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

NCT06695715 | Not Yet Recruiting

• 1 other identifier: SICEIA-2024-002431
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stress; Anxiety; Mindfulness; HRV Biofeedback; qEEG; University Students and Staff; Interoception

Outcome Measures

Primary Outcomes (13)

• 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.

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• 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.

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• 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

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• 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: %

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• Heart Rate Variability (HRV) as a biomarker of Stress

  HRV analysis in Frequency-Domain \- Total Power (0-0.4 Hz): Overall HRV across all frequency bands. Units: ms².

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• Heart Rate Variability (HRV) as a biomarker of Stress

  HRV analysis in Frequency-Domain \- HF (High Frequency, 0.15-0.4 Hz): Reflects parasympathetic activity (vagal tone). Units: ms²

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• Heart Rate Variability (HRV) as a biomarker of Stress

  HRV analysis in Frequency-Domain \- LF (Low Frequency, 0.04-0.15 Hz): Represents a mix of sympathetic and parasympathetic activity. Units: ms².

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• Heart Rate Variability (HRV) as a biomarker of Stress

  HRV analysis in Frequency-Domain LF/HF Ratio: Balance between sympathetic and parasympathetic activity. Units: ms².

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• QEEG as a biomarker of Stress. Frequency Bands and Power Analysis

  Delta Power (0.5-4 Hz).Units: Microvolts squared (µV²) or decibels (dB). Theta Power (4-8 Hz). Units: µV² or dB. Alpha Power (8-12 Hz). Units: µV² or dB. Beta Power (12-30 Hz). Units: µV² or dB. Gamma Power (\>30 Hz). Units: µV² or dB.

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• QEEG as a biomarker of Stress. Ratios as Indicators of Stress

  Theta/Beta Ratio: Evaluates emotional regulation and attentional processes. Stress relevance: High ratios often reflect underarousal or emotional stress, while low ratios suggest hyperarousal or anxiety. Alpha/Theta Ratio: Indicates balance between relaxation and alertness. Stress relevance: Lower ratios suggest stress or difficulty in maintaining relaxed alertness. Alpha/Beta Ratio: Reflects relaxation versus stress or anxiety levels. Stress relevance: Low ratios are associated with stress or hyperactivity.

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• QEEG as a biomarker of Stress. Coherence Measures

  Coherence (between regions): Measures synchronization between two brain areas. Units: Dimensionless (0-1). Stress relevance: High coherence may indicate rigid patterns (hyperconnectivity) due to stress, while low coherence may indicate disconnection or poor integration.

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• QEEG as a biomarker of Stress. Connectivity Measures

  Phase Lag Index (PLI): Quantifies the phase relationship between EEG signals, indicating functional connectivity. Units: Dimensionless (0-1). Stress relevance: Abnormal PLI values (too high or too low) may reflect stress-induced connectivity changes.

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

• QEEG as a biomarker of Stress. Asymmetry Measures

  Frontal Alpha Asymmetry: Compares alpha power between left and right frontal lobes (F3-F4). Units: Log-transformed ratios (e.g., log(left alpha) - log(right alpha)). Stress relevance: Greater right frontal alpha (reduced activity in the right hemisphere) is linked to negative affect or stress

  Baseline or pretraining (one week before training programs) and posttraining (one week after training programs; 7 weeks after first measure)

Study Arms (4)

Mindfulness

EXPERIMENTAL

The Mindfulness Training program will be based on the Mindfulness-Based Stress Reduction (MBSR) program and Jon Kabat-Zinn's Mindful Awareness practices, but will also include elements of self-compassion and acceptance. Intervention: During the six weeks of the program, participants will take part in a guided 45-minute formal session. Examples of formal guided meditations include mindfulness of breath and mindfulness of thoughts, feelings, and physiological sensations. Informal meditation practices will consist of brief pauses throughout the day, during which participants will voluntarily direct their attention to the present moment without judgment. Finally, participants will be provided with 10 audio recordings of guided meditations, recorded by a member of the research team, to support formal meditation at home (10-15 minutes four times a week), as well as a series of readings focused on the concepts of acceptance and self-compassion.

Behavioral: Mindfulness Training Program

HRV Biofeedback Training (HRV-BF)

EXPERIMENTAL

The HRV BF training will last for 6 weeks. There will be five training sessions per week, including four home sessions and one in-person session at the Neurociencia del Bienestar group laboratory (CTS-1129) at the Faculty of Psychology of the University of Seville. Each session will last 20 minutes. The laboratory session will be conducted using the Procomp Infiniti biofeedback equipment (Thought Technologies). For the home HRV-BF sessions, we will use a novel methodology recently described (Schumann et al., 2021). The heart rate will be recorded using a sensor embedded in a strap that will be worn around the participant's chest (H10/H7 heart rate sensor; Polar Electro Oy, Kempele, Finland). Via Bluetooth, the mobile app EliteHRV (Elite HRV LLC, 2017) will collect data from the sensor, store the recordings, and display the heart rate. The heart rate oscillations will be shown on the participants' smartphone screens as real-time visual feedback of their heart rate.

Behavioral: HRV Biofeedback

Interoceptive Training

EXPERIMENTAL

During the 6 weeks of the program, participants in this group will complete a 45-minute formal guided interoceptive training session at the Faculty of Psychology. During these sessions, the focus will be on developing internal body awareness through various strategies. Participants will learn to pay attention to internal sensations such as breathing and muscle tension using guided techniques. The program will include exercises to feel the flow of breath and relax specific areas of the body. The trainer will provide feedback and adjust techniques based on the participants' needs. Instructions will be given on how to integrate these practices into daily life to improve self-care and self-regulation. Finally, participants will be provided with 10 audio recordings of guided interoceptive exercises, recorded by a member of the research team, to support formal training at home (10-15 minutes, four times a week).

Behavioral: Interoception Training

Waiting list control group

NO INTERVENTION

Participants assigned to the waitlist control group will be key to ensuring the validity and reliability of the results of this project, allowing for precise and controlled comparisons of the effectiveness of the different training programs. These participants will also be evaluated at the beggining and the end, even though they will not participate in any training program. Once the program is completed, they will be offered the opportunity to participate in some of the training programs used in this project.

Interventions

Mindfulness Training Program BEHAVIORAL

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.

Mindfulness

HRV Biofeedback BEHAVIORAL

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.

HRV Biofeedback Training (HRV-BF)

Interoception Training BEHAVIORAL

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.

Interoceptive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Faculty Of Psychology. University of Seville

Seville, Seville, 41018, Spain

Location

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Francisco M Ocaña, PhD

  Wellness Neuroscience Group. University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco M Ocaña, PhD

CONTACT

+34 954 55 77 75; fmocana@us.es

Emilio Durán, PhD

CONTACT

+34 954554401; durang@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Associate Professor of Psychobiology. Principal Investigator of the Wellness Neuroscience Group-

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 19, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)