NCT04442243

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
889

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 19, 2020

Last Update Submit

June 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist for DSM-5 (PCL-5)

    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.

    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

Secondary Outcomes (3)

  • Patient Health Questionnaire 9 (PHQ-9)

    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

  • Generalized Anxiety Disorder 7 (GAD-7)

    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 Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Health care or public service providers above 18

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Omid Ebrahimi, Mr

    University of Oslo & Modum Bad

    PRINCIPAL INVESTIGATOR
  • Asle Hoffart, PhD

    University of Oslo & Modum Bad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Urnes Johnson, PhD

CONTACT

Omid Ebrahimi

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

June 22, 2020

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share