NCT04356885

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

April 19, 2020

Last Update Submit

December 28, 2020

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (1)

  • Total score of the Cardiff Anomalous Perceptions Scale (CAPS)

    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)

    inclusion, 1 week after inclusion and 1 month after inclusion

Secondary Outcomes (1)

  • Paranoia Scale

    inclusion, 1 week after inclusion and 1 month after inclusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals from the general population with or without a mental disorder

You may qualify if:

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

You may not qualify if:

  • Patient refusing to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Stéphane Raffard, PhD

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

April 1, 2020

Primary Completion

July 30, 2020

Study Completion

August 1, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

FR(1)