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SARS-CoV 2QUARCOPSYNCT04405362

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

An observational study of SARS-CoV 2 and Traumatic Stress Disorder, run by University Hospital, Lille.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV 2, Traumatic Stress Disorder
How many people
0 participants
Where
No sites listed yet
Study dates
May 2020to May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Patients already followed in psychiatry before quarantine by one of the psychiatrists subscribed to L'Encéphale online.

Who cannot join

  • Refusal to complete the questionnaire

About this study

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.

Keywords
COVID-19, quarantine, Psychiatric Traumatic Stress Disorder
Medical subject headings
Stress Disorders, Traumatic, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at inclusion

  2. 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.

    Measured: at 1 month after inclusion

  3. 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.

    Measured: at 3 months after inclusion

Secondary outcomes (8)

  1. 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.

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  2. Presence of suicidal ideation during the past month at the different times of the study

    closed-ended question: Yes /No

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  3. 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.

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  4. 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).

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  5. 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).

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  6. Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  7. 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.

    Measured: at inclusion, then at 1 month and 3 months after inclusion

  8. Socio-demographic factors significantly associated with all scores

    Socio-demographic factors, linked to medical history and the experience of the epidemic.

    Measured: at inclusion, then at 1 month and 3 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study startMay 2020 (estimated)
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Why it stopped: NO INCLUSION

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04405362
Sponsor's protocol ID
2020_39
Other IDs
2020-A01186-33
Acronym
QUARCOPSY
Status last verified
Dec 2025
First submitted
18 May 2020
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV 2 and Traumatic Stress Disorder, run by University Hospital, Lille.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04405362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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