search
Back to results

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

Primary Purpose

Passive-Aggressive Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Use of biofeedback and virtual reality in the treatment of aggressive outbursts
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Passive-Aggressive Personality Disorder focused on measuring Aggressive episodes, Emotional dysregulation, Physiological signals, Virtual reality, Biofeedback

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de SevillaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tweens and teens

Arm Description

Kids between 10 and 16. ADHD, Asperger or ODD, with lack of aggressiveness control.

Outcomes

Primary Outcome Measures

Heart Rate Variability (HRV)
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.
electrodermal activity (EDA)
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.
Electroencephalography (EEG)
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.
Breathing Rate (BR)
Number of breaths a person takes per minute.
Skin Temperature (ST)
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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
May 11, 2023
Sponsor
University of Seville
Collaborators
Instituto para el Estudio de la Biología de la Reproducción Humana
search

1. Study Identification

Unique Protocol Identification Number
NCT05748808
Brief Title
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
Acronym
BReTIA
Official Title
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Instituto para el Estudio de la Biología de la Reproducción Humana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Passive-Aggressive Personality Disorder
Keywords
Aggressive episodes, Emotional dysregulation, Physiological signals, Virtual reality, Biofeedback

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tweens and teens
Arm Type
Experimental
Arm Description
Kids between 10 and 16. ADHD, Asperger or ODD, with lack of aggressiveness control.
Intervention Type
Behavioral
Intervention Name(s)
Use of biofeedback and virtual reality in the treatment of aggressive outbursts
Intervention Description
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 Outcome Measure Information:
Title
Heart Rate Variability (HRV)
Description
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.
Time Frame
1 hour
Title
electrodermal activity (EDA)
Description
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.
Time Frame
1 hour
Title
Electroencephalography (EEG)
Description
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.
Time Frame
1 hour
Title
Breathing Rate (BR)
Description
Number of breaths a person takes per minute.
Time Frame
1 hour
Title
Skin Temperature (ST)
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel M Gomez-Gonzalez, Phd
Phone
+34954552787
Email
igomez@us.es
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto J Molina-Cantero, PhD
Phone
+34954552787
Email
almolina@us.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel M Gomez-Gonzalez, Phd
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Sevilla
City
Sevilla
ZIP/Postal Code
41012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel M Gomez-Gonzalez, PhD
Phone
+34954552787
Email
igomez@us.es
First Name & Middle Initial & Last Name & Degree
Alberto J Molina-Cantero, PhD
Phone
+34954552787
Email
almolina@us.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
G. Alsina Masmitja, "Deficits de atencion y trastornos de conducta," Deficits de atencion y trastornos de conducta, pp. 1-259, 2014.
Results Reference
background
PubMed Identifier
25823741
Citation
Schonenberg M, Schneidt A, Wiedemann E, Jusyte A. Processing of Dynamic Affective Information in Adults With ADHD. J Atten Disord. 2019 Jan;23(1):32-39. doi: 10.1177/1087054715577992. Epub 2015 Mar 30.
Results Reference
background
PubMed Identifier
30710810
Citation
Fahlgren MK, Puhalla AA, Sorgi KM, McCloskey MS. Emotion processing in intermittent explosive disorder. Psychiatry Res. 2019 Mar;273:544-550. doi: 10.1016/j.psychres.2019.01.046. Epub 2019 Jan 14.
Results Reference
background
PubMed Identifier
33857522
Citation
Persico AM, Ricciardello A, Lamberti M, Turriziani L, Cucinotta F, Brogna C, Vitiello B, Arango C. The pediatric psychopharmacology of autism spectrum disorder: A systematic review - Part I: The past and the present. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Aug 30;110:110326. doi: 10.1016/j.pnpbp.2021.110326. Epub 2021 Apr 20.
Results Reference
background
Citation
B. M. Appelhans and L. J. Luecken, "Heart rate variability as an index of regulated emotional responding," Review of general psychology, vol. 10, no. 3, pp. 229-240, 2006.
Results Reference
background
PubMed Identifier
34682429
Citation
Costescu C, Sogor M, Thill S, Rosan A. Emotional Dysregulation in Preschoolers with Autism Spectrum Disorder-A Sample of Romanian Children. Int J Environ Res Public Health. 2021 Oct 12;18(20):10683. doi: 10.3390/ijerph182010683.
Results Reference
background
PubMed Identifier
27165346
Citation
Liddell BJ, Kemp AH, Steel Z, Nickerson A, Bryant RA, Tam N, Tay AK, Silove D. Heart rate variability and the relationship between trauma exposure age, and psychopathology in a post-conflict setting. BMC Psychiatry. 2016 May 10;16:133. doi: 10.1186/s12888-016-0850-5.
Results Reference
background
PubMed Identifier
32567956
Citation
Liao YC, Guo NW, Su BY, Chen SJ, Tsai HF, Lee KY. Frontal Beta Activity in the Meta-Intention of Children With Attention Deficit Hyperactivity Disorder. Clin EEG Neurosci. 2021 Mar;52(2):136-143. doi: 10.1177/1550059420933142. Epub 2020 Jun 22.
Results Reference
background
PubMed Identifier
30453757
Citation
Shereena EA, Gupta RK, Bennett CN, Sagar KJV, Rajeswaran J. EEG Neurofeedback Training in Children With Attention Deficit/Hyperactivity Disorder: A Cognitive and Behavioral Outcome Study. Clin EEG Neurosci. 2019 Jul;50(4):242-255. doi: 10.1177/1550059418813034. Epub 2018 Nov 20.
Results Reference
background
Citation
V. Delvigne, L. Ris, T. Dutoit, H. Wannous, and J.-P. Vandeborre, "Vera: Virtual environments recording attention," in 2020 IEEE 8th International Conference on Serious Games and Applications for Health (SeGAH). IEEE, 2020, pp. 1-7.
Results Reference
background
Citation
S. Adabla, L. Nabors, and K. Hamblin, "A scoping review of virtual real- ity interventions for youth with attention-deficit/hyperactivity disorder," Advances in Neurodevelopmental Disorders, vol. 5, no. 3, pp. 304-315, 2021.
Results Reference
background
PubMed Identifier
34248702
Citation
Karami B, Koushki R, Arabgol F, Rahmani M, Vahabie AH. Effectiveness of Virtual/Augmented Reality-Based Therapeutic Interventions on Individuals With Autism Spectrum Disorder: A Comprehensive Meta-Analysis. Front Psychiatry. 2021 Jun 23;12:665326. doi: 10.3389/fpsyt.2021.665326. eCollection 2021.
Results Reference
background
Citation
A. Capafons and F. Silva, "Cuestionario de autocontrol infantil y adolescente (rev.)," Madrid: TEA, 2001
Results Reference
background
Citation
J. M. Andreu, "Cuestionario de agresividad premeditada e impulsiva en adolescentes," Madrid: Tea Ediciones, 2010
Results Reference
background
PubMed Identifier
28446889
Citation
Scarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017.
Results Reference
background
Citation
R. K. Heaton, G. J. Chelune, J. L. Talley, G. G. Kay, and G. Curtiss, WCST: Test de clasificacion de tarjetas de Wisconsin. TEA Madrid, Spain:, 200
Results Reference
background
Citation
T. Greitemeyer, "The spreading impact of playing violent video games on aggression," Computers in human behavior, vol. 80, pp. 216-219, 2018
Results Reference
background
PubMed Identifier
12757141
Citation
Anderson CA, Carnagey NL, Eubanks J. Exposure to violent media: the effects of songs with violent lyrics on aggressive thoughts and feelings. J Pers Soc Psychol. 2003 May;84(5):960-71. doi: 10.1037/0022-3514.84.5.960.
Results Reference
background
Citation
L. Canet-Juric, A. Garcıa-Coni, M. L. Andres, S. Vernucci, Y. Ayd- mune, F. Stelzer et al., "Intervenci ́on sobre autorregulaci ́on cognitiva, conductual y emocional en ninos: Una revision de enfoques basados en procesos y en el currıculo escolar, en argentina," Revista Argentina de Ciencias del Comportamiento, vol. 12, no. 1, pp. 1-25, 2020.
Results Reference
background
Citation
J. A. Castro-Garcıa, A. J. Molina-Cantero, I. M. Gomez-Gonzalez, S. Lafuente-Arroyo, and M. Merino-Monge, "Towards human stress and activity recognition: A review and a first approach based on low-cost wearables," Electronics, vol. 11, no. 1, p. 155, 2022
Results Reference
background
Citation
W. Boucsein, Electrodermal Activity. Boston, MA: Springer US, 2012
Results Reference
background
PubMed Identifier
22680988
Citation
Boucsein W, Fowles DC, Grimnes S, Ben-Shakhar G, roth WT, Dawson ME, Filion DL; Society for Psychophysiological Research Ad Hoc Committee on Electrodermal Measures. Publication recommendations for electrodermal measurements. Psychophysiology. 2012 Aug;49(8):1017-34. doi: 10.1111/j.1469-8986.2012.01384.x. Epub 2012 Jun 8.
Results Reference
background
PubMed Identifier
4039264
Citation
Werner J, Heising M, Rautenberg W, Leimann K. Dynamics and topography of human temperature regulation in response to thermal and work load. Eur J Appl Physiol Occup Physiol. 1985;53(4):353-8. doi: 10.1007/BF00422853.
Results Reference
background
Citation
J. Werner, "Measurement of temperatures of the human body," Comprehensive Biomedical Physics, pp. 107-126, 2014. [Online]. Available: https://doi.org/10.1016/b978-0-444-53632-7.00515-3
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs