Safety and preliminary efficacy of Aurora: a pilot, non-randomized clinical trial of a culturally adapted digital cognitive behavioral therapy intervention for anxiety and depression in Mexico.

Background/objective: Anxiety and depressive disorders are leading causes of disability worldwide, and access to evidence-based psychological treatment remains limited in many middle-income countries. Digital cognitive-behavioral therapy (CBT) interventions have emerged as scalable tools to address this treatment gap, yet few have undergone clinical evaluation in Latin American populations. This study aimed to assess the safety and preliminary efficacy of Aurora, a Spanish-language, culturally adapted digital CBT program, when used as an adjunct to pharmacotherapy in adults with generalized anxiety disorder. Methods: In a multicenter, open-label, non-randomized pilot study, 34 adults diagnosed with generalized anxiety disorder receiving stable pharmacological treatment were assigned through pragmatic, convenience-based allocation either to an experimental group (Aurora plus medication; n = 24) or to a control group receiving medication alone (n = 10). The sample had a mean age of 39.85 ± 12.88 years, with a predominance of women (22/34). Participants were followed for 12 weeks with assessments at baseline and weeks 4, 8, and 12. Clinical outcomes included anxiety severity measured by the Generalized Anxiety Disorder-7 (GAD-7), pathological worry assessed by the Penn State Worry Questionnaire (PSWQ), and depressive symptoms evaluated using the Patient Health Questionnaire-9 (PHQ-9). Safety was monitored through structured adverse-event reporting. Statistical analyses included linear mixed-effects models for longitudinal outcomes, ordinal logistic regression for severity transitions, and negative binomial regression and Fisher's exact test for adverse events, with false discovery rate correction applied where appropriate. Results: Aurora demonstrated a favorable safety profile, with no serious adverse events and comparable adverse-event incidence between groups under structured clinical monitoring at weeks 4, 8, and 12. Anxiety symptoms (GAD-7) showed a significant effect of time (F Conclusion: This pilot study provides preliminary, hypothesis-generating evidence that a culturally adapted digital CBT intervention can be safely integrated with pharmacotherapy and may be associated with enhanced improvements in anxiety-related outcomes, particularly pathological worry, in a Mexican clinical population. However, the non-randomized design, small sample size, and baseline imbalances limit causal inference and generalizability, and findings should be interpreted with caution. Larger randomized controlled trials are needed to confirm efficacy, determine long-term clinical impact, and guide the implementation of digital therapeutics in Latin American mental health systems.