Randomized Controlled Trials to Measure Neurophysiological Effects Using EEG Signals, Artificial Intelligence and Neuropsychological Techniques of a Mindfulness-Based Intervention in Young Adults with Symptoms of Anxiety and Depression
Trial ID: NCT06618339
Status: ENROLLING_BY_INVITATION
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-12-01
Completion date: 2025-10-01
Sponsor: Universidad Autonoma de Baja California
Conditions: Anxiety Depression (Mild or Not Persistent)
Interventions: Mindfulness-based intervention
Locations: Universidad Autónoma de Baja California, Neuroscience and Cognition Laboratory
Countries: Mexico
Enrollment: 125
Age range: 18 Years - 30 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* Young adults 18-30 years old
* University students enrolled in any of the Autonomous University of Baja California programs.
* To properly accomplish to all assessment procedures
* To properly accomplish at least 80% of the intervention sessions
* Interest to voluntarly participate.

Exclusion Criteria:

* Disgnosis of neurological or psychitric disease, including severe anxiety or depression.
* Incomplete protocol evaluation.
* Out of 18-30 years old range age.
* Being enrolled in a different psychological or psychiatric intervention or treatment program during the period of evaluation and intervention.

Outcomes:
Neurophysiological measures; Mood measures; Card Sorting Test; Self directed signaling; Stroop Test; Working memory; Gambling test; Tower of Hanoi; Metamemory; Neuropsychological evaluation; Neuropsychological measure