NCT04405362

Brief Summary

Quarantine related to the Covid-19 pandemic has begun on the 03/17/2020 in France. Quarantine has already be linked to pejorative effects on mental health. In this study, we aim to evaluated PTSD symptoms of patients already followed by a psychiatrist during quarantine, one month and 3 months after inclusion. It will be also evaluate various psychiatric symptoms.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Status
withdrawn

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

May 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

May 18, 2020

Last Update Submit

December 17, 2025

Conditions

SARS-CoV 2Traumatic Stress Disorder

Keywords

COVID-19quarantinePsychiatric Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

  • Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

    PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

    at inclusion

  • Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

    PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

    at 1 month after inclusion

  • Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

    PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) (6). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

    at 3 months after inclusion

Secondary Outcomes (8)

  • IES-R (Impact of Events Scale Revised)

    at inclusion, then at 1 month and 3 months after inclusion

  • Presence of suicidal ideation during the past month at the different times of the study

    at inclusion, then at 1 month and 3 months after inclusion

  • Total score at GHQ-28 (General Health Questionnaire)

    at inclusion, then at 1 month and 3 months after inclusion

  • Total score at BDI (Beck Depression Inventory)

    at inclusion, then at 1 month and 3 months after inclusion

  • Total score at ISI (Insomnia Severity Index)

    at inclusion, then at 1 month and 3 months after inclusion

  • +3 more secondary outcomes

Eligibility Criteria

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

patient with psychotic disorder, mood disorders, labile emotional personality disorder, anxiety disorders and somatoform disorders

You may qualify if:

  • Patients already followed in psychiatry before quarantine by one of the psychiatrists subscribed to L'Encéphale online.

You may not qualify if:

  • Refusal to complete the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, TraumaticCOVID-19

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Arnaud Leroy, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 28, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

December 23, 2025

Record last verified: 2025-12