Clinical trial NCT05124158: COVID-19 Severity and Psychiatric Morbidity
Official title: Association of the Severity of the Clinical Picture of COVID-19 and Psychiatric Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Psychiatric Disorder
Keywords: COVID-19
Psychiatric morbidity
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Autonoma de Coahuila
First posted: 2021-11-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of severity of the clinical picture of COVID-19
timeFrame: Duration of hospitalization (20 days)
measure: Number of participants with depression
timeFrame: Duration of hospitalization (20 days)
measure: Number of participants with anxiety
timeFrame: Evaluation at hospital admission (2 hours)
measure: Number of participants with panic disorder
timeFrame: Evaluation at hospital admission (2 hours)
measure: Number of participants with psychosis
timeFrame: Evaluation at hospital admission (2 hours)
Secondary outcomes:
measure: Clinical evolution of the participants measured by clinical and paraclinical parameters
timeFrame: Duration of hospitalization (20 days)
Other outcomes:
Locations:
city: Gómez Palacio
country: Mexico
facility: Instituto Méxicano del Seguro Social
state: Durango
Study officials:
affiliation: IMSS
name: Lilia E Luque Esparza, Dra.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shigemura J, Ursano RJ, Morganstein JC, Kurosawa M, Benedek DM. Public responses to the novel 2019 coronavirus (2019-nCoV) in Japan: Mental health consequences and target populations. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-282. doi: 10.1111/pcn.12988. Epub 2020 Feb 23. No abstract available.
citation: Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.