Clinical trial NCT04780542: Internet-delivered Cognitive Behavioral Treatment of Depression and Anxiety in Latin American College Students
Official title: Computerized Detection and Internet-based Treatment of Common Mental Disorders Among College Students in Two Latin American LMICs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Generalized Anxiety Disorder
Keywords: iCBT
Latin America
College Students
Depression
Anxiety
Lead sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Harvard Medical School (HMS and HSDM)
First posted: 2021-03-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 90 days
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 90 days
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 12 months
Secondary outcomes:
measure: (Army STARRS) Role impairment
timeFrame: 90 days
measure: (Army STARRS) Role impairment
timeFrame: 12 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
city: Medellín
country: Colombia
facility: Universidad Cooperativa de Colombia
city: Valledupar
country: Colombia
facility: Fundación Universitaria del Area Andina
city: Valledupar
country: Colombia
facility: Universidad Popular de Cesar
city: Ciudad de Mexico
country: Mexico
facility: Universidad Autonoma Metropolitana
city: Ensenada
country: Mexico
facility: Universidad Autonoma de Baja California
city: León
country: Mexico
facility: Universidad la Salle
city: Mexico City
country: Mexico
facility: Universidad Nacional Autonoma de México
Study officials:
affiliation: Instituto Nacional de Psiquiatría
name: Corina Benjet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.