COVID-19 Severity and Psychiatric Morbidity

NCT ID: NCT05124158

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Psychiatric Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Autonoma de Coahuila

OTHER

Sponsor Role collaborator

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lilia Edith Luque Esparza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lilia E Luque Esparza, Dra.

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Méxicano del Seguro Social

Gómez Palacio, Durango, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32592501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32754159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23122486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22221976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32034840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32112714 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.gob.mx/salud/documentos/lineamientos-y-documentos-de-apoyo-en-salud-mental-y-adicciones-ante-el-covid-19

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R-2021-902-025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.