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

Study Overview
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Brief Summary
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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.

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

Conditions
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SARS-CoV 2, Traumatic Stress Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, quarantine, Psychiatric Traumatic Stress Disorder