PSYCHIATRIC Disorders and Covid-19 (PSYCHIC)

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; Psychiatric Disorder
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes University Hospital - IFAC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of the COVID-19 pandemic on psychiatric symptomatology	total severity score from the Impact of Event Scale-Revised (IES-R)	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Psychiatry; psychological impact; acute stress, pharmacological impact; pharmacological impact
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Disease; Problem Behavior; Mental Disorders
• Other Study ID Numbers: RC20_0165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No