Major Depressive DisorderNCT04780542
Internet-delivered Cognitive Behavioral Treatment of Depression and Anxiety in Latin American College Students
A study testing Yo Puedo Sentirme Bien- Clinician-Guided version and Yo Puedo Sentirme Bien- Self-Guided version in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 8 sites in 2 countries.
Trial summary
The aim is to evaluate short term and longer term treatment effects of internet-delivered cognitive behavioral therapy compared to treatment as usual for college students with anxiety and/or depression in low-middle income countries of Latin America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Generalized Anxiety Disorder
- What is being tested?
- Yo Puedo Sentirme Bien- Clinician-Guided version and Yo Puedo Sentirme Bien- Self-Guided version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Mar 2021to Jun 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age, screens positive for major depressive disorder and/or generalized anxiety disorder, student enrolled in one of the participating universities
Who cannot join
- Screens positive for bipolar disorder, screens positive for psychosis, active suicidality
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Colombia4 sites
Universidad Nacional de Colombia
Bogotá
Universidad Cooperativa de Colombia
Medellín
Fundación Universitaria del Area Andina
Valledupar
Universidad Popular de Cesar
Valledupar
Mexico4 sites
Universidad Autonoma de Baja California
Ensenada
Universidad la Salle
León
Universidad Autonoma Metropolitana
Mexico City
Universidad Nacional Autonoma de México
Mexico City
About this study
Official title: Computerized Detection and Internet-based Treatment of Common Mental Disorders Among College Students in Two Latin American LMICs
The aim is to evaluate short term and longer term treatment effects of internet-delivered cognitive behavioral therapy compared to treatment as usual for college students with anxiety and/or depression in low-middle income countries of Latin America.
Read the detailed description
This study is designed to detect, engage, and experimentally evaluate the effects of internet-based cognitive behavior therapy (e-CBT) to treat college students in two Latin American low-middle income countries (LMICs; Colombia and Mexico) with major depressive disorder and/or generalized anxiety disorder, with or without other comorbid common mental disorders (CMDs). Detection and engagement will be based on inexpensive internet-based recruitment and administration of self-report surveys. The intervention will be based on inexpensive e-CBT to address the low resources in LMICs. The study builds on prior research by collaborators in the WHO World Mental Health (WMH) survey consortium and WMH International College Study (WMH-ICS) initiative documenting high prevalence, impairment, and unmet need for treatment of CMDs among college students around the world and significant effects of e-CBT in treating these disorders in high income countries.
First, the investigators will carry out a pragmatic clinical trial with students seeking treatment for CMDs at student clinics in universities in Colombia and Mexico. Students on waitlists for student clinic services will be offered a possibility of receiving guided or self-guided e-CBT immediately while staying on the list. 33% of the students with CMD who express interest will be randomized to guided e-CBT, another 33% to self-guided e-CBT, and the remaining 33% to treatment as usual (TAU), where the latter is defined as remaining on the waiting list. Short-term aggregate intervention effects will be assessed 90 days after randomization and longer-term effects 12 months after randomization. The investigators will then use ensemble machine learning methods to predict heterogeneity of treatment effects of e-CBT versus TAU and develop a precision treatment rule (PTR) to predict which students will respond best to which intervention. A SMART design will then be implemented in which 50% of a second cohort of students from the same sample frame (i.e., students seeking treatment for CMDs at student clinics in the participating universities) will be randomized to the treatment arm predicted to be optimal by the PTR and the other 50% to randomization across arms. Based on the findings from the first pragmatic trial, none of the students were optimized by TAU. Therefore for the next cohort of students they will be randomized only to two arms, guided and unguided. Additionally, the investigators will use outreach to recruit students into the trial who might not otherwise seek treatment from student clinics. Two procedures will be used here. In the first, students will be recruited from annual WMH-ICS internet-based mental health needs assessment surveys that will be carried out with a probability sample of students to estimate unmet need for treatment and barriers to treatment. Students who respond to these surveys and meet inclusion criteria and are not in treatment will be randomized to guided e-CBT, self-guided e-CBT, and treatment as usual (only in first pragmatic trial) in student clinics to determine if access to guided and self-guided e-CBT reduces the unmet need for treatment among students with CMDs who fail to seek treatment at student health clinics. The second will expand recruitment by sending emails to random subsamples of students notifying them of the availability of the internet-based interventions and inviting them to participate in a trial. Students that respond to this announcement will then be recruited and randomized into the same three arms as among students that participated in the annual WMH-ICS survey.
