Acceptability and feasibility of a universal online preventive intervention for depression and anxiety among university students: protocol of a pilot randomized controlled trial.

Abstract

<title>Abstract</title> <bold>Background</bold>. The mental health of university students is a global concern, with high rates of depression, anxiety, and stress significantly impacting their well-being and academic performance. Several studies reveal high prevalence rates, highlighting the need for effective prevention strategies. Evidence shows that digital interventions incorporating mindfulness, emotional regulation, and cognitive-behavioral techniques can reduce symptoms of mental illness. However, such programs are scarce in Latin America. This study proposes developing and evaluating "CUIDATE," a brief online universal preventive intervention targeting depression and anxiety among university students, focusing on acceptability, feasibility, and potential improvements in mental health and quality of life. <bold>Methods:</bold>This is a pilot randomized controlled trial, parallel-group type, where students using CUIDATE, a 6-session online self-guided universal preventive intervention, are compared to students doing regular academic work. 50 students in a private university in Santiago, Chile, are expected to be recruited and randomized with 1:1 allocation. Assessments of acceptability and feasibility during the whole project will be collected at the end of the intervention. Measurements of depression and anxiety symptoms, quality of life, and several mindfulness, emotional regulation, and cognitive-behavioral skills will be conducted among students of both groups at baseline, post-intervention and 12-week follow-up. <bold>Discussion. </bold>This pilot Randomized Controlled Trial aims to evaluate the acceptability and feasibility of "CUIDATE," a self-guided online intervention promoting cognitive-behavioral therapy skills, emotion regulation, and a healthy lifestyle to prevent depression and anxiety. Unlike existing programs, often limited to developed countries, CUIDATE is designed for accessibility and cost-effectiveness, using the widely adopted Canvas platform to engage university students. While challenges like recruitment and task adherence are anticipated, proactive measures, including student leaders’ network support, will mitigate these risks. The study's findings will produce relevant information about these novel designs and may help guide future studies, such as a randomized controlled trial on a large scale. <bold>Trial registration:</bold> Clinical Trials NCT06419868, May 14. 2024 [https://www.clinicaltrials.gov/study/NCT06419868]