Clinical trial NCT04405362: Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry
Official title: Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV 2
Traumatic Stress Disorder
Keywords: COVID-19
quarantine
Psychiatric Traumatic Stress Disorder
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 753
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with psychotic disorder, mood disorders, labile emotional personality disorder, anxiety disorders and somatoform disorders

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal to complete the questionnaire

Primary outcomes:
measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine
timeFrame: at inclusion
measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine
timeFrame: at 1 month after inclusion
measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine
timeFrame: at 3 months after inclusion
Secondary outcomes:
measure: IES-R (Impact of Events Scale Revised)
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Presence of suicidal ideation during the past month at the different times of the study
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Total score at GHQ-28 (General Health Questionnaire)
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Total score at BDI (Beck Depression Inventory)
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Total score at ISI (Insomnia Severity Index)
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
measure: Socio-demographic factors significantly associated with all scores
timeFrame: at inclusion, then at 1 month and 3 months after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Arnaud Leroy, MD
role: PRINCIPAL_INVESTIGATOR
References: