Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychological Impact of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410835
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease Intervention/treatment
Corona Virus Infection Psychiatric Disorder Psychological Distress Diagnostic Test: Online Survey

Show Show detailed description

Layout table for study information
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 : December 31, 2020
Estimated Study Completion Date : April 28, 2021


Group/Cohort Intervention/treatment
Psychiatric patients
Psychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis
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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. Life style changes [ Time Frame: 1 year ]
    Lifestyle Questions including physical activity, eating behavior, substance use, smoking

  2. 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)

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
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 %.
Criteria

Inclusion Criteria:

  • Minimum age 18 years
  • voluntary participation

Exclusion Criteria:

  • Subject refuses to participate

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Eva Reininghaus, Prof. 004331638580968 eva.reininghaus@medunigraz.at
Contact: Nina Dalkner, PD Dr. 004331638530081 nina.dalkner@medunigraz.at

Locations
Layout table for location information
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   
Sponsors and Collaborators
Medical University of Graz
Investigators
Layout table for investigator information
Principal Investigator: Eva Reininghaus, Prof. Medical University of Graz
Layout table for additonal information
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: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Mental Disorders
Problem Behavior
Virus Diseases
Behavioral Symptoms
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases