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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04384419
Other study ID # RECHMPL20_0276
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 29, 2020
Est. completion date June 1, 2021

Study information

Verified date January 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date June 1, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Individuals from the general population - French native speacker - Majority 18 years and more Exclusion criteria: - Patient refusing to participate in research

Study Design


Locations

Country Name City State
France UH Montpellier Montpellier

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Montpellier University of Montpellier 3 (Pr. Stéphane Raffard, PhD), University of Reims Champagne-Ardenne (Ali Oker PhD)

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of perception distortions number of perception distortions 1 day
Secondary Recall number of deaths Recall number of deaths 1 day
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