Clinical Trial

Effects of HRV Biofeedback, Interoceptive Training, and Mindfulness on Stress in University Students and Staff

Study acronym: BIMStress
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Record status
This record was last updated November 19, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to learn if Heart Rate Variability Biofeedback (HRV-BF), Mindfulness programs, and Interoception training can reduce stress, improve well-being, and induce brain changes in university students and staff at the University of Seville. The main questions it aims to answer are: * Does HRV-BF training reduce stress, improve emotional regulation, and cause measurable brain changes in participants? * Does Mindfulness training reduce perceived stress, improve mental health, and lead to changes in brain activity? * Does Interoception training enhance emotional self-regulation, reduce stress, and produce changes in brain function? * How do the effects on the brain compare between the different types of training (HRV-BF, Mindfulness, and Interoception)? If there is a comparison group: Researchers will compare participants who receive HRV-BF, Mindfulness, and Interoception training to a waitlist control group to see if any of these interventions lead to greater reductions in stress, improvement in emotional regulation, or brain activity changes. Participants will: * Complete pre- and post-training assessments to measure stress levels, anxiety, emotional regulation, and brain activity using EEG (electroencephalography). * Participate in one of three interventions: HRV-BF training, where participants learn to use biofeedback to improve heart rate variability and manage stress. Mindfulness-based stress reduction, which involves meditation and mindful awareness techniques to reduce stress and improve mental health. Interoception training, where participants learn to focus on internal bodily signals (like heartbeat and breath) to improve emotional regulation and manage stress. Each intervention will last six weeks, and participants will be assessed at the beginning and end of the program. This study aims to determine which intervention is most effective at reducing stress, improving mental health, and producing beneficial changes in brain activity in university community members.
Trial Details
NCT Number NCT06695715
Lead Sponsor University of Seville
Conditions Stress, Anxiety
Enrollment 120 participants
Start Date 2025-01
Primary Completion 2025-07 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2024-11-19