NCT04780542

Brief 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.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
2 countries

8 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4.2 years

First QC Date

February 28, 2021

Last Update Submit

May 3, 2024

Conditions

Major Depressive DisorderGeneralized Anxiety Disorder

Keywords

iCBTLatin AmericaCollege StudentsDepressionAnxiety

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    12 months

Secondary Outcomes (2)

  • (Army STARRS) Role impairment

    90 days

  • (Army STARRS) Role impairment

    12 months

Study Arms (2)

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

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.

Behavioral: Yo Puedo Sentirme Bien- Self-Guided version

Interventions

Yo Puedo Sentirme Bien- Clinician-Guided versionBEHAVIORAL

Internet delivered Cognitive Behavioral Therapy- Guided version

Clinician-Guided iCBT
Yo Puedo Sentirme Bien- Self-Guided versionBEHAVIORAL

Internet delivered Cognitive Behavioral Therapy- Self-Guided version

Self-guided iCBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Screens positive for bipolar disorder, screens positive for psychosis, active suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Universidad Nacional de Colombia

Bogotá, Colombia

Location

Universidad Cooperativa de Colombia

Medellín, Colombia

Location

Fundación Universitaria del Area Andina

Valledupar, Colombia

Location

Universidad Popular de Cesar

Valledupar, Colombia

Location

Universidad Autonoma de Baja California

Ensenada, Mexico

Location

Universidad la Salle

León, Mexico

Location

Universidad Autonoma Metropolitana

Mexico City, Mexico

Location

Universidad Nacional Autonoma de México

Mexico City, Mexico

Location

Related Publications (4)

  • 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.

    PMID: 40053727DERIVED

  • Benjet 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.

    PMID: 38032621DERIVED

  • Benjet 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.

    PMID: 37285133DERIVED

  • Benjet 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.

    PMID: 35658942DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorGeneralized Anxiety DisorderDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Corina Benjet, PhD

    Instituto Nacional de Psiquiatría

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participant recruiters will be blinded to the participant's intended treatment arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2021

First Posted

March 3, 2021

Study Start

March 1, 2021

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will become available in Year 5, once trials are concluded
Access Criteria
By written request

Locations

CO(4)ME(4)