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

Study acronym: BReTIA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 10, 2024 (before its estimated February 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Site details revisedv5
  2. Primary completion date: Feb 1, 2024 to Feb 1, 2025v4 Show 4 more changesShow less
    • Start date changed from estimate of Dec 1, 2023 to Sep 1, 2024
    • Study completion date: Sep 1, 2024 to Sep 1, 2025
    • Site details revised
    • Study arms: 1 to 2
  3. Start date: Jul 1, 2023 to Dec 1, 2023
    • Primary completion date: Sep 1, 2023 to Feb 1, 2024
    • Study completion date: Dec 1, 2023 to Sep 1, 2024
    v3
  4. Primary completion date: Mar 1, 2023 to Sep 1, 2023
    • Start date: Mar 1, 2023 to Jul 1, 2023
    • Study completion date: May 1, 2023 to Dec 1, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05748808
Lead Sponsor University of Seville
Collaborators: Instituto para el Estudio de la Biología de la Reproducción Humana
Conditions
(from sponsor)		 Passive-Aggressive Personality Disorder
Related terms Passive-Aggressive Personality Disorder
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov