- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631497
Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kraków, Poland, 31-501
- University Hospital in Cracow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
adult employees of the Intensive Care Unit, agreeing to undergo the tests.
Exclusion Criteria:
- patient's refusal to participate in the study
- not understanding the test questions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression
Time Frame: 1 month
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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 |
1 month
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Stress
Time Frame: 1 month
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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. |
1 month
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Deal with Stress
Time Frame: 1 month
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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.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stress 2
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tomasz Skladzien, Ph.D. M.D., Jagiellonian University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Depression
- Depressive Disorder
- COVID-19
Other Study ID Numbers
- 1072.6120.161.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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