COVID-19 Severity and Psychiatric Morbidity

March 16, 2023 updated by: Lilia Edith Luque Esparza, Instituto Mexicano del Seguro Social

Association of the Severity of the Clinical Picture of COVID-19 and Psychiatric Morbidity

The COVID-19 pandemic represents the most serious global health threat since the Spanish influenza, with repercussions on physical and mental health. The balance between physical and mental state is essential when establishing treatment for a critically ill patient and must be taken into account by health professionals. Therefore, the investigators hypothesize that there is an association between the severity of the clinical picture of COVID-19 and psychiatric morbidity.

Objective. Associate the severity of the clinical picture of COVID-19 with psychiatric morbidity.

Material and method. Hospitalized participants in the COVID respiratory area at the General Hospital of the Zone will be included. # 51 of Gómez Palacio, Dgo. in the period from October 1, 2021 to March 31, 2022. This is an epidemiological, observational, prospective, longitudinal, analytical study. Sociodemographic, clinical and psychiatric evaluation data will be obtained using GMHAT / PC. A statistical analysis will be carried out using descriptive statistics (frequencies, measures of central tendency and dispersion) and analytical, to evaluate the association (Chi2) and to evaluate the effect of the intervening variables (binary logistic regression and multivariate regression). The data will be analyzed in the SPSS version 21 program.

Study Overview

Status

Completed

Conditions

Detailed Description

Subjects who meet selection criteria entered into the COVID area will be included in the period from October 1, 2021 to March 31, 2022. A non-probabilistic convenience sampling will be carried out, occluding all patients who agree to participate and meet the criteria of selection.

Patients entering the COVID area will be invited to participate in the study. Participants will be questioned about the selection criteria, and if they are eligible to be included in the study, they will be given the letter of informed consent for reading, clarification of doubts and signature. Each participant will receive a copy of the informed consent letter, this copy will remain in the COVID area until the participant is discharged. The researcher's copy will be handled under the biosafety standards established in the institute for materials and documents in contact with COVID patients.

Information about their general data and conventional medical history will be obtained through direct questioning and review of the medical record and a brief neuropsychiatric evaluation will be performed. The severity data of the COVID clinical picture and clinical evolution will be obtained from the records in the electronic medical record. The evaluation of psychiatric morbidities using the GMHAT / PC will be carried out later, prior to feeding the database.

The information obtained will be emptied into an Excel database for subsequent statistical analysis with the IBM SPSS STATISTICS program. The information of the study will remain confidential, the identity of the participants will be protected through the use of the initials of the participant's name. The data collected will be in charge of the researcher for safekeeping. The management of the information from the data collection sheets will be organized by folios.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Durango
      • Gómez Palacio, Durango, Mexico, 35025
        • Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Beneficiaries admitted to the COVID respiratory area of HGZ No.51 in the period from October 01, 2021 to March 31, 2022.

Description

Inclusion Criteria:

  • Beneficiaries in the COVID respiratory area of HGZ No.51
  • COVID-19 diagnosis confirmed by PCR.
  • Complete neuropsychiatric medical history data that allows the evaluation of the psychiatric status using GMHAT / PC
  • Accept to participate in the study and sign the informed consent.

Exclusion Criteria:

  • Pre-existing neuropsychiatric diseases and under psychiatric medical treatment.
  • History of psychotropic use and / or withdrawal syndrome.
  • Incomplete file data or that do not allow the assessment of the severity of the clinical picture of COVID-19 upon admission to the respiratory area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with a diagnosis of COVID-19

A directed psychiatric evaluation will be carried out and 1 evaluation instrument will be applied: Global Tool for the Evaluation of Mental Health in Primary Care (GMHAT / PC).

The Global Mental Health Assessment Tool / Primary Care (GMHAT / PC) is a computerized, semi-structured clinical interview tool developed to assess and identify mental health problems. The main diagnosis derives from the use of a hierarchical model based on ICD-10. The diagnostic program takes into account the severity of symptoms (moderate to severe). It also generates alternative diagnoses and comorbidity states based on the presence of symptoms of other disorders. In addition, it includes a suicide risk assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of severity of the clinical picture of COVID-19
Time Frame: Duration of hospitalization (20 days)
Severity of COVID-19 according to the clinical and paraclinical parameters established by the WHO (Mild, Moderate, Severe, Critical)
Duration of hospitalization (20 days)
Number of participants with depression
Time Frame: Duration of hospitalization (20 days)
According to the result of the psychiatric evaluation using GMHAT/PC: Absent or Present
Duration of hospitalization (20 days)
Number of participants with anxiety
Time Frame: Evaluation at hospital admission (2 hours)
According to the result of the psychiatric evaluation using GMHAT/PC: Absent or Present
Evaluation at hospital admission (2 hours)
Number of participants with panic disorder
Time Frame: Evaluation at hospital admission (2 hours)
According to the result of the psychiatric evaluation using GMHAT/PC: Absent or Present
Evaluation at hospital admission (2 hours)
Number of participants with psychosis
Time Frame: Evaluation at hospital admission (2 hours)
According to the result of the psychiatric evaluation using GMHAT/PC: Absent or Present
Evaluation at hospital admission (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evolution of the participants measured by clinical and paraclinical parameters
Time Frame: Duration of hospitalization (20 days)
Worsening or improvement of the disease measurable by observable and diagnosable signs and symptoms according to the clinical and paraclinical parameters established by the WHO.
Duration of hospitalization (20 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Collaborators

Universidad Autonoma de Coahuila

Investigators

  • Principal Investigator: Lilia E Luque Esparza, Dra., IMSS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2021-902-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This item has not yet been defined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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