COVID-19 Severity and Psychiatric Morbidity

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124158
• Other study ID #: R-2021-902-025
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Locations

Country	Name	City	State
Mexico	Instituto Méxicano del Seguro Social	Gómez Palacio	Durango

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social	Universidad Autonoma de Coahuila

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Bhaskar S, Sinha A, Banach M, Mittoo S, Weissert R, Kass JS, Rajagopal S, Pai AR, Kutty S. Cytokine Storm in COVID-19-Immunopathological Mechanisms, Clinical Considerations, and Therapeutic Approaches: The REPROGRAM Consortium Position Paper. Front Immunol. 2020 Jul 10;11:1648. doi: 10.3389/fimmu.2020.01648. eCollection 2020. — View 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. — View Citation

Hu B, Huang S, Yin L. The cytokine storm and COVID-19. J Med Virol. 2021 Jan;93(1):250-256. doi: 10.1002/jmv.26232. Epub 2020 Sep 30. — View Citation

Ryerson CJ, Arean PA, Berkeley J, Carrieri-Kohlman VL, Pantilat SZ, Landefeld CS, Collard HR. Depression is a common and chronic comorbidity in patients with interstitial lung disease. Respirology. 2012 Apr;17(3):525-32. doi: 10.1111/j.1440-1843.2011.02122.x. — View Citation

Sharma BB, Singh S, Sharma VK, Choudhary M, Singh V, Lane S, Lepping P, Krishna M, Copeland J. Psychiatric morbidity in chronic respiratory disorders in an Indian service using GMHAT/PC. Gen Hosp Psychiatry. 2013 Jan-Feb;35(1):39-44. doi: 10.1016/j.genhosppsych.2012.09.009. Epub 2012 Oct 31. — View 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. — View Citation

Outcome

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

External Links

•   Secretaria de la Salud. Lineamientos De Respuesta Y De Acción En Salud Mental Y Adicciones Para El Apoyo Psicosocial Durante La Pandemia Por Covid-19 En Méxic