NCT05060445

Brief Summary

The Covid-19 pandemic has generated, in the Latin American population, unprecedented levels of anxiety, depression and substance use associated with the diagnosis of the disease. Consequently, it has been pointed out that a moderating variable for the appearance of these psychological problems is high social and economic vulnerability. OBJECTIVE: To assess differences in psychological problems exposed to the diagnosis of Covid-19 by groups of countries with different incomes. METHODOLOGY: A non-experimental, correlational, prospective, double-blind, cross-sectional study was carried out using the CHERRIES methodological criteria and the sample was Latin American people. The scales used were for depression (PHQ-9), anxiety (GAD-7) and substance use (ASSIST). Likewise, Latin American countries were classified by their income level according to the World Bank. Also, the Shapiro-Wilk normality test and an ANOVA analysis of variance were performed, with Post Hoc test, with Bonferroni adjustment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,022

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2022

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

September 9, 2021

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9)

    It is a cross-culturally validated instrument and its confirmatory factor analysis suggested that the one-factor structure was a reasonably good fit. The internal consistency of the PHQ-9 was good (Cronbach's alpha\> = 0.8) overall and for subgroups defined by gender, literacy, and age. The PHQ-9 demonstrated good predictive validity: participants with a PHQ-9 diagnosis of depression had lower quality of life scores on the overall WHOQOL-BREF scale and on each of its domains. Using the results of the PHQ-9 as a gold standard, the optimal cut-off score of 10. Definition of the variable: A depressive episode is characterized by a period of depressed mood or decreased interest in activities occurring most of the day, almost every day for a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating, feelings of worthlessness or excessive or inappropriate guilt.

    2 weeks

  • Generalized Anxiety Disorder scale (GAD-7):

    The GAD-7 consists of the 7 items with the highest correlation with the total score of the 13-item scale (r = 0.75-0.85). It is an instrument with cross-cultural validation and analysis of receiver operating characteristics with this set of items showed an area under the curve (0.906) and scales with as much as the full 13-item set. These 7 items also had the highest rank correlations in the development sample (n = 1184) and the 2 replication samples (n = 965 and n = 591). The 2 core criteria (A and B) of the DSM-IV definition of GAD are captured by the first 3 items of the scale.26 Of note, 6 of the 7 items had the highest divergent validity (ie, the largest difference between item-total scale score correlation and item-PHQ-8 depression score correlation \[Δ r = 0.16-0.21\]). Because each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21.

    2 weeks

  • Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    Validation and cultural adaptation was carried out in university students through a non-experimental ex post facto study with 1,176 undergraduate students, mostly women (70.1%) aged 18 to 23 years (89.5%) and unmarried (87.5%). Concurrent validity was obtained by factor analysis and reliability and correlation tests between the alcohol subscale and AUDIT, the Tobacco subscale and Fargerström's Tes, and the marijuana subscale and the DAST-20. The results found adequate reliability coefficients for the ASSIST subscales for tobacco (alpha = 0.83), alcohol (alpha = 0.76) and marijuana (alpha = 0.73). Regarding interscale correlation, significant correlations were only found with the AUDIT (r = 0.71) and the alcohol subscale.

    3 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Población general latinoamericana hispanohablante de 18 a 65 años.

You may qualify if:

  • Living in Latin America during the Covid-19 pandemic
  • Be between 18 and 65 years of age
  • Be able to read and write
  • Be a native Spanish speaker
  • Agree to voluntarily participate in the study

You may not qualify if:

  • Persons receiving psychological or psychiatric treatment during the study period.
  • Persons who have suffered the loss of a family member in at least 1 month prior to the Covid-19 evaluation.
  • Persons who have migrated to another Latin American country in at least 6 months.
  • Persons who have been hospitalized in the last month.
  • Persons who reside in Latin America, but are not natives.
  • Have a confirmed diagnosis of Covid-19 within the last 2 weeks.
  • Persons who are minors or over 65 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westhill University

Mexico City, 010, Mexico

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersChemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full-time teacher and researcher.

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 29, 2021

Study Start

November 22, 2021

Primary Completion

December 22, 2021

Study Completion

March 13, 2022

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations