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

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ClinicalTrials.gov Identifier: NCT04405362
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
SARS-CoV 2 Traumatic Stress Disorder

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Study Type : Observational
Estimated Enrollment : 753 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health




Primary Outcome Measures :
  1. Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine [ Time Frame: at inclusion ]
    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.

  2. Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine [ Time Frame: at 1 month after inclusion ]
    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.

  3. Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine [ Time Frame: 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 :
  1. IES-R (Impact of Events Scale Revised) [ Time Frame: 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.


  2. Presence of suicidal ideation during the past month at the different times of the study [ Time Frame: at inclusion, then at 1 month and 3 months after inclusion ]
    closed-ended question: Yes /No

  3. Total score at GHQ-28 (General Health Questionnaire) [ Time Frame: 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.

  4. Total score at BDI (Beck Depression Inventory) [ Time Frame: 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).

  5. Total score at ISI (Insomnia Severity Index) [ Time Frame: 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).

  6. Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period [ Time Frame: at inclusion, then at 1 month and 3 months after inclusion ]
  7. Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) [ Time Frame: 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.

  8. Socio-demographic factors significantly associated with all scores [ Time Frame: at inclusion, then at 1 month and 3 months after inclusion ]
    Socio-demographic factors, linked to medical history and the experience of the epidemic.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with psychotic disorder, mood disorders, labile emotional personality disorder, anxiety disorders and somatoform disorders
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405362


Contacts
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Contact: Arnaud Leroy, MD 03 20 44 44 60 arnaud.leroy@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Arnaud Leroy, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04405362    
Other Study ID Numbers: 2020_39
2020-A01186-33 ( Other Identifier: ID-RCB number,ANSM )
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
COVID-19
quarantine
Psychiatric Traumatic Stress Disorder
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders