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Clinical Trial Summary

A study will be conducted with a quantitative approach with correlational scope, observational analytical study, prospective cross-country study. The objective is to detect the prevalence of anxious and depressive symptomatology and substance use during the Third Wave of the Covid-19 Pandemic in the general Spanish-speaking Latin American population aged 18 to 65 years.


Clinical Trial Description

Sampling: A non-experimental sampling by volunteer subjects is performed, since the subjects will come to the study by a call on social networks. Data management plan: Data dictionary design Training will be provided and data dictionary will be developed describing the properties of variables such as data type (e.g. string and number), variable size, data encoding, and constraints and validations attached to a given variable (Annex). Data collection The research data will be obtained through the Survey Monkey application, which has "SOC 2" accreditation that meet best practices and security, as they are transmitted over a secure HTTPS connection and that user logins were protected through TLS. Furthermore, data is encrypted using industry and research standard encryption algorithms. Data Retention The database will be generated in Excel for further analysis in R studio, which will be kept at the University on an encrypted USB stick for data security and the password to this stick will only be held by the project manager. Standards that provide data integrity, accuracy and coherence The International Classification of Diseases (ICD- 11) will be used to present data consistency, accuracy and completeness through the optimal definition of mental health entities. On the other hand, the standards for data use recommended by The Global Health Training Centre will be used: (a) The column heading (variable) is not changed between data. b) The same terminology is maintained for all variables. c) There is a consistent format and standard definition for subject identification. d) The name of the datasets is always the same. e) Name of the form / CRF section, e.g., demographic data f) A list of data objects (names and definitions) g) Description of the data element in natural language h) Detailed properties of the data elements (data type, size, nullability, optionality, indexes) i) Response options, e.g., check box, radio button, text j) Validation rule(s), e.g., required field, range checking k) Relationship of data elements to other data elements. l) Details about the privacy and security restrictions that should be associated with the element, e.g., Protected Health Information status. Scenario: The evaluation will be carried out in the application called Survey Monkey and will be distributed through social networks. Blinding procedure of the study: A double-blind study will be conducted based on the recommendations of Parker & Berman (2014), which mention that two stages will be carried out for this purpose: 1. There will be a psychologist who will apply the elimination criteria to the initial sample and will send it to the system for the encryption of a usb memory stick that the data analyst will receive. 2. There will be a psychologist who will participate in the abstraction and analysis of the data to be used, who will send the collection data to the methodologists who will interpret them with the data dictionary. Methodological guidelines for reporting the study: The guide to improve the quality of methodological reporting of cross-sectional online studies called CHERRIE will be used. Sample size: The infinite population formula for qualitative variables will be used, since we will be working with ordinal variables. In addition to the fact that the total number of observation units is unknown or when the population is greater than 100,000. The sample size for 100,000 persons should be 384 persons per country, so that 95% of the time the data to be measured is within the ±5% interval with respect to the data observed in the evaluation. Data analysis: Descriptive statistics will be used to analyze the central tendency frequencies of the participants' characteristics. Data homogeneity and sample distribution analyses will be applied to decide whether to apply parametric or nonparametric statistics for related samples. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05060445
Study type Observational
Source Universidad Westhill, Facultad de Psicología
Contact Alejandro Hernández Posadas, Master's degree
Phone +52 5588517000
Email [email protected]
Status Not yet recruiting
Phase
Start date December 15, 2021
Completion date April 20, 2022

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