Mental DisorderSCHIZOVID-19NCT04356885
COVID-19 and Psychotic Symptoms in France
An observational study of Mental Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Aug 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals from the general population with or without a mental disorder
Who may be able to join
- Individuals from the general population with or without a mental disorder
- French native speaker
- Majority 18 years and more
Who cannot join
- Patient refusing to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France
Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.
Read the detailed description
The pandemic of the novel coronavirus disease (COVID-19) has now affected millions of people, including people in France. There are reports in the media about increased stress, anxiety and isolation for the entire population. Likewise, there are many concerns regarding people with mental health issues including people experiencing psychotic symptoms. Thus, studies are needed to understand better the effects of the COVID-19 pandemic and related government measures (e.g., self-isolation) on the mental health and specifically on psychotic experiences. To reach this aim the investigators designed an online survey evaluating people's perceptions of the COVID-19 pandemic and government measures, their habits during the isolation period, to what extent they feel lonely, how they are managing their emotions, their general emotional state and finally the presence of psychotic experiences. Participants will be invited to complete these measures three times. Participants will complete the survey again in 1 week and then in 1 month.
The specific goals of this project are:
- Determine the association between psychotic symptoms (paranoia and hallucinations) and perception of the COVID-19 pandemic and government measures, level of activity, isolation, emotion regulation, cognitive bias and negative affect at Time 1.
- Determine which factors predict psychotic symptoms one week later and one month later.
- Explore changes across time on these measures.
Methodology:
The entire study will be conducted online. Participants will be assessed at baseline_ T1: Peak of the COVID-19 pandemic; T2: 1 week after T1; T3: 1 month after T1.
Participants will provide their informed consent. At these assessment moments, they will complete a set of self-report measures assessing COVID-19 related psychological aspects, emotion regulation, current levels of activity, cognitive bias, as well as paranoid ideation and hallucinatory experiences.
- Participants will create their own ID code (so the investigators can then match their data) and when providing their informed consent to the study they would give us their email addresses so the investigators could contact them to fill out the measures in the 2nd/3rd assessment moment
Sample size:
The investigators have not set a minimum/maximum sample size for this study. The study will remain open until the end of the self-isolation period in France. The investigators hope to recruit at least 600 participants.
List of self-report measures:
- Behavioral activation for Depression Scale
- The UCLA Loneliness Scale
- The Brief Experiential Avoidance Questionnaire
- Cognitive Emotional Regulation Questionnaire
- items measuring cognitive restructuring and catastrophisation
- Repetitive Thinking Questionnaire
- Cognitive bias questionnaire for Psychosis
- Depression Anxiety and Stress Scale
- Paranoia Scale
- Cardiff Anomalous Perceptions Scale
- Conditions
- Mental Disorder
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of the Cardiff Anomalous Perceptions Scale (CAPS)
The CAPS is a 32-item self-report scale designed to measure perceptual anomalies and hallucinatory experience that has already been validated in clinical and nonclinical populations. Each of the 32 items involves a question related to a specific hallucinatory experience to which the participant can answer 'yes' or 'no'. If the participant answers 'yes' they are asked to rate how distressing, how intrusive and how often the experience occurs on separate 1-5 rated Likert scales. The scale total is calculated as the total number items responded to with 'yes' (possible range 0-32) and the subscale totals are calculated as the total of the subscale items (possible range 0-160)
Measured: inclusion, 1 week after inclusion and 1 month after inclusion
Secondary outcomes (1)
Paranoia Scale
Paranoia Scale : this self-report scale is widely used in the assessment of paranoia in the general population.
The scale is comprised of a set of 20 items, answered in a Likert-like scale ranging from 1 (never) to 5 (always). Scores can vary between 20 and 100, where higher scores indicate greater paranoid ideation
Measured: inclusion, 1 week after inclusion and 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Epsylon Laboratory, EA 4556, University Paul Valéry Montpellier 3, France, Laboratoy LIP/PC2S, University Grenobles-Alpes, Grenoble, France, Centre référent de réhabilitation psychosociale de Grenoble, Grenoble, France
- Responsible party
- Sponsor
- Investigators
- Stéphane Raffard, PhD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356885
- Sponsor's protocol ID
- RECHMPL20_0225
- Acronym
- SCHIZOVID-19
- Status last verified
- Dec 2020
- First submitted
- 19 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France
- ClinicalTrials.gov ID
- NCT04356885
- Acronym / sponsor ID
- SCHIZOVID-19 / RECHMPL20_0225
- Conditions
- Mental Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Epsylon Laboratory, EA 4556, University Paul Valéry Montpellier 3, France, Laboratoy LIP/PC2S, University Grenobles-Alpes, Grenoble, France, Centre référent de réhabilitation psychosociale de Grenoble, Grenoble, France
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Apr 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.
Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.
Detailed description
The pandemic of the novel coronavirus disease (COVID-19) has now affected millions of people, including people in France. There are reports in the media about increased stress, anxiety and isolation for the entire population. Likewise, there are many concerns regarding people with mental health issues including people experiencing psychotic symptoms. Thus, studies are needed to understand better the effects of the COVID-19 pandemic and related government measures (e.g., self-isolation) on the mental health and specifically on psychotic experiences. To reach this aim the investigators designed an online survey evaluating people's perceptions of the COVID-19 pandemic and government measures, their habits during the isolation period, to what extent they feel lonely, how they are managing their emotions, their general emotional state and finally the presence of psychotic experiences. Participants will be invited to complete these measures three times. Participants will complete the survey again in 1 week and then in 1 month.
The specific goals of this project are:
- Determine the association between psychotic symptoms (paranoia and hallucinations) and perception of the COVID-19 pandemic and government measures, level of activity, isolation, emotion regulation, cognitive bias and negative affect at Time 1.
- Determine which factors predict psychotic symptoms one week later and one month later.
- Explore changes across time on these measures.
Methodology:
The entire study will be conducted online. Participants will be assessed at baseline_ T1: Peak of the COVID-19 pandemic; T2: 1 week after T1; T3: 1 month after T1.
Participants will provide their informed consent. At these assessment moments, they will complete a set of self-report measures assessing COVID-19 related psychological aspects, emotion regulation, current levels of activity, cognitive bias, as well as paranoid ideation and hallucinatory experiences.
- Participants will create their own ID code (so the investigators can then match their data) and when providing their informed consent to the study they would give us their email addresses so the investigators could contact them to fill out the measures in the 2nd/3rd assessment moment
Sample size:
The investigators have not set a minimum/maximum sample size for this study. The study will remain open until the end of the self-isolation period in France. The investigators hope to recruit at least 600 participants.
List of self-report measures:
- Behavioral activation for Depression Scale
- The UCLA Loneliness Scale
- The Brief Experiential Avoidance Questionnaire
- Cognitive Emotional Regulation Questionnaire
- items measuring cognitive restructuring and catastrophisation
- Repetitive Thinking Questionnaire
- Cognitive bias questionnaire for Psychosis
- Depression Anxiety and Stress Scale
- Paranoia Scale
- Cardiff Anomalous Perceptions Scale
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals from the general population with or without a mental disorder
Key inclusion criteria (3 listed)
- Individuals from the general population with or without a mental disorder
- French native speaker
- Majority 18 years and more
Key exclusion criteria (1 listed)
- Patient refusing to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total score of the Cardiff Anomalous Perceptions Scale (CAPS)
Time frame: inclusion, 1 week after inclusion and 1 month after inclusion
The CAPS is a 32-item self-report scale designed to measure perceptual anomalies and hallucinatory experience that has already been validated in clinical and nonclinical populations. Each of the 32 items involves a question related to a specific hallucinatory experience to which the participant can answer 'yes' or 'no'. If the participant answers 'yes' they are asked to rate how distressing, how intrusive and how often the experience occurs on separate 1-5 rated Likert scales. The scale total is calculated as the total number items responded to with 'yes' (possible range 0-32) and the subscale totals are calculated as the total of the subscale items (possible range 0-160)
1 secondary outcome
Paranoia Scale
Time frame: inclusion, 1 week after inclusion and 1 month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Stéphane Raffard, PhD principal investigator
University Hospitals of Montpellier
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 Mental Disorder, run by University Hospital, Montpellier at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 29 Dec 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of the Cardiff Anomalous Perceptions Scale (CAPS) (time frame: inclusion, 1 week after inclusion and 1 month after inclusion). 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 29 Dec 2020.