Distress, EmotionalBE-STRONGNCT04890600
COVID-19 and Psycological Well-being in Healthcare Workers
An observational study of Distress, Emotional and Coping Behavior, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19. After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distress, Emotional, Coping Behavior
- What is being tested?
- well-being assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 Apr 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: nurses, medical doctors, therapists, researchers, administrative workers
Who may be able to join
- Healthworkers of San Raffaele Institution
- age>18
Who cannot join
- all those who do not agree
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on Psycological Well-being in Healthcare Workers of San Raffaele Institution During COVID-19 Emergency Context
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.
After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules.
No personal data are required.
Read the detailed description
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.
Data will be analysed to investigate levels of resilience in healthworkers that have been in contact with patients or relatives with COVID-19.
Intervention strategies engaged by subjects are monitored to understand unmet feedings to promote well-being.
- Conditions
- Distress, Emotional, Coping Behavior
- Being tested
- well-being assessment
- Keywords
- COVID-19, resilience, depression, healthcare workers
- Medical subject headings
- COVID-19, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
well-being assessmentBehavioural
exploration of emotional, cognitive and behavioural resources of healthcare professionals
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of anxiety and depression
Hospital Anxiety and Depression Scale (HADS) Consists of 14 questions, each of which is rated from 0 to 4 according to the severity of the experienced symptoms.
Measured: 6 months
Coping strategies
Brief-COPE Consists of 28 items divided into 14 scales, relating to 14 identified coping strategies. Each item is rated on a 4 points Likert scale.
Measured: 6 months
Levels of resilience
14-Item Resilience Scale Consists of 14 items, each rated on a 7 levels Likert scale and evaluates the levels of resilience.
Measured: 6 months
Levels of fear of COVID-19
FEAR OF COVID-19 SCALE Consists of 7 items, each rated on a Likert scale from 1 to 5, with the aim of assessing the levels of fear related to COVID-19
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Sep 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies 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
- Other
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Bonassi, PhD, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890600
- Sponsor's protocol ID
- RP 20/14
- Acronym
- BE-STRONG
- Status last verified
- May 2021
- First submitted
- 22 Apr 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Psycological Well-being in Healthcare Workers of San Raffaele Institution During COVID-19 Emergency Context
- ClinicalTrials.gov ID
- NCT04890600
- Acronym / sponsor ID
- BE-STRONG / RP 20/14
- Conditions
- Distress, Emotional, Coping Behavior
- Keywords
- COVID-19, resilience, depression, healthcare workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 18 May 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.
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.
After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules.
No personal data are required.
Detailed description
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.
Data will be analysed to investigate levels of resilience in healthworkers that have been in contact with patients or relatives with COVID-19.
Intervention strategies engaged by subjects are monitored to understand unmet feedings to promote well-being.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- nurses, medical doctors, therapists, researchers, administrative workers
Key inclusion criteria (2 listed)
- Healthworkers of San Raffaele Institution
- age>18
Key exclusion criteria (1 listed)
- all those who do not agree
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 |
|---|---|---|
| well-being assessmentexploration of emotional, cognitive and behavioural resources of healthcare professionals | Behavioural | – |
Primary outcome
Levels of anxiety and depression
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS) Consists of 14 questions, each of which is rated from 0 to 4 according to the severity of the experienced symptoms.
Coping strategies
Time frame: 6 months
Brief-COPE Consists of 28 items divided into 14 scales, relating to 14 identified coping strategies. Each item is rated on a 4 points Likert scale.
Levels of resilience
Time frame: 6 months
14-Item Resilience Scale Consists of 14 items, each rated on a 7 levels Likert scale and evaluates the levels of resilience.
Levels of fear of COVID-19
Time frame: 6 months
FEAR OF COVID-19 SCALE Consists of 7 items, each rated on a Likert scale from 1 to 5, with the aim of assessing the levels of fear related to COVID-19
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 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Stefano Bonassi, PhD principal investigator
IRCCS San Raffaele Roma
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 Distress, Emotional and Coping Behavior, run by IRCCS San Raffaele Roma at 1 site 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 2 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 Apr 2024. 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 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?
Levels of anxiety and depression (time frame: 6 months). The study lists 4 primary outcomes in all. 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 10 Apr 2024.