Actively Recruiting

Phase Not Applicable
Age: 10Years - 16Years
All Genders
NCT05748808

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

Led by University of Seville · Updated on 2024-10-10

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Seville

Lead Sponsor

I

Instituto para el Estudio de la Biología de la Reproducción Humana

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Previous diagnosis of ADHD, Asperger syndrome, or oppositional defiant disorder (ODD) combined with lack of control over aggressiveness
  • Positive impulsivity score on specific tests: lower than 25 in CACIA, lower than 50 in CAPI-A, greater than 75 in Stroop, or greater than 115 in WCST
  • At least one aggressive outburst episode per week (verbal or physical aggression) during the two months before starting the study
Not Eligible

You will not qualify if you...

  • Current psychopharmacotherapy within the past month
  • History of bipolar disorder or psychotic disorder
  • Traumatic head injury with loss of consciousness longer than 60 minutes

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidad de Sevilla

Seville, Spain, 41012

Actively Recruiting

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Research Team

I

Isabel M Gomez-Gonzalez, Phd

CONTACT

A

Alberto J Molina-Cantero, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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