Condition category
Not Applicable
Date applied
01/04/2020
Date assigned
01/04/2020
Last edited
04/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Despite containment measures, the virus spread exponentially. On March 11, 2020, the World Health Organization announced a pandemic. In Europe, the first clusters appeared on the 22nd of February 2020 in Northern Italy and soon the health system in Northern Italy could not cope with the massive amount of new patients with respiratory failure needing invasive ventilation support. The long-working hours, need for “hard triage” for ventilation support and the strong restrictions in daily life implemented by the government had serious effects on healthcare workers and the general population.

Front-line healthcare workers directly involved in the diagnosis, treatment and care of COVID-19 patients are despite getting infected and are under particular risk of developing psychological distress and other mental health symptoms. A recent study from China showed a high prevalence of mental health symptoms among healthcare professionals, including depression, insomnia, anxiety or trauma stress disorder (Lai et al., 2020), similar to those found in military personnel after having been at war. Feelings of vulnerability to disease, concerns about spread of the virus to family members or friends, need for self-isolation and changes in the work sense of coherence are purported to play a role in the development of such symptoms. These negative stress outcomes can impact not only on the wellbeing of health professionals, but also on their ability to care effectively for others (Barnett, et al., 2007). Additionally, they affect all healthcare workers, irrespective of culture. On the other hand, individuals with a strong sense of coherence are less prone to burn-out and are mentally healthier. Moreover, adopting resilience-enhancing strategies may improve day-to-day performance at work and at home.

This study investigates the relationship between work sense of coherence and individual resilience on healthcare professionals' mental health during this COVID-19 pandemic. No other study addresses this gap in knowledge.
1. Is there a relationship between individual resilience and work sense of coherence and the development of anxiety, depression and traumatic stress disorder in frontline health care personnel during the pandemic outbreak?
2. Does contamination anxiety and COVID-19 anxiety differ over time, across countries in frontline health care personnel?
3. How does resilience and work sense of coherence influence the development of anxiety, depression and traumatic stress disorder in these health care workers during the pandemic outbreak?

Who can participate?
Healthcare professionals, >18 years of age, willing to participate.

What does the study involve?
Healthcare professionals will be asked to fill in a number of online questionnaires at three timepoints during a six-month period.

What are the possible benefits and risks of participating?
None anticipated.

Where is the study run from?
Department of Anaesthesia and Pain Medicine, Inselspital, Bern University Hospital, Bern (Switzerland). Data will be collected from hospitals in Europe, USA, and New Zealand.

When is the study starting and how long is it expected to run for?
April 2020 to January 2021

Who is funding the study?
Department of Anaesthesia and Pain Medicine, Inselspital, Bern University Hospital, Bern (Switzerland)

Who is the main contact?
Dr Alexander Fuchs, alexander.fuchs@insel.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexander Fuchs

ORCID ID

http://orcid.org/0000-0001-7188-1683

Contact details

Department of Anaesthesia and Pain Medicine
Inselspital
Bern University Hospital
Freiburgstrasse 8-10
Bern
3010
Switzerland
+41 31 632 88 35
alexander.fuchs@insel.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DARVID1

Study information

Scientific title

Distress And Resilience of healthcare professionals during the COVID-19 pandemic

Acronym

DARVID

Study hypothesis

1. COVID-19 anxiety and contamination anxiety do not remain stable over time, across countries, and relate to the proximity with infected patients.
2. There is a relationship between individual resilience and work sense of coherence and the development of mental symptoms in front liners during pandemic outbreaks

Ethics approval

Approved 01/04/2020, Gesundheits- und Fürsorgedirektion des Kantons Bern, Kantonale Ethikkomission für die Forschung Bern (Ethics Committee of the Canton of Bern, Murtenstrasse 31, 3010 Bern, Switzerland; +41 31 633 7070; info.kek.kapa@gef.be.ch), ref: Req-2020-00355

Study design

Mixed-methods observational

Primary study design

Observational

Secondary study design

Qualitative research

Trial setting

Internet

Trial type

Other

Patient information sheet

https://psyunibe.qualtrics.com/jfe/form/SV_3WYgbkLWqiDPDG5

Condition

Individual resilience and work sense of coherence and the development of mental symptoms during a pandemic scenario

Intervention

Matched longitudinal internet-based survey with pre-existing, validated self-questionnaires (Work-SoC, PHQ-9, IES-6, PVD, SFI, CD-RISC 10), at 3 time periods of 2 weeks over 6 months, with the option to prolong depending on the development of the pandemic.

Semi-structured interviews with focus groups after the last period of the survey.

Intervention type

Other

Phase

Drug names

Primary outcome measure

COVID-19 Anxiety (adapted SARS-Anxiety-Scale) at 3 time periods of 2 weeks over 6 months

Secondary outcome measures

At 3 time periods of 2 weeks over 6 months:
1. Contamination anxiety (PVS)
2. Anxiety to get infected at work measured with a single generated Item («I am afraid I will become infected with COVID-19 while on the job») on a visual analog scale from «0 = Not at all» to «10 = Extremely»
3. Depression (PHQ-9)
4. Traumatic Stress (IES-6)
5. Work Coherence (Work-SoC)

Qualitative measures:
6. Influence of resilience and work sense of coherence on the development of anxiety, depression and trauma stress disorder in frontliners during pandemic outbreak measured using structured interview.

Overall trial start date

15/03/2020

Overall trial end date

01/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthcare professionals
2. >18 years of age
3. Willing to participate

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

02/04/2020

Recruitment end date

16/04/2020

Locations

Countries of recruitment

Australia, Austria, Belgium, Brazil, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Southern Territories, Germany, Greece, Ireland, Isle of Man, Israel, Italy, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States of America

Trial participating centre

Bern University Hospital
Department of Anaesthesiology and Pain Therapy Inselspital Freiburgstrasse 8-10
Bern
3010
Switzerland

Sponsor information

Organisation

University Hospital of Bern

Sponsor details

Department of Anaesthesia and Pain Medicine
Inelspital
Freiburgstrasse 8-10
Bern
3010
Switzerland
+41 31 632 88 35
robert.greif@insel.ch

Sponsor type

Hospital/treatment centre

Website

http://www.anaesthesiologie.insel.ch

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Bern

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication of results in the dedicated journals - first trimester 2021.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Dr. Phil. Sandra Abegglen (sandra.abegglen@psy.unibe.ch). Both qualitative and quantitative data are expected to be available as from March 2021, for a period of 10 years. Data originating from questionnaires will be stored in a secure online site accessible to the investigators only. All researchers will comply with the Data Protection Act and the Swiss Law for Human Research. All data will be destroyed 10 years after the end of the project.

Intention to publish date

31/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32737101/ (added 04/08/2020)

Publication citations

Additional files

Editorial Notes

04/08/2020: Publication reference added. 27/07/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 16/10/2020 to 16/04/2020. 2. The ethics approval was added. 03/04/2020: The trial contact name has been corrected. 01/04/2020: Trial’s existence confirmed by Swiss Ethics.