C, Iftimi A, Benito A, de Andres J, Otero M; PSIMCOV group*. COVID-19 psychological impact in 3109 healthcare workers in Spain: The PSIMCOV group. Psychol Med. 2022 Jan;52(1):188-194. doi: 10.1017/S0033291720001671. Epub 2020 May 14.
- Individual participant dataSharing planned: Undecided. The investigators did not ask to the ethical committee board for data sharing approval
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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.
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 Covid19 and Stress, Psychological, run by Hospital General Universitario de Valencia at 1 site in Spain.
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: finished, as of the sponsor's last update on 10 Nov 2021. 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 Spain. 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?
PSAS (Psychological Stress and Adaptation at work Score) during the crisis (time frame: during the pandemic (April 9, 2020 to April 19, 2020)). 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 NCT04506515, which also lists 1 linked publication.
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 10 Nov 2021.