Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04780542 |
| Other study ID # |
EP20142 |
| Secondary ID |
R01MH120648-01A1 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
