Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Death Number Perception in Depression, Anxiety, and Schizoypal Personnality in General Population (Covid-19 Pandemic) (DeathPercep)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384419
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
University of Montpellier 3 (Pr. Stéphane Raffard, PhD)
University of Reims Champagne-Ardenne (Ali Oker PhD)
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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.


Condition or disease
Mental Disorder General Population

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Real or Concieved Death Number Perception in Depression, Anxiety and in Schizotypal Personality Disorder Following Covid-19 Pandemic Lockdown
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. number of perception distortions [ Time Frame: 1 day ]
    number of perception distortions


Secondary Outcome Measures :
  1. Recall number of deaths [ Time Frame: 1 day ]
    Recall number of deaths


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
General population with self reported depression, anxiety and schizotypal personnality and without mental health conditions
Criteria

Inclusion criteria:

  • Individuals from the general population
  • French native speacker
  • Majority 18 years and more

Exclusion criteria:

  • Patient refusing to participate in research
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384419


Contacts
Layout table for location contacts
Contact: Stéphane Raffard, PhD 467339702 ext 33 s-raffard@chu-montpellier.fr
Contact: Ali Oker, PhD ali.oker@univ-reims.fr

Locations
Layout table for location information
France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Stéphane RAFFARD, PhD    0467339702 ext 33    s-raffard@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
University of Montpellier 3 (Pr. Stéphane Raffard, PhD)
University of Reims Champagne-Ardenne (Ali Oker PhD)
Investigators
Layout table for investigator information
Principal Investigator: Stéphane Raffard, PhD University Hospitals of Montpellier
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04384419    
Other Study ID Numbers: RECHMPL20_0276
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders