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.
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
- Conditions the study is for
- Corona Virus Infection, Psychiatric Disorder, Psychological Distress
- 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.
Austria1 site, 1 recruiting
- 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
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
- 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?
- 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?
- 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?
- 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?
- Are there sex and age differences in the investigated variables? (emotional response to COVID-19 outbreak, attitude towards measures, adherence)?
- 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 group | Role | What they receive |
|---|---|---|
| Psychiatric patients | Psychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis Receives: Diagnostic Test: Online Survey | |
| Healthy Controls | Participants 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.
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
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
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)
Life style changes
Lifestyle Questions including physical activity, eating behavior, substance use, smoking
Measured: 1 year
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
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.
- First posted1 Jun 2020
- Study start28 Apr 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Reininghaus, Prof., Principal investigator, Medical University of Graz
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04410835
- Acronym / sponsor ID
- 32-363 ex 19/20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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?
- 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?
- 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?
- 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?
- Are there sex and age differences in the investigated variables? (emotional response to COVID-19 outbreak, attitude towards measures, adherence)?
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychiatric patients | – | Diagnostic Test: Online SurveyPsychiatric patients with ICD-10 (International Statistical Classification of Diseases and Related Health Problems) F2/F3/F4 diagnosis |
| Healthy Controls | – | Diagnostic Test: Online SurveyParticipants who do not have a psychiatric disorder or a first degree relative with psychiatric disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 %.
Key inclusion criteria (2 listed)
- Minimum age 18 years
- voluntary participation
Key exclusion criteria (1 listed)
- Subject refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online SurveyPsychological questionnaires | Diagnostic test | Healthy Controls, Psychiatric patients |
Primary outcome
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)
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)
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)
3 secondary outcomes
Life style changes
Time frame: 1 year
Food Craving
Time frame: 1 year
COVID-19 associated fears and emotional responses to the pandemic
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Reininghaus, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
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.