- Being tested
- Yo Puedo Sentirme Bien- Clinician-Guided version, Yo Puedo Sentirme Bien- Self-Guided version
- Keywords
- iCBT, Latin America, College Students, Depression, Anxiety
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yo Puedo Sentirme Bien- Clinician-Guided versionBehavioural
Internet delivered Cognitive Behavioral Therapy- Guided version
Yo Puedo Sentirme Bien- Self-Guided versionBehavioural
Internet delivered Cognitive Behavioral Therapy- Self-Guided version
| Study group | Role | What they receive |
|---|---|---|
| Clinician-Guided iCBT | Experimental | Both help-seeking students recruited from university clinics and non-help-seeking students recruited from needs assessment survey and outreach will receive internet delivered cognitive behavioral therapy guided by clinicians Receives: Behavioral: Yo Puedo Sentirme Bien- Clinician-Guided version |
| Self-guided iCBT | Active comparator | Help-seeking students recruited from university clinics will receive self-guided internet delivered cognitive behavioral therapy while on waitlist. Non-help seeking students recruited from needs assessment survey and outreach will receive the self-guided version of internet delivered cognitive behavioral therapy. Receives: Behavioral: Yo Puedo Sentirme Bien- Self-Guided version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.
Measured: 90 days
Generalized Anxiety Disorder-7 (GAD-7)
Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.
Measured: 90 days
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.
Measured: 12 months
Generalized Anxiety Disorder-7 (GAD-7)
Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.
Measured: 12 months
Secondary outcomes (2)
(Army STARRS) Role impairment
Self-report measure of impairment due to mental health in four life areas in the prior 2 weeks. Scores in each area range from 0 to 10 with higher scores reflecting greater impairment.
Measured: 90 days
(Army STARRS) Role impairment
Self-report measure of impairment due to mental health in four life areas in the prior 2 weeks. Scores in each area range from 0 to 10 with higher scores reflecting greater impairment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Mar 2021
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Corina Benjet, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Investigators
- Corina Benjet, PhD, Principal investigator, Instituto Nacional de Psiquiatría
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780542
- Sponsor's protocol ID
- EP20142
- Other IDs
- R01MH120648-01A1
- Status last verified
- May 2024
- First submitted
- 28 Feb 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: First, we will document and make available all imputations, weights, and constructed variables used in our analyses. Second, we will host a project webinars to present an overview of the data and answer questions. The webinars will be widely advertised in list serves, including any such sites recommended by NIMH, as well as to NIH training programs. An English version of the webinars will be hosted by the US collaborators. A Spanish version will be hosted by the Mexican collaborators. Third, we will set up and man a project Q\&A web site in which public users can ask questions and get answers about issues involved in working with the data. Again, the site will be both in English and Spanish. Fourth, we will gather up written versions of all questions asked by public users along with our written response (including any documentation or computer files sent along with these answers) and post these on the website in both English and Spanish as reference documents for future public users.
Publications
Benjet C, Zainal NH, Albor Y, Alvis-Barranco L, Carrasco Tapia N, Contreras-Ibanez CC, Cortes-Morelos J, Cudris-Torres L, de la Pena FR, Gonzalez N, Gutierrez-Garcia RA, Vargas-Contreras E, Medina-Mora ME, Patino P, Gildea SM, Kennedy CJ, Luedtke A, Sampson NA, Petukhova MV, Zubizarreta JR, Cuijpers P, Kazdin AE, Kessler RC. The Effect of Predicted Compliance With a Web-Based Intervention for Anxiety and Depression Among Latin American University Students: Randomized Controlled Trial. JMIR Ment Health. 2025 Feb 28;12:e64251. doi: 10.2196/64251.
PubMed 40053727Benjet C, Albor Y, Alvis-Barranco L, Contreras-Ibanez CC, Cuartas G, Cudris-Torres L, Gonzalez N, Cortes-Morelos J, Gutierrez-Garcia RA, Medina-Mora ME, Patino P, Vargas-Contreras E, Cuijpers P, Gildea SM, Kazdin AE, Kennedy CJ, Luedtke A, Sampson NA, Petukhova MV, Zainal NH, Kessler RC. Internet-delivered cognitive behavior therapy versus treatment as usual for anxiety and depression among Latin American university students: A randomized clinical trial. J Consult Clin Psychol. 2023 Dec;91(12):694-707. doi: 10.1037/ccp0000846.
PubMed 38032621Benjet C, Zainal NH, Albor Y, Alvis-Barranco L, Carrasco-Tapias N, Contreras-Ibanez CC, Cudris-Torres L, de la Pena FR, Gonzalez N, Guerrero-Lopez JB, Gutierrez-Garcia RA, Jimenez-Perez AL, Medina-Mora ME, Patino P, Cuijpers P, Gildea SM, Kazdin AE, Kennedy CJ, Luedtke A, Sampson NA, Petukhova MV, Kessler RC. A Precision Treatment Model for Internet-Delivered Cognitive Behavioral Therapy for Anxiety and Depression Among University Students: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2023 Aug 1;80(8):768-777. doi: 10.1001/jamapsychiatry.2023.1675.
