Survey of the Anxiety Associated With the COVID-19 Pandemic

Anxiety Related to the COVID-19 Pandemic Clinical Trial

— CORA  

Official title:

Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331106
• Other study ID #: EA1/071/20
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: April 2022

Study information

• Verified date: January 2021
• Source: Charite University, Berlin, Germany
• Contact: Antonia Bendau, M.Sc.Psych.
• Phone: +4930450517274
• Email: antonia.bendau[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to systematically examine various aspects of the anxiety associated with the COVID-19 pandemic in Germany. The data collection is carried out online with longitudinal repeated measurements.

Description:

The COVID-19 pandemic is currently one of the greatest challenges for numerous countries - also for Germany. In addition to its somatic and economic consequences, the psychological dimension of the Coronavirus pandemic is discussed increasingly and is visible in public life

• e.g. in the "pandemic-caused experience of threat", "loss of control" and "panic" of multiple people. The study examines the phenomenon of this "corona-related anxiety" in terms of epidemiological, clinical and psychosocial characteristics. It is investigated how "corona anxiety" affects people who already have an anxiety disorder or other mental illnesses as well as formerly mentally healthy people. It is also examined how media reporting and personal consequences of COVID-19 are connected with corona-related anxiety and if there is a need for therapeutic support regarding corona-related anxiety.

To answer these questions a longitudinal online survey targeting the general population in Germany is carried out. The survey takes place all three weeks as long as the pandemic lasts and ends with one follow-up one year later.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent was given

• age = 18

• able to complete the questionnaire in German

• country of residence: Germany

Exclusion Criteria:

• if at least one of the inclusion criteria is not met

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Related to the COVID-19 Pandemic

Intervention

Diagnostic Test:
• Online Questionnaire
Online Questionnaire via SoSci Survey

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of COVID-19-related anxiety	To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.	1 day
Primary	COVID-19-related anxiety symptoms	Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.	1 day
Secondary	Self-efficacy and coping with COVID-19	Self-efficacy and coping with the COVID-19 pandemic are measured with 13 self created items. Values ranging from 1 to 6; higher scores indicate a better outcome (except inverted items).	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
Secondary	Consequences of COVID-19 in the last three weeks.	Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
Secondary	General Illness Attitude	General illness attitudes are measured with 3 subscales (Worry about illness; Thanatophobia; Bodily preoccupations) of the German version of the Illness Attitude Scales (IAS) by Hiller & Rief (2004). 9 Items; values ranging from 1 to 5, higher scores indicate a worse outcome.	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
Secondary	Media reporting	Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
Secondary	Ultra-brief screening scale for anxiety and depression	To screen for general anxiety and depressive symptoms the German version of the Patient Health Questionnaire-4 (PHQ-4) by Löwe (2015) is used. 4 items; values ranging from 0 to 3, higher scores indicate a worse outcome.	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
Secondary	Change in characteristics of COVID-19-related anxiety	To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
Secondary	Change in COVID-19-related anxiety symptoms	Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.	baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months