COVID-19 Severity and Psychiatric Morbidity

NCT05124158 | Completed DMC

• 1 other identifier: R-2021-902-025
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Psychiatric Disorder

Keywords

COVID-19; Psychiatric morbidity

Outcome Measures

Primary Outcomes (5)

• 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)

• Number of participants with depression

  According to the result of the psychiatric evaluation using GMHAT/PC: Absent or Present

  Duration of hospitalization (20 days)

• 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)

• 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)

• 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 Outcomes (1)

• Clinical evolution of the participants measured by clinical and paraclinical parameters

  Duration of hospitalization (20 days)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Universidad Autonoma de Coahuila: collaborator

Study Sites (1)

Instituto Méxicano del Seguro Social

Gómez Palacio, Durango, 35025, Mexico

Location

Related Publications (6)

• 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.

  PMID: 32592501 BACKGROUND

• 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.

  PMID: 32754159 BACKGROUND

• 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.

  PMID: 23122486 BACKGROUND

• 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.

  PMID: 22221976 BACKGROUND

• 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.

  PMID: 32034840 BACKGROUND

• 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.

  PMID: 32112714 BACKGROUND

Related 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

MeSH Terms

Conditions

COVID-19; Mental Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lilia E Luque Esparza, Dra.

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 17, 2021
• Study Start: October 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)