CORA: Survey of the Anxiety Associated With the COVID-19 Pandemic

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT04331106
Collaborator
(none)
7,500
1
24.1
310.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Online Questionnaire

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
7500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany
Actual Study Start Date :
Mar 27, 2020
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Population in Germany

Reasonably large and representative sample of the general population in Germany

Diagnostic Test: Online Questionnaire
Online Questionnaire via SoSci Survey

Outcome Measures

Primary Outcome Measures

  1. Characteristics of COVID-19-related anxiety [1 day]

    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.

  2. COVID-19-related anxiety symptoms [1 day]

    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.

Secondary Outcome Measures

  1. Self-efficacy and coping with 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]

    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).

  2. Consequences of COVID-19 in the last three weeks. [baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months]

    Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.

  3. General Illness Attitude [baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months]

    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.

  4. Media reporting [baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months]

    Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.

  5. Ultra-brief screening scale for anxiety and depression [baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months]

    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.

  6. Change in characteristics of COVID-19-related anxiety [baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months]

    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.

  7. Change in COVID-19-related anxiety symptoms [baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy Berlin Germany 10117

Sponsors and Collaborators

  • Charite University, Berlin, Germany

Investigators

  • Study Director: Andreas Ströhle, Prof.Dr., Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
  • Principal Investigator: Antonia Bendau, M.Sc.Psych., Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonia Bendau, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT04331106
Other Study ID Numbers:
  • EA1/071/20
First Posted:
Apr 2, 2020
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antonia Bendau, Principal Investigator, Charite University, Berlin, Germany
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2021