- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368312
Psychological Impairment Due to Covid-19
May 5, 2021 updated by: University Hospital, Essen
Psychological Impairment Due to Covid-19 in Hospital Staff
Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes.
The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health.
A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters.
Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers.
We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Essen, NRW, Germany, 45147
- University Hospital Essen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Inclusion of all persons which can be attributed to hospital stuff, those include doctors and nurses (male/female)
Description
Inclusion Criteria:
Hospital staff (doctors and nurses)
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Health care providers/hospital staff
The targeted group are doctors and nurses (hospital stuff) of a large university hospital directly confronted with patients with Cov-19
|
No intervention, just of questionnaire including validated tests
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PCL5 Questionnaire
Time Frame: 14 days
|
Validated 20-items questionnaire for PTSD
|
14 days
|
|
BSI - Brief symptom inventory
Time Frame: 14 days
|
The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales.
|
14 days
|
|
PHQD
Time Frame: 14 days
|
Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment
|
14 days
|
|
WHO - QoL BREF
Time Frame: 14 days
|
Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems.
|
14 days
|
|
STAXI
Time Frame: 14 days
|
The State-Trait Anger Expression Inventory is used to measure the expressions & control of anger
|
14 days
|
|
AUDIT questionnaire
Time Frame: 14 days
|
The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
April 9, 2020
First Submitted That Met QC Criteria
April 28, 2020
First Posted (Actual)
April 29, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 5, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TEMP553914-BO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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