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

• Conditions: Traumatic Stress Disorder; SARS-CoV 2

• Registration Number: NCT04405362
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-25
• Last Update Submitted: 2020-05-25
• Study First Posted: 2020-05-28
• Last Update Posted: 2020-05-28
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 753

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine	at 3 months after inclusion	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.

Secondary Outcome Measures

Name	Time	Method
Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)	at inclusion, then at 1 month and 3 months after inclusion	It's a Likert scale from 14 to 70. The higher the score, the higher the level of well-being.
IES-R (Impact of Events Scale Revised)	at inclusion, then at 1 month and 3 months after inclusion	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.
Total score at BDI (Beck Depression Inventory)	at inclusion, then at 1 month and 3 months after inclusion	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).
Total score at ISI (Insomnia Severity Index)	at inclusion, then at 1 month and 3 months after inclusion	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).
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
Socio-demographic factors significantly associated with all scores	at inclusion, then at 1 month and 3 months after inclusion	Socio-demographic factors, linked to medical history and the experience of the epidemic.
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	closed-ended question: Yes /No
Total score at GHQ-28 (General Health Questionnaire)	at inclusion, then at 1 month and 3 months after inclusion	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.