DepressionNCT05060445
Mental Health in Latin American Countries With Different Economic Incomes During the Covid-19 Pandemic.
An observational study of Depression and Anxiety, run by Universidad Westhill, Facultad de Psicología at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety, Substance-Related Disorders
- How many people
- 3,022 participants
- Where
- 1 siteMexico
- Study dates
- 22 Nov 2021to 13 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Población general latinoamericana hispanohablante de 18 a 65 años.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anxiety, Depression and Substance Use in Latin American Countries With Different Economic Incomes During the Covid-19 Pandemic.
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
Read the detailed 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.
- 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:
- 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.
- 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.
- Conditions
- Depression, Anxiety, Substance-Related Disorders
- Medical subject headings
- Depression, Anxiety Disorders, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start22 Nov 2021
- Primary completion22 Dec 2021
- Study completion13 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Westhill, Facultad de Psicología
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Hernández Posadas, Universidad Westhill, Facultad de Psicología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060445
- Sponsor's protocol ID
- UW/FP/IC/PSICOLOGIA/2021/001
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety, Depression and Substance Use in Latin American Countries With Different Economic Incomes During the Covid-19 Pandemic.
- ClinicalTrials.gov ID
- NCT05060445
- Acronym / sponsor ID
- UW/FP/IC/PSICOLOGIA/2021/001
- Conditions
- Depression, Anxiety, Substance-Related Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,022 participants (actual)
- Lead sponsor
- Universidad Westhill, Facultad de PsicologíaUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
- 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:
- 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.
- 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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Población general latinoamericana hispanohablante de 18 a 65 años.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 weeks
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.
Generalized Anxiety Disorder scale (GAD-7):
Time frame: 2 weeks
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.
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Universidad Westhill, Facultad de Psicología at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.