Effects of HRV Biofeedback, Interoceptive Training, and Mindfulness on Stress in University Students and Staff
NCT06695715 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-11-19
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.
Conditions
- Stress
- Anxiety
Interventions
- BEHAVIORAL
-
Mindfulness Training Program
This 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.
- BEHAVIORAL
-
HRV Biofeedback
This 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.
- BEHAVIORAL
-
Interoception Training
The 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.
Sponsors & Collaborators
-
University of Seville
lead OTHER
Principal Investigators
-
Francisco M Ocaña, PhD · Wellness Neuroscience Group. University of Seville
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-31
- Primary Completion
- 2025-07-31
- Completion
- 2026-02-28
Countries
- Spain
Study Locations
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