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COVID-19 and Psychotic Symptoms in France (SCHIZOVID-19)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356885
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : December 29, 2020
Sponsor:
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
Information provided by (Responsible Party):
University Hospital, Montpellier

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

Condition or disease
Mental Disorder

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

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Paranoia Scale [ Time Frame: inclusion, 1 week after inclusion and 1 month after inclusion ]

    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




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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals from the general population with or without a mental disorder
Criteria

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

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): NCT04356885


Locations
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France
UH Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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
Investigators
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Principal Investigator: Stéphane Raffard, PhD University Hospitals of Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04356885    
Other Study ID Numbers: RECHMPL20_0225
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders