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Psychological Impairment Due to Covid-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368312
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Essen

Brief Summary:
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.

Condition or disease Intervention/treatment
Psychological Distress Quality of Life Other: No intervention

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Impairment Due to Covid-19 in Hospital Staff
Estimated Study Start Date : May 6, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


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
Other: No intervention
No intervention, just of questionnaire including validated tests




Primary Outcome Measures :
  1. PCL5 Questionnaire [ Time Frame: 14 days ]
    Validated 20-items questionnaire for PTSD

  2. 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.

  3. PHQD [ Time Frame: 14 days ]
    Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment

  4. 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.

  5. STAXI [ Time Frame: 14 days ]
    The State-Trait Anger Expression Inventory is used to measure the expressions & control of anger

  6. AUDIT questionnaire [ Time Frame: 14 days ]
    The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

Inclusion Criteria:

Hospital staff (doctors and nurses)

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368312


Contacts
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Contact: Johannes Siebermair, MD 0049 201 723 84345 johannes.siebermair@uk-essen.de

Sponsors and Collaborators
University Hospital, Essen
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Responsible Party: University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04368312    
Other Study ID Numbers: TEMP553914-BO
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Essen:
quality of life
psychological distress