Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
NCT ID: NCT05748808
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-01
2025-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation
NCT04210648
Remote Mindfulness Training Following Early Life Adversity 2
NCT07085052
Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador
NCT06219642
Behavioral Management and Psychological Well-Being
NCT01823601
The Effects of Psycho-educational Training in Undergraduate Students at the University of Granada (Spain)
NCT05598944
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tweens and teens
Kids between 10 and 16. ADHD, Asperger or ODD, with lack of aggressiveness control.
Use of biofeedback and virtual reality in the treatment of aggressive outbursts
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.
Control group
children who will not receive the experimental treatment.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Use of biofeedback and virtual reality in the treatment of aggressive outbursts
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
10 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto para el Estudio de la Biología de la Reproducción Humana
UNKNOWN
University of Seville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Isabel Gómez González
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabel M Gomez-Gonzalez, Phd
Role: PRINCIPAL_INVESTIGATOR
University of Seville
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad de Sevilla
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
G. Alsina Masmitja, "Deficits de atencion y trastornos de conducta," Deficits de atencion y trastornos de conducta, pp. 1-259, 2014.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
A. Capafons and F. Silva, "Cuestionario de autocontrol infantil y adolescente (rev.)," Madrid: TEA, 2001
J. M. Andreu, "Cuestionario de agresividad premeditada e impulsiva en adolescentes," Madrid: Tea Ediciones, 2010
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.
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
T. Greitemeyer, "The spreading impact of playing violent video games on aggression," Computers in human behavior, vol. 80, pp. 216-219, 2018
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.
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.
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
W. Boucsein, Electrodermal Activity. Boston, MA: Springer US, 2012
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.
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.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BReTIA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.