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

• ClinicalTrials.gov Identifier: NCT04410835
• Recruitment Status: Recruiting
• First Posted: June 1, 2020
• Last Update Posted: July 26, 2021
• Sponsor: Medical University of Graz
• Information provided by (Responsible Party): Medical University of Graz

Study Description

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

Detailed Description:

A novel corona virus (SARS-CoV-2) has been identified as the cause of an outbreak of respiratory illness (corona virus disease COVID-19) all over the world. The COVID-19 pandemic is a public health emergency of international concern and poses a challenge to psychological resilience.

Studies reviewed the psychological impact of quarantine and reported negative psychological effects including post-traumatic stress symptoms, confusion, and anger, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. A loss of daily structure and reduced social contacts were associated with frustration, boredom, reduced psychological-well being and psychological distress.

A recently conducted online questionnaire survey, investigating emotional responses and coping strategies of nurses, found sex differences in anxiety and fear referred to COVID-19 (women showed more severe anxiety and fear than men) and differences between participants from cities showing more anxiety and fear compared with participants from rural showing more sadness. The closer COVID-19 was to the participants, the stronger the anxiety and anger.

All these investigated psychological variables (i.e. anxiety, depression, boredom, loss of daily structure) have been found to impact the course and outcome of psychiatric disorders. Nowadays, COVID-19 is a pressure source with great influence, both for individuals and for the social public groups. Different individuals and groups may experience different levels of psychological crisis and patients with psychiatric disorders may experience more or less psychological symptoms than healthy control persons. According to a recent study, lithium, widely used to treat bipolar disorder, has been shown to exhibit antiviral activity and appears as a possible candidate for therapy of COVID-19. However, more research data are needed to develop evidence-driven strategies to reduce adverse psychological impacts and psychiatric symptoms during the pandemic.

Scientific questions

1. How do psychiatric patients experience the COVID-19 outbreak including quarantine and are there associations with affective symptoms and psychological distress? Is there a change in symptomatology during time? Are there differences to healthy controls, and between individuals with different diagnosis?
2. Is there a difference between psychiatric patients and healthy controls in regard to emotional response, cognition and behaviour during the COVID-19 pandemic and quarantine? Is there a difference between different psychiatric diagnosis groups?
3. Is there an association between consequences of social distance on lifestyle factors (nutrition, sleep quality, physical activity, substance abuse) and are there associations with psychological well-being/psychological symptoms in individuals with psychiatric disorder and controls? Is there a difference between different psychiatric diagnosis groups and healthy controls?
4. What do individuals with psychiatric disorders think about the COVID-19 related measures und quarantine regulations and how is the adherence to the measures? Are there associations between adherence and attitude towards COVID-19 measures? Is there a difference between patients and healthy controls? Is there a difference between different psychiatric diagnosis groups?
5. Are there sex and age differences in the investigated variables? (emotional response to COVID-19 outbreak, attitude towards measures, adherence)?
6. Is there a relationship between an infection with SARS-CoV-2 and disease course in psychiatric disorder? Is there a difference between different psychiatric diagnosis groups and healthy controls? Which role plays lithium treatment (prescribed beyond the study) in this context? The investigators hypothesize, loss of daily structure, reduced social contacts, loneliness, reduced psychiatric care, and other possible lifestyle changes due to the quarantine and social distancing measures, have a negative effect on psychological symptoms (depression, anxiety, somatisation, sleep quality) in individuals with psychiatric disorder compared to healthy controls. In contrast, resilience and positive cognition processes might be positively correlated to psychological well-being.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Eva Reininghaus, Prof.; 004331638580968; eva.reininghaus@medunigraz.at

Contact: Nina Dalkner, PD Dr.; 004331638530081; nina.dalkner@medunigraz.at

Locations

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

• Principal Investigator: Eva Reininghaus, Prof.; Medical University of Graz

More 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
• 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

Additional relevant MeSH terms:

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