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Level and Predictors of Trauma-symptoms Among Health Workers and Public Service Providers During the COVID-19 Outbreak

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ClinicalTrials.gov Identifier: NCT04374097
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 6, 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 during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also aims to investigate predictors of trauma-symptoms.

Condition or disease
Post Traumatic Stress Disorder Anxiety Depression

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Study Type : Observational
Actual Enrollment : 1778 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Level and Predictors of Trauma-symptoms Among Health Workers and Public Service Providers During the COVID-19 Outbreak
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : April 7, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway ]
    PCL-5 is 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: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway ]
    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. The Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway] ]
    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. Health anxiety [ Time Frame: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway ]
    Symptoms of health anxiety was measured with two items from the validated Health Anxiety Inventory (HAI), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus. All items used a Likert scale from 0-3, and the new total score of health anxiety had a range from 0-12.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both Biological Sex and self-representation of gender are measured. All participants are welcome to partake in the study.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Eligible participants are health-care or public service provides above 18 in Norway.

To hold the NPI variable constant, the stopping rule of data collection was at once if the NPIs were modified; new NPI were added; NPIs were removed; or novel information about modification of NPIs were given.

Criteria

Inclusion Criteria:

- All health-care or public service provides above 18 was eligible for inclusion in this study. 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.

Given the time-sensitivity of the project and the strict and time-consuming process of getting approval to access registry data, the investigators did not apply for access to registry data (e.g., address, phone or e-mails of the general population), as such data access is highly strict and regulated in Norway and the time-frame of such an application could have encompassed variation in an important variable the investigators wished to hold constant (namely identifical NPIs (non-pharmacological interventions) employed over the time-frame of data collection). Thus, the investigators did not apply for registry data, but still attempted to obtain a probability sample through the means elaborated below.

Health personnel and public service providers where systematically targeted through various channels: e.g., primarily through systematically reaching out to all hospitals in Norway and inviting health personell to participants, through contacting the Associations of all major health-worker groups (i.e., Norwegian Medical Doctors Association; Norwegian Nurses Association, Norwegian Psychologists Association; and other associations related to health-workers) through national TV, national, regional and local radio stations, and national, regional and local newspapers in the different regions of the country, as well as Facebook groups in the different regions of the country. Additionally, a random selection of those qualifying as health-care workers were randomly targeted on Facebook by a Facebook Business algorithm. Public service providers were recruited trough Facebook. Politicians where also systematically contacted, with all political parties being contacted and subsequently sending an e-mail with the survey to their members.

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): NCT04374097


Locations
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Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Modum Bad Psychiatric Center
Investigators
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Principal Investigator: Sverre Urnes Johnson, PhD University of Oslo & Modum Bad
Principal Investigator: Omid Ebrahimi University of Oslo & Modum Bad
Principal Investigator: Asle Hoffart, PhD Modum Bad & University of Oslo
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Responsible Party: Sverre Urnes Johnson, Associate Professer Sverre Urnes Johnson, University of Oslo
ClinicalTrials.gov Identifier: NCT04374097    
Other Study ID Numbers: REK125510(2)
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 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 Sverre Urnes Johnson, University of Oslo:
COVID-19
Health personnel
Predictor
PTSD
Anxiety
Depression
Additional relevant MeSH terms:
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Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders