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PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up

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: NCT04442243
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Modum Bad Psychiatric Center
Information provided by (Responsible Party):
Sverre Urnes Johnson, University of Oslo

Brief Summary:
The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.

Condition or disease
Post Traumatic Stress Disorder Anxiety Depression

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Study Type : Observational
Estimated Enrollment : 889 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up
Estimated Study Start Date : June 22, 2020
Estimated Primary Completion Date : July 13, 2020
Estimated Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire ]
    PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.


Secondary Outcome Measures :
  1. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire ]
    The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.

  2. Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire ]
    The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.

  3. The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [ Time Frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire ]
    WEMWBS short version consist of 7 items



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Vulnerable health-care or public service providers was in this sample defined as doctors, nurses, psychologists, and any other health-care workers, as well as politicians and social workers. The participants reported if they worked directly or indirectly with COVID-19 patients.
Criteria

Inclusion Criteria:

  • Health care or public service providers above 18

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): NCT04442243


Contacts
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Contact: Sverre Urnes Johnson, PhD +47 41633313 sverreuj@psykologi.uio.no
Contact: Omid Ebrahimi omideb@uio.no

Sponsors and Collaborators
University of Oslo
Modum Bad Psychiatric Center
Investigators
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Principal Investigator: Omid Ebrahimi, Mr University of Oslo & Modum Bad
Principal Investigator: Asle Hoffart, PhD University of Oslo & Modum Bad
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Responsible Party: Sverre Urnes Johnson, Associate Professer Sverre Urnes Johnson, University of Oslo
ClinicalTrials.gov Identifier: NCT04442243    
Other Study ID Numbers: REK125510 (4)
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 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
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders