Mental DisorderDeathPercepNCT04384419
Death Number Perception in Depression, Anxiety, and Schizoypal Personnality in General Population (Covid-19 Pandemic)
An observational study of Mental Disorder and General Population, run by University Hospital, Montpellier at 1 site in France.
Trial summary
France has been put on a lockdown for 8 weeks to prevent the spread of the COVID-19 virus between 17/03/2020 and 11/05/2020. During this lockdown, which is likely to have psychopathological repercussions on the population, the public authorities and the media informed the population about the number of deaths… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, General Population
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2020to 1 Jun 2021
- 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: General population with self reported depression, anxiety and schizotypal personnality and without mental health conditions
Who may be able to join
- Individuals from the general population
- French native speacker
- 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: Real or Concieved Death Number Perception in Depression, Anxiety and in Schizotypal Personality Disorder Following Covid-19 Pandemic Lockdown
France has been put on a lockdown for 8 weeks to prevent the spread of the COVID-19 virus between 17/03/2020 and 11/05/2020. During this lockdown, which is likely to have psychopathological repercussions on the population, the public authorities and the media informed the population about the number of deaths occurring each day. While the functioning of autobiographical memory following traumatic events remains a debate in the literature, the impact of the daily announcement of mass deaths on the memory system in the general population and the relationship between long-term memory and delusional thinking in certain psychopathologies have yet to be explored in the literature.
The investigators wish to demonstrate that self-reported recall of recorded deaths may represent this distortion of perception, symptomatic of these pathologies by an on-line questionnaire.
Read the detailed description
Indeed, it has been reported that under continued stress, delusions and psychotic experiences can occur in the general population. This phenomenon is found in individuals suffering from depression and anxiety and schizotypal personality disorder.
The investigators wish to demonstrate that self-reported recall of recorded deaths may represent this distortion of perception, symptomatic of these pathologies.
Thus, using an online longitudinal questionnaire, the investigators wish to explore :
- how the memory system is impacted by mass deaths over several trimesters in the general population.
- whether the long-term memory of people suffering from depression and anxiety disorders and people suffering from schizotypal personality disorder contains recollection of a distorted pattern in relation to the actual number of deaths.
Primary goals of this project are:
Determine, in the context of mass deaths, the level and proportion of real or conceived recall of the number of deaths in the general population based on cognitive and affective empathy profiles over four trimesters.
Also the investigators want to determine
- the proportion of real or conceived recall numbers of deaths by COVID-19 among people suffering from depression and anxiety in a context of mass death.
- the proportion of real or conceived recall number of deaths by COVID-19 among people with schizotypal personality disorder.
- the dynamics of this real or conceived recall for four trimester following the end of lockdown.
Methodology:
The entire study will be conducted online. Participants will provide their informed consent. At these assessment, they will provide a set of self report measures associated to COVID-19 related psychological aspects especially for depression, anxiety and schizotypal personality.
Subjects can only participate once.
Sample size:
There is no minimum/maximum sample size for this study. The study will remain open for 1 year. The sample size should reach 1000 participants at least.
List of self-report measures:
- Brief Trauma Questionnaire (BTQ)
- COVID-Related Thoughts and Behavioral Symptoms (COV-TaBS)
- Beck Depression Inventory (BDI)
- State and Trait Anxiety Inventory (STAI)
- The Hospital Anxiety and Depression Scale (HAPS)
- Questionnaire of Cognitive and Affective Empathy (QCAE)
- Raine Schizotypal Personality Questionnaire, (SPQ)
- Paranoia Scale
- Conditions
- Mental Disorder, General Population
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
number of perception distortions
number of perception distortions
Measured: 1 day
Secondary outcomes (1)
Recall number of deaths
Recall number of deaths
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start29 May 2020
- Primary completion30 May 2021
- Study completion1 Jun 2021
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University of Montpellier 3 (Pr. Stéphane Raffard, PhD), University of Reims Champagne-Ardenne (Ali Oker PhD)
- Responsible party
- Sponsor
- Investigators
- Stéphane Raffard, PhD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384419
- Sponsor's protocol ID
- RECHMPL20_0276
- Acronym
- DeathPercep
- Status last verified
- Jan 2022
- First submitted
- 5 May 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real or Concieved Death Number Perception in Depression, Anxiety and in Schizotypal Personality Disorder Following Covid-19 Pandemic Lockdown
- ClinicalTrials.gov ID
- NCT04384419
- Acronym / sponsor ID
- DeathPercep / RECHMPL20_0276
- Conditions
- Mental Disorder, General Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University of Montpellier 3 (Pr. Stéphane Raffard, PhD), University of Reims Champagne-Ardenne (Ali Oker PhD)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 12 May 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.
France has been put on a lockdown for 8 weeks to prevent the spread of the COVID-19 virus between 17/03/2020 and 11/05/2020. During this lockdown, which is likely to have psychopathological repercussions on the population, the public authorities and the media informed the population about the number of deaths occurring each day. While the functioning of autobiographical memory following traumatic events remains a debate in the literature, the impact of the daily announcement of mass deaths on the memory system in the general population and the relationship between long-term memory and delusional thinking in certain psychopathologies have yet to be explored in the literature.
The investigators wish to demonstrate that self-reported recall of recorded deaths may represent this distortion of perception, symptomatic of these pathologies by an on-line questionnaire.
Detailed description
Indeed, it has been reported that under continued stress, delusions and psychotic experiences can occur in the general population. This phenomenon is found in individuals suffering from depression and anxiety and schizotypal personality disorder.
The investigators wish to demonstrate that self-reported recall of recorded deaths may represent this distortion of perception, symptomatic of these pathologies.
Thus, using an online longitudinal questionnaire, the investigators wish to explore :
- how the memory system is impacted by mass deaths over several trimesters in the general population.
- whether the long-term memory of people suffering from depression and anxiety disorders and people suffering from schizotypal personality disorder contains recollection of a distorted pattern in relation to the actual number of deaths.
Primary goals of this project are:
Determine, in the context of mass deaths, the level and proportion of real or conceived recall of the number of deaths in the general population based on cognitive and affective empathy profiles over four trimesters.
Also the investigators want to determine
- the proportion of real or conceived recall numbers of deaths by COVID-19 among people suffering from depression and anxiety in a context of mass death.
- the proportion of real or conceived recall number of deaths by COVID-19 among people with schizotypal personality disorder.
- the dynamics of this real or conceived recall for four trimester following the end of lockdown.
Methodology:
The entire study will be conducted online. Participants will provide their informed consent. At these assessment, they will provide a set of self report measures associated to COVID-19 related psychological aspects especially for depression, anxiety and schizotypal personality.
Subjects can only participate once.
Sample size:
There is no minimum/maximum sample size for this study. The study will remain open for 1 year. The sample size should reach 1000 participants at least.
List of self-report measures:
- Brief Trauma Questionnaire (BTQ)
- COVID-Related Thoughts and Behavioral Symptoms (COV-TaBS)
- Beck Depression Inventory (BDI)
- State and Trait Anxiety Inventory (STAI)
- The Hospital Anxiety and Depression Scale (HAPS)
- Questionnaire of Cognitive and Affective Empathy (QCAE)
- Raine Schizotypal Personality Questionnaire, (SPQ)
- Paranoia Scale
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population with self reported depression, anxiety and schizotypal personnality and without mental health conditions
Key inclusion criteria (3 listed)
- Individuals from the general population
- French native speacker
- 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
number of perception distortions
Time frame: 1 day
number of perception distortions
1 secondary outcome
Recall number of deaths
Time frame: 1 day
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 11 Jan 2022.
- 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 and General Population, 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 11 Jan 2022. 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?
number of perception distortions (time frame: 1 day). 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 11 Jan 2022.