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

July 23, 2021 updated by: Medical University of Graz

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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 %.

Description

Inclusion Criteria:

  • Minimum age 18 years
  • voluntary participation

Exclusion Criteria:

  • Subject refuses to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
1 year
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)
1 year
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)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Life style changes
Time Frame: 1 year
Lifestyle Questions including physical activity, eating behavior, substance use, smoking
1 year
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)
1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva Reininghaus, Prof., Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 32-363 ex 19/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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