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PSYCHIATRIC Disorders and Covid-19 (PSYCHIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358042
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
Given the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (COVID-19), it seems particularly important to specify the impact of the COVID-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.

Condition or disease Intervention/treatment
Psychiatric Disorder Covid19 Other: Brief Psychiatric Rating Scale Other: Depression, Anxiety and Stress Scale Other: Impact of Event Scale-Revised Other: Connor-Davidson Resilience Scale 10 items (CD-RISC 10)

Detailed Description:

COVID-19's possible impact on psychiatric disorders has been little studied. However, patients with psychiatric disorders may be at higher risk of COVID-19 contamination, may experience delayed treatment when infected, may have a poor prognosis in terms of complications and success of treatment for COVID-19 but also for the underlying psychiatric disorder which could be exacerbated, and finally their psychotropic pharmacological treatment could be impacted by the inflammatory state linked to COVID-19.

The present study is an observatory of patients with psychiatric disorders and suspected to be infected by the COVID-19, hospitalized in a specific unit dedicated to the treatment of this comorbidity in the University Hospital of Nantes (France). The primary objective is to investigate the impact of the COVID-19 pandemic on the level of acute traumatic stress response. Secondary objectives include: (i) a description of the sample included; (ii) an assessment of the clinical evolution of these patients 4-6 weeks after admission; (iii) to investigate the links between the levels of stress, peritraumatic distress, and traumatic stress (whether it is acute or has evolved into a post-traumatic stress disorder (PTSD)); (iv) to investigate the links between resilience and coping on the one hand, and stress, peritraumatic distress and traumatic stress (acute or PTSD) on the other hand; and (v) to measure the impact of COVID infection and of the reduction on the residual plasma concentrations of psychotropic medications (especially antipsychotics and lithium).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: PSYCHIatric Disorders and Covid-19 (PSYCHIC) : Observatory of the Psychiatric, Somatic and Pharmacological Impacts of the COVID-19 Pandemic on Patients Hospitalized for Psychiatric Disorders and Suspected to be Infected by COVID-19
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders


Intervention Details:
  • Other: Brief Psychiatric Rating Scale
    The Abbreviated Psychiatric Rating Scale is a clinical scale for measuring symptomatic change in psychiatric inpatients for various conditions. It includes an accurate and complete description of the major characteristic symptoms. It is based both on patient responses and on observations made during the interview by the clinician. The usual reference period is the last two weeks.
  • Other: Depression, Anxiety and Stress Scale
    evaluation of 3 dimensions of psychological distress: depression, anxiety and stress. The scale consists of 21 items and the patient is instructed to choose for each item the one that best corresponds to his or her experience over the past week, on a scale of 0 ("does not apply to me at all") to 3 ("applies entirely to me, or the vast majority of the time"). A score is calculated for each dimension according to a predefined rating.
  • Other: Impact of Event Scale-Revised
    is a 22-item self-questionnaire that measures perceived stress in reference to a traumatic event during the previous 7 days. Each item is rated on a scale ranging from 0 (not at all) to 4 (extremely) and 3 sub-scores of post-traumatic symptoms are calculated: Revivification, Avoidance, Psychophysiological Activation, as well as a total score of severity of the state of stress. Acute Stress Disorder (ASD) and Post-Traumatic Stress Disorder (PTSD) share the same symptoms, the former lasting between 3 days and one month, while the latter is diagnosed when symptoms persist beyond one month. Since the exposure to the stressful event will have occurred less than a month ago, this questionnaire here will help identify a state of acute stress. A total R-ESI score equal to or greater than 33 suggests a significant level of symptoms
  • Other: Connor-Davidson Resilience Scale 10 items (CD-RISC 10)
    Self-questionnaire composed of 10 items, evaluating the resilience capacities of patients. Resilience may act as a moderator against the symptoms of PTSD. This instrument uses a 5-point Likert-type response scale ranging from 0 "Not true at all" to 4 "True most of the time".


Primary Outcome Measures :
  1. impact of the COVID-19 pandemic on psychiatric symptomatology [ Time Frame: through study completion, an average of 2 year ]
    total severity score from the Impact of Event Scale-Revised (IES-R)


Biospecimen Retention:   None Retained
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with psychiatric disorders and suspected to be infected by the COVID-19, hospitalized in a specific unit dedicated to the treatment of this comorbidity in the University Hospital of Nantes (CHU Nantes).
Criteria

Inclusion Criteria:

  • All patients hospitalized in the PROTECTION COVID-19 PSY unit from the Nantes University Hospital may be included, without maximum age limit.

Minors, pregnant or nursing women, and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study (observatory)

Exclusion Criteria:

  • minors under 15 years;
  • safeguard of justice;
  • inability to consent (non-opposition);
  • not mastering the reading and writing of the French language well enough.

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): NCT04358042


Contacts
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Contact: Marie GRALL-BRONNEC 02.40.84.76.20 ext +(33) marie.bronnec@chu-nantes.fr
Contact: Gaelle CHALLET 02 40 84 76 20 ext +(33) gaelle.bouju@chu-nantes.fr

Locations
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France
Nantes University Hospital - IFAC Recruiting
Nantes, France, 44093
Contact: Marie Grall-Bronnec, PU-PH    +33240847620    marie.bronnec@chu-nantes.fr   
Principal Investigator: Marie Grall-Bronnec, PH PhD         
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04358042    
Other Study ID Numbers: RC20_0165
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 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 Nantes University Hospital:
Psychiatry
COVID-19
psychological impact
acute stress, pharmacological impact
pharmacological impact
Additional relevant MeSH terms:
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Disease
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms