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COVID-19 and Mental Health in Eure

Assessment of Severe Depression Related to Psychotrauma in the COVID-19 Context in Patients Followed in Psychiatry in the Department of Eure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05364060
Acronym
COVID-SME
Enrollment
585
Registered
2022-05-06
Start date
2022-06-13
Completion date
2023-06-13
Last updated
2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pandemic, Psychiatric Disorder

Keywords

covid-19, psychiatry

Brief summary

Research Hypothesis: Living conditions during COVID-19, and lockdowns and curfews impact the psychological state of patients (assessed by the degree of depression, positive and negative thoughts, insomnia, state of post-traumatic stress).

Detailed description

From the early stages of the COVID-19 pandemic, concerns were raised about its effect on mental health and on patients with mental illness. Several surveys and cross-sectional assessments, in Italy, England, Ecuador and China in 2020, have suggested that patients with COVID-19 have symptoms of anxiety (including stress disorder traumatic, depression and insomnia. In France, a survey by Santé Publique France on the impact of COVID-19 on mental health carried out in November 2020, revealed a 20% rate of depressive symptoms in the general population. The objective of this study is to assess the level of psychological distress and the prevalence of psychiatric disorders related to COVID-19 as part of the follow-up of psychiatric patients in the department of Eure since March 2020, which has coincided with the onset of the health crisis, including consecutive lockdowns and curfews.

Interventions

OTHERQuestionnaires

Different questionnaires detailed in the objectives part

Sponsors

New Hospital of Navarre
CollaboratorUNKNOWN
Centre Hospitalier Eure-Seine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least 18 years old * Coming for a psychiatric consultation or hospitalization at the New Hospital of Navarre or in the extra-hospital centers of the department of Eure * Patient who has received the information note and who does not refuse to participate in the study

Exclusion criteria

* Patient not understanding French * Patient followed in psychiatry for a major cognitive disorder * Patient under legal protection measure (guardianship, curatorship, safeguard of justice, future protection mandate or family authorization)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of prevalence of severe depression in patients followed in psychiatry in the department of EureBaselineThe scale used is BDI-FS-Fr (Beck Depression Inventory-Fast Screen-French) scale, composed of seven self-assessment items taken from the 21 items of the BDI-II. The BDI-FS-Fr has been validated in France.

Secondary

MeasureTime frameDescription
Describe population characteristicsBaselineTypical demographic information such as age, gender, education level, current living situation, etc, and characteristics related to COVID-19
Evaluation of sleep disorderBaselineIt will be effectuated via the Insomnia Severity Index (ISI) that is a self-reported measure assessing the subjective symptoms and consequences of insomnia, as well as the degree of worry or distress caused by sleep difficulties. The French version of the ISI has also been validated.
Evaluation of post-traumatic stress disorderBaselineThe evaluation of post-traumatic stress disorder is performed via the SPAN (Startle, Physiological arousal, Anger, and Numbness) scale. The SPAN is a four-item scale for post-traumatic stress disorder that was empirically derived from the DTS (Davidson Trauma Scale). The minimum value for this scale is 0, the maximum, 16. Higher scores mean a worse outcome.
Evaluation of positive and negative thoughtsBaselineBoth positive and negative thoughts will be assessed using two positive and negative thought screening thermometers. Scoring is calculated from 0 to 10 for each scale.

Countries

France

Contacts

Primary ContactSorina Mihailescu, MD
sorina-dana.mihailescu@ch-eureseine.fr+33232338833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026