COVID-19 and Psychotic Symptoms in France

NCT ID: NCT04356885

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-08-01

Brief Summary

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Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.

Detailed Description

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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

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Mental Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Individuals from the general population with or without a mental disorder
* French native speaker
* Majority 18 years and more

Exclusion Criteria

* Patient refusing to participate in research
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Epsylon Laboratory, EA 4556, University Paul Valéry Montpellier 3, France

UNKNOWN

Sponsor Role collaborator

Laboratoy LIP/PC2S, University Grenobles-Alpes, Grenoble, France

UNKNOWN

Sponsor Role collaborator

Centre référent de réhabilitation psychosociale de Grenoble, Grenoble, France

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Raffard, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0225

Identifier Type: -

Identifier Source: org_study_id