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

Corina Benjet, Ronald C Kessler, Alan E Kazdin, Pim Cuijpers, Yesica Albor, Nayib Carrasco Tapias, Carlos C Contreras-Ibáñez, Ma Socorro Durán González, Sarah M Gildea, Noé González, José Benjamín Guerrero López, Alex Luedtke, Maria Elena Medina-Mora, Jorge Palacios, Derek Richards, Alicia Salamanca-Sanabria, Nancy A Sampson, Corina Benjet, Ronald C Kessler, Alan E Kazdin, Pim Cuijpers, Yesica Albor, Nayib Carrasco Tapias, Carlos C Contreras-Ibáñez, Ma Socorro Durán González, Sarah M Gildea, Noé González, José Benjamín Guerrero López, Alex Luedtke, Maria Elena Medina-Mora, Jorge Palacios, Derek Richards, Alicia Salamanca-Sanabria, Nancy A Sampson

Abstract

Background: Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are highly prevalent among university students and predict impaired college performance and later life role functioning. Yet most students do not receive treatment, especially in low-middle-income countries (LMICs). We aim to evaluate the effects of expanding treatment using scalable and inexpensive Internet-delivered transdiagnostic cognitive behavioral therapy (iCBT) among college students with symptoms of MDD and/or GAD in two LMICs in Latin America (Colombia and Mexico) and to investigate the feasibility of creating a precision treatment rule (PTR) to predict for whom iCBT is most effective.

Methods: We will first carry out a multi-site randomized pragmatic clinical trial (N = 1500) of students seeking treatment at student mental health clinics in participating universities or responding to an email offering services. Students on wait lists for clinic services will be randomized to unguided iCBT (33%), guided iCBT (33%), and treatment as usual (TAU) (33%). iCBT will be provided immediately whereas TAU will be whenever a clinic appointment is available. Short-term aggregate effects will be assessed at 90 days and longer-term effects 12 months after randomization. We will use ensemble machine learning to predict heterogeneity of treatment effects of unguided versus guided iCBT versus TAU and develop a precision treatment rule (PTR) to optimize individual student outcome. We will then conduct a second and third trial with separate samples (n = 500 per arm), but with unequal allocation across two arms: 25% will be assigned to the treatment determined to yield optimal outcomes based on the PTR developed in the first trial (PTR for optimal short-term outcomes for Trial 2 and 12-month outcomes for Trial 3), whereas the remaining 75% will be assigned with equal allocation across all three treatment arms.

Discussion: By collecting comprehensive baseline characteristics to evaluate heterogeneity of treatment effects, we will provide valuable and innovative information to optimize treatment effects and guide university mental health treatment planning. Such an effort could have enormous public-health implications for the region by increasing the reach of treatment, decreasing unmet need and clinic wait times, and serving as a model of evidence-based intervention planning and implementation.

Trial status: IRB Approval of Protocol Version 1.0; June 3, 2020. Recruitment began on March 1, 2021. Recruitment is tentatively scheduled to be completed on May 30, 2024.

Trial registration: ClinicalTrials.gov NCT04780542 . First submission date: February 28, 2021.

Keywords: Anxiety; College students; Depression; Latin America; Precision treatment algorithm; iCBT.

Conflict of interest statement

In the past 3 years, Dr. Kessler was a consultant for Datastat, Inc.; Holmusk; RallyPoint Networks, Inc.; and Sage Therapeutics He has stock options in Mirah, PYM, and Roga Sciences. None of the other authors report conflicts of interest. Alex Luedtke received funds as a statistical consultant for Ronald Kessler at Harvard Medical School. Derek Richards and Jorge Palacios are employees of SilverCloud Health, developers of computerized psychological interventions. Since 2021, SilverCloud health is a subsidiary of Amwell. Derek Richards is a minority shareholder in Amwell.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Participant timeline
Fig. 2
Fig. 2
Schedule of enrollment, intervention, and assessments for pragmatic trials 1, 2, and 3

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Source: PubMed

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