COVID-19 and Psychotic Symptoms in France (SCHIZOVID-19)
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|ClinicalTrials.gov Identifier: NCT04356885|
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : December 29, 2020
|Condition or disease|
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.
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
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
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|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|
- 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)
- 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
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
|Montpellier, France, 34295|
|Principal Investigator:||Stéphane Raffard, PhD||University Hospitals of Montpellier|