Image

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

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

Recruiting
10-16 years
All
Phase N/A

Powered by AI

Overview

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.

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

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.

Study details
    Passive-Aggressive Personality Disorder

NCT05748808

University of Seville

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.