Clinical Trials to Evaluate Neurophysiological and Neuropsychological Effects of a Mindfulness-based Intervention

Depression and anxiety are conditions with a high prevalence in the world population and youth are no exception. In developing countries it is reported that given the conditions of social disadvantage, anxiety and depression are higher, resulting in compromised psychological well-being and mental health. Therefore, treatments that help in the care and prevention of these disorders from youth are important. In the case of contemporary psychology, Mindfulness treatments have emerged as an alternative treatment for some of the symptoms of depression, anxiety and emotional discomfort, showing evidence of increased improvement in the overall quality of life. The project responds to global mental health demands and will provide the institution, as well as external collaborating institutions and society in general, with guidelines to carry out brief and effective interventions for these problems and will develop clinical evidence and technological tools for their analysis. Objective: To compare the neurophysiological effects by means of EEG signals and machine learning or deep learning techniques and neuropsychological effects of a brief treatment based on mindfulness-based intervention techniques as an alternative intervention for the reduction of anxiety and depression symptoms against the effects of psychoeducation groups and placebo group in young adults. Methodology: Factorial design of cases and controls according to the guidelines for randomized controlled trials CONSORT. Participants (n=125) will be randomized triple-blinded with neuropsychological and neurophysiological assessments. The results of the project will generate basic evidence on the condition of brain functioning at the neurophysiological level, its performance to perform processes of utmost relevance to solve daily life problems and psychological well-being, as well as support the development of techniques for specialists in behavioral analysis and mental health and engineering sciences for the creation and implementation of programs and strategies for the prevention, identification, care and evaluation of mental health and social well-being, with a scientific and community health approach.

NCT Number	NCT06618339
Lead Sponsor	Universidad Autonoma de Baja California
Conditions	Anxiety Depression (Mild or Not Persistent)
Enrollment	125 participants
Start Date	2024-12-01
Primary Completion	2025-03-01 (estimated)
Study Completion	2025-10-01 (estimated)
Updated on ClinicalTrials.gov	2024-10-04