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

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.govNCT04780542. First submission date: February 28, 2021.

Internet-delivered cognitive behavior therapy versus treatment as usual for anxiety and depression among Latin American university students: A randomized clinical trial.

“…Consistent with previous research (Cuijpers et al, 2019; J. H. Wright et al, 2019), our preregistered hypothesis (Benjet et al, 2022) was that participants randomized to guided i-CBT would have significantly better aggregate outcomes than those randomized to self-guided i-CBT. This has been found not only for remission but also for symptoms of clinical depression (Berger et al, 2011; Cuijpers et al, 2019) and anxiety disorders (Ciuca et al, 2018; Oliveira et al, 2023).…”

“…As discussed in more detail elsewhere (Luedtke et al, 2019) and in our preregistered protocol (Benjet et al, 2022; https://ClinicalTrials .gov, Identifier NCT04780542), we used simulation to estimate the required sample size for 0.8 power to detect heterogeneity of treatment effects (the ultimate focus of this research) that would result in a 5% higher aggregate remission rate if all participants were optimized across interventions rather than randomized across interventions. This required sample size was approximately 500 participants per intervention arm initiating treatment based on an assumption of mildly informative loss to follow-up comparable in magnitude to the loss rates found in previous i-CBT trials (Torous et al, 2020).…”

A Precision Treatment Model for Internet-Delivered Cognitive Behavioral Therapy for Anxiety and Depression Among University Students

“…Initial follow-up SAQ nonrespondents were sent email reminders, WhatsApp or Telegram messages, and telephone calls to minimize loss to follow-up (eMethods in Supplement 2). More details on the study design are reported elsewhere . Initial data analysis for the present report was conducted from May 23 to October 26, 2022.…”

Personalización en Psicoterapia: Estado Actual y Desafíos para su Implementación en Latinoamérica

“…El primero de ellos, el estudio "Yo puedo sentirme bien" (Benjet et al, 2022), busca evaluar los efectos de un tratamiento transdiagnóstico Cognitivo Conductual realizado a través de Internet (iCBT, por su sigla en inglés) para tratar Trastorno de Depresión Mayor y cia y a la cultura afectan el avance en la personalización de tratamientos psicoterapéuticos. A continuación, se mencionarán dos grandes áreas que se vinculan y retroalimentan entre sí, generando obstáculos o desafíos a la hora de implementar estrategias para personalizar tratamientos.…”