Internet-delivered Cognitive Behavioral Treatment of Depression and Anxiety in Latin American College Students

NCT ID: NCT04780542

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2025-06-30

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.

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.

Conditions

Major Depressive Disorder; Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinician-Guided iCBT

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

Group Type: EXPERIMENTAL

Yo Puedo Sentirme Bien- Clinician-Guided version

Intervention Type: BEHAVIORAL

Internet delivered Cognitive Behavioral Therapy- Guided version

Self-guided iCBT

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.

Group Type: ACTIVE_COMPARATOR

Yo Puedo Sentirme Bien- Self-Guided version

Intervention Type: BEHAVIORAL

Internet delivered Cognitive Behavioral Therapy- Self-Guided version

Interventions

Yo Puedo Sentirme Bien- Clinician-Guided version

Internet delivered Cognitive Behavioral Therapy- Guided version

Intervention Type: BEHAVIORAL

Yo Puedo Sentirme Bien- Self-Guided version

Internet delivered Cognitive Behavioral Therapy- Self-Guided version

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

OTHER

Sponsor Role: lead

Responsible Party

Corina Benjet

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corina Benjet, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Psiquiatría

Locations

Universidad Nacional de Colombia

Bogotá, , Colombia

Universidad Cooperativa de Colombia

Medellín, , Colombia

Fundación Universitaria del Area Andina

Valledupar, , Colombia

Universidad Popular de Cesar

Valledupar, , Colombia

Universidad Autonoma de Baja California

Ensenada, , Mexico

Universidad la Salle

León, , Mexico

Universidad Autonoma Metropolitana

Mexico City, , Mexico

Universidad Nacional Autonoma de México

Mexico City, , Mexico

Countries

Colombia; Mexico

References

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.

Reference Type: DERIVED

PMID: 40053727 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38032621 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37285133 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35658942 (View on PubMed)

Other Identifiers

R01MH120648-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EP20142

Identifier Type: -

Identifier Source: org_study_id