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NCT Number: NCT05748808

Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts

The methodology will be applied for the treatment of aggressive episodes. Many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder (ASD). It will be studied the effect of aggressive outbursts on several physiological signals (heart rate (HR), breathing rate (BR), electroencephalography (EEG), etc). The use of those signals in a biofeedback loop could help patients recognize their internal states and avoid imminent aggression. The study want to verify the efficacy of a cognitive therapy that includes biofeedback and virtual reality (VR) and find out the most significant physiological features that are affected by these episodes.

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Key information

Conditions

Passive-Aggressive Personality Disorder Mental Disorders Personality Disorders

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The first goal is to register the scene together with physiological values before, during and after at least up to four aggressive outbursts at home.

Next an outburst is induced and physiological signals before, during and after the aggressive episode are recorded. After it the participants go to a new relaxation phase for another 10-minute period using the VR.

In following sessions, they are trained to identify their physiological response when they are relaxed and when an outburst is coming. To do that, the VR system receives and shows the physiological information on the virtual scenario.

In following sessions, teenagers are then treated with cognitive, behavioral and emotional self-regulation therapies, which have proven their effectiveness for managing anger and learning positive coping skills. The underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds, by focusing on them continuously.

At the end of the experiment, the number of aggressive episodes in the last weeks of the intervention will be measured.

The differences between the new scores, with respect to the initial ones, will be used to assess the efficacy of the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous diagnosis of ADHD, Asperger syndrome or oppositional defiant disorder (ODD) combined with a lack of control of their aggressiveness.
  • Positive impulsivity result obtained with any of the fol- lowing tests: score lower than 25 in CACIA [13], lower than 50 in CAPI-A [14], greater than 75 in Stroop [15] or greater than 115 in WCST [16].
  • Intermittent outburst episodes (verbal aggression includ- ing both arguments and temper tantrums, and physical aggression towards self or others) with a frequency of once a week in the two months prior to the beginning of the intervention.

Exclusion criteria

  • Participants will be excluded if they report (a) current (past month) psychopharmacotherapy, (b) a history of bipolar or psychotic disorder, or (c) a traumatic head injury with a loss of consciousness in excess of 60 minutes.

Treatment and study plan

Use of biofeedback and virtual reality in the treatment of aggressive outbursts

Behavioral

Participants are trained to identify their physiological response when they are relaxed and when an outburst is coming. They are treated with cognitive, behavioral and emotional self-regulation therapies for managing anger and learning positive coping skills. Biofeedback toghether with virtual reality help them to improve their recognition and control of emotions.

Primary outcomes

  1. Heart Rate Variability (HRV)

    Time frame: 1 hour

    The HRV is especially interesting because it allows as-sessing the activity of the parasympathetic and sympathetic pathways of the autonomic nervous system. We used a wearable placed in the chest with Ag/AgCl electrodes for ECG, placed following the Einthoven's II lead positions. The position of R wave is determined using an appropriate algorithm and then time difference between two consecutive R waves is calculated, this time difference is used to calculed HR.

    We used 30s-length sliding windows with an overlap of 50%. The instantaneous HR is given by the average HR in such a window after removing the outliers.

  2. electrodermal activity (EDA)

    Time frame: 1 hour

    EDA is a measure of conductivity of human skin cause by the sweating, and can provide an indication of changes in human sympathetic nervous system (SNS). To process EDA data, we use Ledalab tools, configured with Continuous Decomposition Analysis (CDA) to recover the characteristics of the underlying signal of the sudomotor nerve; with Standard trough-to-peak (TTP), which analyzes maximums and minimums of the data window; and with Global that offers general values of the data. Recorded data are adapted to Ledalab input format by adding events in the time points when the experimenter introduces a tag. We shall use a two-second window with an overlap of 50% and a sensitivity of 1 μS.

  3. Electroencephalography (EEG)

    Time frame: 1 hour

    The EEG portrays the functioning of the brain. The recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. In this study it will be used the 16-channel configuration at a sampling rate of 125Hz and the following electrode placement: FP1, FP2, F1, F2, F5, F6, Cz, C3, C4, T7, T8, Pz, P3, P4, O1, O2 (Figure 5). Additional reference and ground electrodes will be placed on the right ear and Fpz positions respectively.

  4. Breathing Rate (BR)

    Time frame: 1 hour

    Number of breaths a person takes per minute.

  5. Skin Temperature (ST)

    Time frame: 1 hour

    The temperature of the skin. A minimum window length of 1 min guarantees a spectral resolution of 0.017 Hz at a sampling frequency of 13 Hz.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto J Molina-Cantero, PhD

CONTACT

[email protected]

+34954552787

Isabel M Gomez-Gonzalez, Phd

CONTACT

[email protected]

+34954552787

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Instituto para el Estudio de la Biología de la Reproducción Humana

Registry information

Acronym: BReTIA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2023
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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