PubMed 37285133Benjet C, Kessler RC, Kazdin AE, Cuijpers P, Albor Y, Carrasco Tapias N, Contreras-Ibanez CC, Duran Gonzalez MS, Gildea SM, Gonzalez N, Guerrero Lopez JB, Luedtke A, Medina-Mora ME, Palacios J, Richards D, Salamanca-Sanabria A, Sampson NA. Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study. Trials. 2022 Jun 2;23(1):450. doi: 10.1186/s13063-022-06255-3.
PubMed 35658942
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Detection and Internet-based Treatment of Common Mental Disorders Among College Students in Two Latin American LMICs
- ClinicalTrials.gov ID
- NCT04780542
- Acronym / sponsor ID
- EP20142
- Keywords
- iCBT, Latin America, College Students, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard Medical School (HMS and HSDM)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 3 Mar 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 aim is to evaluate short term and longer term treatment effects of internet-delivered cognitive behavioral therapy compared to treatment as usual for college students with anxiety and/or depression in low-middle income countries of Latin America.
Detailed description
This study is designed to detect, engage, and experimentally evaluate the effects of internet-based cognitive behavior therapy (e-CBT) to treat college students in two Latin American low-middle income countries (LMICs; Colombia and Mexico) with major depressive disorder and/or generalized anxiety disorder, with or without other comorbid common mental disorders (CMDs). Detection and engagement will be based on inexpensive internet-based recruitment and administration of self-report surveys. The intervention will be based on inexpensive e-CBT to address the low resources in LMICs. The study builds on prior research by collaborators in the WHO World Mental Health (WMH) survey consortium and WMH International College Study (WMH-ICS) initiative documenting high prevalence, impairment, and unmet need for treatment of CMDs among college students around the world and significant effects of e-CBT in treating these disorders in high income countries.
First, the investigators will carry out a pragmatic clinical trial with students seeking treatment for CMDs at student clinics in universities in Colombia and Mexico. Students on waitlists for student clinic services will be offered a possibility of receiving guided or self-guided e-CBT immediately while staying on the list. 33% of the students with CMD who express interest will be randomized to guided e-CBT, another 33% to self-guided e-CBT, and the remaining 33% to treatment as usual (TAU), where the latter is defined as remaining on the waiting list. Short-term aggregate intervention effects will be assessed 90 days after randomization and longer-term effects 12 months after randomization. The investigators will then use ensemble machine learning methods to predict heterogeneity of treatment effects of e-CBT versus TAU and develop a precision treatment rule (PTR) to predict which students will respond best to which intervention. A SMART design will then be implemented in which 50% of a second cohort of students from the same sample frame (i.e., students seeking treatment for CMDs at student clinics in the participating universities) will be randomized to the treatment arm predicted to be optimal by the PTR and the other 50% to randomization across arms. Based on the findings from the first pragmatic trial, none of the students were optimized by TAU. Therefore for the next cohort of students they will be randomized only to two arms, guided and unguided. Additionally, the investigators will use outreach to recruit students into the trial who might not otherwise seek treatment from student clinics. Two procedures will be used here. In the first, students will be recruited from annual WMH-ICS internet-based mental health needs assessment surveys that will be carried out with a probability sample of students to estimate unmet need for treatment and barriers to treatment. Students who respond to these surveys and meet inclusion criteria and are not in treatment will be randomized to guided e-CBT, self-guided e-CBT, and treatment as usual (only in first pragmatic trial) in student clinics to determine if access to guided and self-guided e-CBT reduces the unmet need for treatment among students with CMDs who fail to seek treatment at student health clinics. The second will expand recruitment by sending emails to random subsamples of students notifying them of the availability of the internet-based interventions and inviting them to participate in a trial. Students that respond to this announcement will then be recruited and randomized into the same three arms as among students that participated in the annual WMH-ICS survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician-Guided iCBT | Experimental | Behavioral: Yo Puedo Sentirme Bien- Clinician-Guided versionBoth help-seeking students recruited from university clinics and non-help-seeking students recruited from needs assessment survey and outreach will receive internet delivered cognitive behavioral therapy guided by clinicians |
| Self-guided iCBT | Active comparator | Behavioral: Yo Puedo Sentirme Bien- Self-Guided versionHelp-seeking students recruited from university clinics will receive self-guided internet delivered cognitive behavioral therapy while on waitlist. Non-help seeking students recruited from needs assessment survey and outreach will receive the self-guided version of internet delivered cognitive behavioral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years of age, screens positive for major depressive disorder and/or generalized anxiety disorder, student enrolled in one of the participating universities
Key exclusion criteria (1 listed)
- Screens positive for bipolar disorder, screens positive for psychosis, active suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yo Puedo Sentirme Bien- Clinician-Guided versionInternet delivered Cognitive Behavioral Therapy- Guided version | Behavioural | Clinician-Guided iCBT |
| Yo Puedo Sentirme Bien- Self-Guided versionInternet delivered Cognitive Behavioral Therapy- Self-Guided version | Behavioural | Self-guided iCBT |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 90 days
Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 90 days
Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months
Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 12 months
Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.
