Psychological Impact of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders
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ClinicalTrials.gov Identifier: NCT04410835 |
Recruitment Status :
Recruiting
First Posted : June 1, 2020
Last Update Posted : July 26, 2021
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Condition or disease | Intervention/treatment |
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Corona Virus Infection Psychiatric Disorder Psychological Distress | Diagnostic Test: Online Survey |

Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Psychological Impact and Effect of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders - an Online Survey |
Actual Study Start Date : | April 28, 2020 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | April 30, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Psychiatric patients
Psychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis
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Diagnostic Test: Online Survey
Psychological questionnaires |
Healthy Controls
Participants who do not have a psychiatric disorder or a first degree relative with psychiatric disorder.
|
Diagnostic Test: Online Survey
Psychological questionnaires |
- Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index) [ Time Frame: 1 year ]Brief Symptom Inventory-18 with higher scores meaning a worse outcome (more depression, anxiety and somatization); Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 72)
- Depressive symptoms [ Time Frame: 1 year ]Beck Depression Inventory-II with higher scores mean a worse Outcome (more depressive Symptoms; each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
- Sleep disorders and Sleep Quality [ Time Frame: 1 year ]Pittsburgh Sleep Quality Index (PSQI) with higher scores mean a worse Outcome (more sleeping disturbances; Each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
- Life style changes [ Time Frame: 1 year ]Lifestyle Questions including physical activity, eating behavior, substance use, smoking
- Food Craving [ Time Frame: 1 year ]Food Craving Inventory (FCI) with higher scores mean a worse Outcome (more Food craving; Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 112)
- COVID-19 associated fears and emotional responses to the pandemic [ Time Frame: 1 year ]COVID-19 questionnaire with higher scores meaning a worse Outcome (more fears and negative emotions; each item is weighted on a 0-10 interval scale)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Minimum age 18 years
- voluntary participation
Exclusion Criteria:
- Subject refuses to participate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410835
Contact: Eva Reininghaus, Prof. | 004331638580968 | eva.reininghaus@medunigraz.at | |
Contact: Nina Dalkner, PD Dr. | 004331638530081 | nina.dalkner@medunigraz.at |
Austria | |
Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine | Recruiting |
Graz, Styria, Austria, 8036 | |
Contact: Eva Reininghaus, Asszo.Prof. +43316-385-80968 eva.reininghaus@medunigraz.at | |
Contact: Nina Dalkner, PD Dr. +43316-385-30081 ext 06603497536 nina.dalkner@medunigraz.at |
Principal Investigator: | Eva Reininghaus, Prof. | Medical University of Graz |
Responsible Party: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT04410835 |
Other Study ID Numbers: |
32-363 ex 19/20 |
First Posted: | June 1, 2020 Key Record Dates |
Last Update Posted: | July 26, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Coronavirus Infections Mental Disorders Problem Behavior Virus Diseases Infections Respiratory Tract Infections Pneumonia, Viral |
Pneumonia Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Behavioral Symptoms |