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Completed

NCT Number: NCT05124158

COVID-19 Severity 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral Psychiatric Disorder RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Méxicano del Seguro Social

Gómez Palacio, Durango, 35025, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Collaborators

  • Universidad Autonoma de Coahuila

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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