Major Depressive DisorderSTRINGNCT04114565
Prevalence of Major Depression Among Immigrants in Santiago, Chile
An observational study of Major Depressive Disorder, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the Metropolitan Region of Santiago, Chile. The hypotheses are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 1,092 participants
- Where
- 1 siteChile
- Study dates
- 29 Jul 2019to 30 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults residing in private households in the Metropolitan Region of Santiago, Chile who were born outside of Chile and have lived in the country for at least 3 months
Who may be able to join
- Country of birth other than Chile
- Time since arrival to Chile: 3 months
Who cannot join
- Unable to understand Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Santiago Immigrant Wellbeing Study (STRING): Prevalence of Mood Disorders Among Immigrants in Santiago, Chile
The general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the Metropolitan Region of Santiago, Chile.
The hypotheses are:
Read more
- A healthy immigrant effect will be observed in the studied population by which their prevalence of major depressive disorder will be lower than the prevalence in the general Chilean population.
- A significant association will be observed between the loss of socio-economic position after migration and a greater probability of major depressive disorder.
- A significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of major depressive disorder.
- A significant association will be observed between financial difficulties and a greater probability of major depressive disorder.
The sampling framework of the Chilean National Institute of Statistics (INE) from the 2016 Census will be used for the purpose of this research. The sampling units are as follows:
- Primary sampling units (PSUs): conglomerates or groups of adjoining houses, organized in spatial blocks (200 households on average)
- Secondary sampling units (SSUs): individual households within each of the conglomerates selected in the first stage
- Final sampling units: persons meeting the study's inclusion criteria Multi-stage random probability sampling involving a 3-stage sampling design will be used - first, the sampling of the primary sampling units (PSUs); second, the sampling of households within the selected PSUs and finally, the random sampling of a household member.
Participants (n=1,100) will then take part in a 45-minute interview. This interview will be a household survey using the modular version of the Composite International Diagnostic Interview (WHO-CIDI) looking at exploring a broad spectrum of factors traditionally associated with increased risk of affective disorders:
- Sociodemographics
- Finance
- Variation in socioeconomic position
- Experience of victimization
- Discrimination
- Experience of childhood adversity
- Conditions
- Major Depressive Disorder
- Keywords
- prevalence, mood disorders, affective disorders, major depressive disorder, service use, migration health, global mental health
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Depressive Disorder
Assessed using the World Health Organisation Composite International Diagnostic Interview (WHO-CIDI)
Measured: baseline
Any affective/mood disorder
Assessed using the WHO-CIDI
Measured: baseline
Suicidal ideation, plans and attempts
Assessed using the WHO-CIDI
Measured: baseline
Depressive symptoms
Assessed using the nine-item Patient Health Questionnaire (PHQ-9).
The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe.
Measured: baseline
Anxiety symptoms
Assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7).
The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe.
Measured: baseline
Secondary outcomes (3)
Mental wellbeing
Assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
The 14 Items are scored on a range from 1 to 5, providing a total score between 14 and 70 with higher values indicating higher mental well-being.
Measured: baseline
Mental health service use
Assessed using items of the Services Module of the WHO-CIDI
Measured: baseline
Hazardous/harmful drinking
Assessed using the Alcohol Use Disorders Identification Test (AUDIT)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start29 Jul 2019
- Primary completion30 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, Antonia Errazuriz, Pontificia Universidad Catolica de Chile
- Investigators
- Antonia Errazuriz, PhD, Principal investigator, Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114565
- Sponsor's protocol ID
- 17051004
- Other IDs
- 96875479
- Acronym
- STRING
- Status last verified
- Jul 2020
- First submitted
- 30 Sep 2019
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (database, dictionary) will be made available to researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Santiago Immigrant Wellbeing Study (STRING): Prevalence of Mood Disorders Among Immigrants in Santiago, Chile
- ClinicalTrials.gov ID
- NCT04114565
- Acronym / sponsor ID
- STRING / 17051004
- Conditions
- Major Depressive Disorder
- Keywords
- prevalence, mood disorders, affective disorders, major depressive disorder, service use, migration health, global mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Oct 2019 (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 general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the Metropolitan Region of Santiago, Chile.
The hypotheses are:
- A healthy immigrant effect will be observed in the studied population by which their prevalence of major depressive disorder will be lower than the prevalence in the general Chilean population.
- A significant association will be observed between the loss of socio-economic position after migration and a greater probability of major depressive disorder.
- A significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of major depressive disorder.
- A significant association will be observed between financial difficulties and a greater probability of major depressive disorder.
The sampling framework of the Chilean National Institute of Statistics (INE) from the 2016 Census will be used for the purpose of this research. The sampling units are as follows:
- Primary sampling units (PSUs): conglomerates or groups of adjoining houses, organized in spatial blocks (200 households on average)
- Secondary sampling units (SSUs): individual households within each of the conglomerates selected in the first stage
- Final sampling units: persons meeting the study's inclusion criteria Multi-stage random probability sampling involving a 3-stage sampling design will be used - first, the sampling of the primary sampling units (PSUs); second, the sampling of households within the selected PSUs and finally, the random sampling of a household member.
Participants (n=1,100) will then take part in a 45-minute interview. This interview will be a household survey using the modular version of the Composite International Diagnostic Interview (WHO-CIDI) looking at exploring a broad spectrum of factors traditionally associated with increased risk of affective disorders:
- Sociodemographics
- Finance
- Variation in socioeconomic position
- Experience of victimization
- Discrimination
- Experience of childhood adversity
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults residing in private households in the Metropolitan Region of Santiago, Chile who were born outside of Chile and have lived in the country for at least 3 months
Key inclusion criteria (2 listed)
- Country of birth other than Chile
- Time since arrival to Chile: 3 months
Key exclusion criteria (1 listed)
- Unable to understand Spanish
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
Major Depressive Disorder
Time frame: baseline
Assessed using the World Health Organisation Composite International Diagnostic Interview (WHO-CIDI)
Any affective/mood disorder
Time frame: baseline
Assessed using the WHO-CIDI
Suicidal ideation, plans and attempts
Time frame: baseline
Assessed using the WHO-CIDI
Depressive symptoms
Time frame: baseline
Assessed using the nine-item Patient Health Questionnaire (PHQ-9). The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe.
Anxiety symptoms
Time frame: baseline
Assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe.
3 secondary outcomes
Mental wellbeing
Time frame: baseline
Mental health service use
Time frame: baseline
Hazardous/harmful drinking
Time frame: baseline
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 31 Jul 2020.
- ISRCTN registryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD (database, dictionary) will be made available to researchers upon request.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Antonia Errazuriz, PhD principal investigator
Universidad Catolica de Chile
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 Major Depressive Disorder, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 2 inclusion and 1 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 31 Jul 2020. 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 Chile. 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?
Major Depressive Disorder (time frame: baseline). The study lists 5 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 31 Jul 2020.