2 secondary outcomes
(Army STARRS) Role impairment
Time frame: 90 days
(Army STARRS) Role impairment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 40053727Benjet C, Zainal NH, Albor Y, Alvis-Barranco L, Carrasco Tapia N, Contreras-Ibanez CC, Cortes-Morelos J, Cudris-Torres L, de la Pena FR, Gonzalez N, Gutierrez-Garcia RA, Vargas-Contreras E, Medina-Mora ME, Patino P, Gildea SM, Kennedy CJ, Luedtke A, Sampson NA, Petukhova MV, Zubizarreta JR, Cuijpers P, Kazdin AE, Kessler RC. The Effect of Predicted Compliance With a Web-Based Intervention for Anxiety and Depression Among Latin American University Students: Randomized Controlled Trial. JMIR Ment Health. 2025 Feb 28;12:e64251. doi: 10.2196/64251.
- Derived from this study: PubMed 38032621Benjet C, Albor Y, Alvis-Barranco L, Contreras-Ibanez CC, Cuartas G, Cudris-Torres L, Gonzalez N, Cortes-Morelos J, Gutierrez-Garcia RA, Medina-Mora ME, Patino P, Vargas-Contreras E, Cuijpers P, Gildea SM, Kazdin AE, Kennedy CJ, Luedtke A, Sampson NA, Petukhova MV, Zainal NH, Kessler RC. Internet-delivered cognitive behavior therapy versus treatment as usual for anxiety and depression among Latin American university students: A randomized clinical trial. J Consult Clin Psychol. 2023 Dec;91(12):694-707. doi: 10.1037/ccp0000846.
- Derived from this study: PubMed 37285133Benjet C, Zainal NH, Albor Y, Alvis-Barranco L, Carrasco-Tapias N, Contreras-Ibanez CC, Cudris-Torres L, de la Pena FR, Gonzalez N, Guerrero-Lopez JB, Gutierrez-Garcia RA, Jimenez-Perez AL, Medina-Mora ME, Patino P, Cuijpers P, Gildea SM, Kazdin AE, Kennedy CJ, Luedtke A, Sampson NA, Petukhova MV, Kessler RC. A Precision Treatment Model for Internet-Delivered Cognitive Behavioral Therapy for Anxiety and Depression Among University Students: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2023 Aug 1;80(8):768-777. doi: 10.1001/jamapsychiatry.2023.1675.
- Derived from this study: PubMed 35658942Benjet C, Kessler RC, Kazdin AE, Cuijpers P, Albor Y, Carrasco Tapias N, Contreras-Ibanez CC, Duran Gonzalez MS, Gildea SM, Gonzalez N, Guerrero Lopez JB, Luedtke A, Medina-Mora ME, Palacios J, Richards D, Salamanca-Sanabria A, Sampson NA. Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study. Trials. 2022 Jun 2;23(1):450. doi: 10.1186/s13063-022-06255-3.
- Individual participant dataSharing planned: Yes. First, we will document and make available all imputations, weights, and constructed variables used in our analyses. Second, we will host a project webinars to present an overview of the data and answer questions. The webinars will be widely advertised in list serves, including any such sites recommended by NIMH, as well as to NIH training programs. An English version of the webinars will be hosted by the US collaborators. A Spanish version will be hosted by the Mexican collaborators. Third, we will set up and man a project Q\&A web site in which public users can ask questions and get answers about issues involved in working with the data. Again, the site will be both in English and Spanish. Fourth, we will gather up written versions of all questions asked by public users along with our written response (including any documentation or computer files sent along with these answers) and post these on the website in both English and Spanish as reference documents for future public users.
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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.
Corina Benjet, PhD principal investigator
Instituto Nacional de Psiquiatría
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yo Puedo Sentirme Bien- Clinician-Guided version and Yo Puedo Sentirme Bien- Self-Guided version in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 8 sites in 2 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Colombia, 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?
Results are not available in the source record.
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: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04780542, which also lists 4 linked publications.
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 7 May 2024.