DepressionNCT04631497
Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
An observational study of Depression, run by Jagiellonian University at 1 site in Poland.
Trial summary
Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- test
- How many people
- 46 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2020to 31 Dec 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: University Hospital in Cracow ICU depratment
Who may be able to join
- adult employees of the Intensive Care Unit, agreeing to undergo the tests.
Who cannot join
- patient's refusal to participate in the study
- not understanding the test questions
Trial locations and contacts
1 site in 1 country.
About this study
Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.
Read the detailed description
Every day medical staff working in very difficult conditions of intensive care. The COVID-19 virus outbreak has set another difficult task for doctors and nurses who have previously had a lot of contact with the death of their patients. The appearance of the COVID-19 virus and, above all, the inability to effectively treat the infection causes an additional psychological stimulus in medical personnel.
The aim of the study is to assess the occurrence of psychiatric disorders in medical personnel dealing with patients suffering from COVID-19 using various psychological tests.
- Conditions
- Depression
- Being tested
- test
- Keywords
- Healthcare Workers, COVID-19, Mental Health Outcomes
- Medical subject headings
- Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testDiagnostic test
- Beck's Test
- Test STAI
- Test PSS
- the scale of the fascination with death
- COPE
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | The study will cover employees of the Intensive Care Unit - nurses and doctors working with patients with COVID-19 infection. Test takers will be over the age of 18 and under the age of 70, female and male. Receives: Diagnostic Test: test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Beck's test the BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Measured: 1 month
Stress
Perceived Stress Scale (PSS)
The PSS predicts both objective biological markers of stress and increased risk for disease among persons with higher perceived stress levels. For example, those with higher scores (suggestive of chronic stress) on the PSS fend worse on biological markers of aging, cortisol levels, immune markers, depression, infectious disease,wound healing, and prostate-specific antigen levels in men. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positivelystated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made fromquestions 2, 4, 5 and 10 of the PSS 10 item scale.
Measured: 1 month
Deal with Stress
COPE test It is a self-written tool consisting of 60 statements, to which the respondent responds on a 4-point scale. It allows the assessment of 15 strategies for responding to stressful situations.
Measured: 1 month
Secondary outcomes (1)
Stress 2
the scale of the fascination with death The Death Obsession Scale (DOS) was made by Abdel-Khalek. It was intended to be a main component in the death distress const.ruct: death anxiety, death depression, and death obsession. The DOS assesses a multidimensional trait. It is responded to on a five-point Likert-type rating scale as follows: No (1), A little (2), A fair amount (3), Much (4) and Very much (5). The total score can range from 15 to 75.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
- Investigators
- Tomasz Skladzien, Ph.D. M.D., Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631497
- Sponsor's protocol ID
- 1072.6120.161.2020
- Status last verified
- Jun 2022
- First submitted
- 9 Nov 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04631497
- Acronym / sponsor ID
- 1072.6120.161.2020
- Conditions
- Depression
- Keywords
- Healthcare Workers, COVID-19, Mental Health Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Nov 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.
Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.
Detailed description
Every day medical staff working in very difficult conditions of intensive care. The COVID-19 virus outbreak has set another difficult task for doctors and nurses who have previously had a lot of contact with the death of their patients. The appearance of the COVID-19 virus and, above all, the inability to effectively treat the infection causes an additional psychological stimulus in medical personnel.
The aim of the study is to assess the occurrence of psychiatric disorders in medical personnel dealing with patients suffering from COVID-19 using various psychological tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Diagnostic Test: testThe study will cover employees of the Intensive Care Unit - nurses and doctors working with patients with COVID-19 infection. Test takers will be over the age of 18 and under the age of 70, female and male. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University Hospital in Cracow ICU depratment
Key inclusion criteria (1 listed)
- adult employees of the Intensive Care Unit, agreeing to undergo the tests.
Key exclusion criteria (2 listed)
- patient's refusal to participate in the study
- not understanding the test questions
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 |
|---|---|---|
| test1. Beck's Test 2. Test STAI 3. Test PSS 4. the scale of the fascination with death 5. COPE | Diagnostic test | Healthcare workers |
Primary outcome
Depression
Time frame: 1 month
Beck's test the BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Stress
Time frame: 1 month
Perceived Stress Scale (PSS) The PSS predicts both objective biological markers of stress and increased risk for disease among persons with higher perceived stress levels. For example, those with higher scores (suggestive of chronic stress) on the PSS fend worse on biological markers of aging, cortisol levels, immune markers, depression, infectious disease,wound healing, and prostate-specific antigen levels in men. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positivelystated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made fromquestions 2, 4, 5 and 10 of the PSS 10 item scale.
Deal with Stress
Time frame: 1 month
COPE test It is a self-written tool consisting of 60 statements, to which the respondent responds on a 4-point scale. It allows the assessment of 15 strategies for responding to stressful situations.
1 secondary outcome
Stress 2
Time frame: 1 month
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 6 Jun 2022.
- 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.
Tomasz Skladzien, Ph.D. M.D. principal investigator
Jagiellonian University
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 Depression, run by Jagiellonian University at 1 site in Poland.
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 2 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 6 Jun 2022. 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 Poland. 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?
Depression (time frame: 1 month). The study lists 3 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 6 Jun 2022.