PSYCHIATRIC Disorders and Covid-19

NCT04358042 | Terminated

• 1 other identifier: RC20_0165
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder; Covid19

Keywords

Psychiatry; COVID-19; psychological impact; acute stress, pharmacological impact; pharmacological impact

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Brief Psychiatric Rating Scale OTHER

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.

Depression, Anxiety and Stress Scale OTHER

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.

Impact of Event Scale-Revised OTHER

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

Connor-Davidson Resilience Scale 10 items (CD-RISC 10) OTHER

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".

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital - IFAC

Nantes, Loire-Atlantique, 44093, France

Location

Biospecimen

Retention: NONE RETAINED

Blood

MeSH Terms

Conditions

Mental Disorders; COVID-19

Interventions

Brief Psychiatric Rating Scale

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Psychiatric Status Rating Scales; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 22, 2020
• Study Start: April 24, 2020
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

FR (1)