NCT04374097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,778

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

7 days

First QC Date

May 2, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

COVID-19Health personnelPredictorPTSDAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist for DSM-5 (PCL-5)

    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.

    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

Secondary Outcomes (3)

  • Patient Health Questionnaire 9 (PHQ-9)

    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)

    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]

  • Health anxiety

    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

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Biological Sex and self-representation of gender are measured. All participants are welcome to partake in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepressionCOVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professer Sverre Urnes Johnson

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 5, 2020

Study Start

March 31, 2020

Primary Completion

April 7, 2020

Study Completion

April 7, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations