About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Members of the University of Seville community over 18 years old (students, teaching staff, and administration and service staff)
Be able to attend at least five of the six weeks of the Heart Rate Variability Biofeedback (HRV-BF) and Mindfulness (PEM) training programs
Have a smartphone.
Disqualifiers
Members of the University of Seville community who are experiencing severe anxiety or depression; a serious mental illness, such as hypomania or psychotic episodes; recent grief or a major loss; any heart disease; any other serious physical or mental health condition that may affect their ability to participate in the training program.
Trial design
Parallel
Treatments tested in this trial
Mindfulness Training Program
BehavioralThis mindfulness training program is based on the Mindfulness-Based Stress Reduction (MBSR) model developed by Jon Kabat-Zinn, incorporating elements of self-compassion and acceptance. What sets this program apart is its integration of both formal and informal practices. Participants engage in 45-minute guided sessions focused on breath awareness and the observation of thoughts, emotions, and physical sensations. Additionally, informal practices include brief daily moments of present-moment awareness. Participants will also receive 10 audio recordings for at-home practice, enhancing the program's accessibility and supporting consistency.
HRV Biofeedback
BehavioralThis HRV biofeedback training program is distinguished by its combination of advanced technology and a novel at-home methodology. Participants will engage in five weekly sessions, with four conducted at home using a heart rate sensor and the EliteHRV mobile app, which provides real-time feedback on heart rate variability. One session per week will take place in the lab, utilizing the Procomp Infiniti biofeedback system. The at-home approach is based on recent research (Schumann et al., 2021), offering participants a flexible yet structured method to practice biofeedback and improve heart rate variability over the six-week program.
Interoception Training
BehavioralThe interoception training program stands out by its focus on developing internal body awareness through structured guided sessions. Participants will engage in weekly 45-minute formal sessions at the university, where they will learn to focus on internal sensations like breath and muscle tension using specific techniques. Additionally, participants will receive 10 guided interoceptive exercises to practice at home, four times a week. This program not only focuses on the physical sensations but also integrates these practices into daily life, aiming to improve self-care and self-regulation over the six weeks, with personalized feedback provided.
Treatment groups
Trial outcomes
Primary outcomes
Perceived Stress
We measure stress using the Spanish Version (2.0) of the Perceived Stress Scale (PSS). Authors: Cohen S, Kamarck T, Mermelstein R. (1983); adapted by Eduardo Remor (2001). Validation data: Remor E, Carrobles JA. (2001). Spanish Version of the Perceived Stress Scale (PSS-14): Psychometric Study in an HIV+ Sample. Ansiedad y Estrés, 7 (2-3), 195-201. // Remor E. (2006). Psychometric Properties of a European Spanish Version of the Perceived Stress Scale (PSS). The Spanish Journal of Psychology, 9 (1), 86-93.
Heart Rate Variability (HRV) as a biomarker of Stress
HRV analysis in time domain \- SDNN (Standard Deviation of NN intervals): represents overall HRV and total autonomic activity. Units: ms.
Heart Rate Variability (HRV) as a biomarker of Stress
HRV analysis in time domain \- RMSSD (Root Mean Square of Successive Differences): reflects parasympathetic (vagal) activity. Units: ms
Heart Rate Variability (HRV) as a biomarker of Stress
HRV analysis in time domain \- NN50 / pNN50 (Number or percentage of consecutive NN intervals differing by \>50 ms): indicates short-term vagal regulation. Units: %
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