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Corona Virus InfectionNCT04410835

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

An observational study of Corona Virus Infection and Psychiatric Disorder, run by Medical University of Graz at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Online Survey
How many people
1,000 participants
Where
1 siteAustria
Study dates
28 Apr 2020to 30 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 %.

Who may be able to join

  • Minimum age 18 years
  • voluntary participation

Who cannot join

  • Subject refuses to participate

Trial locations and contacts

1 site in 1 country.

Eva Reininghaus, Prof. contact

004331638580968

eva.reininghaus@medunigraz.at

Nina Dalkner, PD Dr. contact

004331638530081

nina.dalkner@medunigraz.at

Austria1 site, 1 recruiting
  • Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine

    Graz, Styria, 8036

    Eva Reininghaus, Asszo.Prof., +43316-385-80968, eva.reininghaus@medunigraz.at

    Nina Dalkner, PD Dr., +43316-385-30081 ext. 06603497536, nina.dalkner@medunigraz.at

    Recruiting

Other trials in Austria

About this study

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

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.

Read the 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.
Being tested
Online Survey
Medical subject headings
Coronavirus Infections, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online SurveyDiagnostic test

    Psychological questionnaires

Study groups in NCT04410835
Study groupRoleWhat they receive
Psychiatric patientsPsychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis
Receives: Diagnostic Test: Online Survey
Healthy ControlsParticipants who do not have a psychiatric disorder or a first degree relative with psychiatric disorder.
Receives: Diagnostic Test: Online Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 year

  2. 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)

    Measured: 1 year

  3. 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)

    Measured: 1 year

Secondary outcomes (3)
  1. Life style changes

    Lifestyle Questions including physical activity, eating behavior, substance use, smoking

    Measured: 1 year

  2. Food Craving

    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)

    Measured: 1 year

  3. COVID-19 associated fears and emotional responses to the pandemic

    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)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start28 Apr 2020
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410835
Sponsor's protocol ID
32-363 ex 19/20
Status last verified
Jul 2021
First submitted
14 May 2020
Last updated
26 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Corona Virus Infection and Psychiatric Disorder, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eva Reininghaus, Prof. (004331638580968, eva.reininghaus@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.

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