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NCT05748808: BReTIA

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

Recruiting now NA Last updated 10 October 2024
What this trial tests

NA trial testing Use of biofeedback and virtual reality in the treatment of aggressive outbursts in Passive-Aggressive Personality Disorder in 60 participants. Currently enrolling.

Timeline
1 September 2024
Primary endpoint
1 February 2025
1 September 2025

Quick facts

Lead sponsorUniversity of Seville
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment60
Start date1 September 2024
Primary completion1 February 2025
Estimated completion1 September 2025
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

University of Seville

Who can join

Adults 10 to 16, any sex, with Passive-Aggressive Personality Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University of Seville trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing