Clinical trial NCT05748808: Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
Official title: Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Passive-Aggressive Personality Disorder
Keywords: Aggressive episodes
Emotional dysregulation
Physiological signals
Virtual reality
Biofeedback
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Instituto para el Estudio de la Biología de la Reproducción Humana
First posted: 2023-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: 1 hour
measure: electrodermal activity (EDA)
timeFrame: 1 hour
measure: Electroencephalography (EEG)
timeFrame: 1 hour
measure: Breathing Rate (BR)
timeFrame: 1 hour
measure: Skin Temperature (ST)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
affiliation: University of Seville
name: Isabel M Gomez-Gonzalez, Phd
role: PRINCIPAL_INVESTIGATOR
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