Clinical trial NCT04356885: COVID-19 and Psychotic Symptoms in France
Official title: Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorder
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Epsylon Laboratory, EA 4556, University Paul Valéry Montpellier 3, France
name: Laboratoy LIP/PC2S, University Grenobles-Alpes, Grenoble, France
name: Centre référent de réhabilitation psychosociale de Grenoble, Grenoble, France
First posted: 2020-04-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals from the general population with or without a mental disorder

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

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

Eligibility 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

Primary outcomes:
measure: Total score of the Cardiff Anomalous Perceptions Scale (CAPS)
timeFrame: inclusion, 1 week after inclusion and 1 month after inclusion
Secondary outcomes:
measure: Paranoia Scale
timeFrame: inclusion, 1 week after inclusion and 1 month after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Stéphane Raffard, PhD
role: PRINCIPAL_INVESTIGATOR
References: