Study Results
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.
COMPLETED
78 participants
OBSERVATIONAL
2021-10-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic
NCT04823988
COVID-19 and Psychotic Symptoms in France
NCT04356885
Death Number Perception in Depression, Anxiety, and Schizoypal Personnality in General Population (Covid-19 Pandemic)
NCT04384419
PSYCHIATRIC Disorders and Covid-19
NCT04358042
COVID-19 & Psychiatry: A Retrospective Chart Review
NCT05244096
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
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
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Autonoma de Coahuila
OTHER
Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lilia Edith Luque Esparza
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
Countries
Review the countries where the study has at least one active or historical site.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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.