Psychological Impact of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders
Psychological Impact and Effect of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders - an Online Survey
1 other identifier
observational
1,000
1 country
1
Brief Summary
The aim of this study is to measure current affective symptoms and psychological distress in individuals with severe mental illness during the COVID-19 pandemic using an online questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep quality, attitudes concerning the virus, the adherence to the measures, believing processes, and coping strategies/resilience patterns referring to COVID-19 in different study centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
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
Study Start
First participant enrolled
April 28, 2020
CompletedFirst Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJuly 26, 2021
July 1, 2021
2 years
May 14, 2020
July 23, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index)
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)
1 year
Depressive symptoms
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)
1 year
Sleep disorders and Sleep Quality
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)
1 year
Secondary Outcomes (3)
Life style changes
1 year
Food Craving
1 year
COVID-19 associated fears and emotional responses to the pandemic
1 year
Study Arms (2)
Psychiatric patients
Psychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis
Healthy Controls
Participants who do not have a psychiatric disorder or a first degree relative with psychiatric disorder.
Interventions
Eligibility Criteria
Based on previous experience of the researchers working within the sector, we anticipated that it would be possible to recruit a conservative average of 100 psychiatric patients per outpatient clinic Thus, we aim to recruit at least 500 patients and 500 healthy controls in total which would be a large enough sample to conduct most subgroup analyses. Nevertheless, in case we can recruit a larger number of participants allowing further subgroup analysis it would be useful. The assumed response rate is 70 %.
You may qualify if:
- Minimum age 18 years
- voluntary participation
You may not qualify if:
- Subject refuses to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine
Graz, Styria, 8036, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Reininghaus, Prof.
Medical University of Graz
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
June 1, 2020
Study Start
April 28, 2020
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
July 26, 2021
Record last verified: 2021-07