Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry (QUARCOPSY)

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.

Study Overview

• Status: Unknown
• Conditions: SARS-CoV 2; Traumatic Stress Disorder

• Study Type: Observational
• Enrollment (Anticipated): 753

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
IES-R (Impact of Events Scale Revised)	This self-questionnaire is intended to measure subjective post-traumatic stress after a traumatic situation (within 7 days) but is not a diagnostic tool. It includes 22 items rated from 0 (not at all) to 4 (extremely). There are 3 sub-scales: an avoidance subscale (items 5, 7, 8, 11, 12, 13, 17, 22): the sum of the scores on each of these items ranges from 0 to 35;; Memory intrusion subscale (items 1, 2, 3, 6, 9, 14, 16 and 20): the sum of the scores on each of these items ranges from 0 to 40;; a Hyperarousal/High Neurovegetative Activation subscale (items 4, 10, 15, 18, 19 and 21): the sum of the scores on each of these items ranges from 0 to 35. A total score of at least 22 suggests the presence of significant symptoms of acute stress. A score of 36 and above suggests the presence of post-traumatic stress disorder.	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	closed-ended question: Yes /No	at inclusion, then at 1 month and 3 months after inclusion
Total score at GHQ-28 (General Health Questionnaire)	questionnaire with a 28 item scaled and assesses somatic symptoms, anxiety and insomnia, social dysfunction and severe depression that ranges from a 'better/healthier than normal' option, through a 'same as usual' and a 'worse/more than usual' to a 'much worse/more than usual' option. The exact wording will depend upon the particular nature of the item.	at inclusion, then at 1 month and 3 months after inclusion
Total score at BDI (Beck Depression Inventory)	13 questions rated from 0 to 3 to obtain a score from 0 to 39 The higher the score, the greater the symptomatology: 0 to 3 (no depression), 4 to 7 (mild depression), 8 to 15 (depression of moderate to moderate intensity), greater than 16 (severe depression).	at inclusion, then at 1 month and 3 months after inclusion
Total score at ISI (Insomnia Severity Index)	7 questions rated from 0 to 4 to obtain a score from 0 to 28 The higher the score, the greater the symptomatology: 0 to 7 (no insomnia), 8 to 14 (mild insomnia), 15 to 21 (moderate insomnia), 22 to 28 (severe insomnia).	at inclusion, then at 1 month and 3 months after inclusion
Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period		at inclusion, then at 1 month and 3 months after inclusion
Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)	It's a Likert scale from 14 to 70. The higher the score, the higher the level of well-being.	at inclusion, then at 1 month and 3 months after inclusion
Socio-demographic factors significantly associated with all scores	Socio-demographic factors, linked to medical history and the experience of the epidemic.	at inclusion, then at 1 month and 3 months after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Arnaud Leroy, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; quarantine; Psychiatric Traumatic Stress Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; COVID-19; Stress Disorders, Traumatic
• Other Study ID Numbers: 2020_39; 2020-A01186-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No