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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05748808
Study type Interventional
Source University of Seville
Contact Isabel M Gomez-Gonzalez, Phd
Phone +34954552787
Email igomez@us.es
Status Recruiting
Phase N/A
Start date December 1, 2023
Completion date September 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT00001233 - Study of Children at Risk for Disruptive Behavior Disorders N/A