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

SARS-CoV 2 Clinical Trial

— QUARCOPSY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04405362
• Other study ID #: 2020_39
• Secondary ID: 2020-A01186-33
• Status: Not yet recruiting
• Start date: May 2020
• Est. completion date: May 2021

Study information

• Verified date: April 2020
• Source: University Hospital, Lille
• Contact: Arnaud Leroy, MD
• Phone: 03 20 44 44 60
• Email: arnaud.leroy[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 753
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV 2
• Stress Disorders, Traumatic
• Traumatic Stress Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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