Using biofeedback and virtual reality to help manage aggressive outbursts
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
NA · University of Seville · NCT05748808
This study is testing whether using biofeedback and virtual reality can help people with aggressive outbursts learn to manage their emotions better and reduce their aggressive behavior.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 10 Years to 16 Years |
| Sex | All |
| Sponsor | University of Seville (other) |
| Locations | 1 site (Seville) |
| Trial ID | NCT05748808 on ClinicalTrials.gov |
What this trial studies
This study aims to treat aggressive episodes associated with conditions like Passive-Aggressive Personality Disorder by utilizing biofeedback and virtual reality (VR). Participants will have their physiological signals, such as heart rate and EEG, monitored during aggressive outbursts to help them recognize their internal states. Following these episodes, they will engage in VR sessions designed to promote relaxation and self-regulation. The intervention includes cognitive and behavioral therapies to teach participants positive coping skills and reduce the frequency of aggressive outbursts.
Who should consider this trial
Good fit: Ideal candidates are teenagers diagnosed with ADHD, Asperger syndrome, or oppositional defiant disorder who experience frequent aggressive outbursts.
Not a fit: Patients with a history of bipolar or psychotic disorders, or those currently undergoing psychopharmacotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency and intensity of aggressive outbursts in patients.
How similar studies have performed: While the combination of biofeedback and VR is innovative, similar studies have shown promise in using these technologies for emotional regulation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seville
- Universidad de Sevilla — Seville, Spain (RECRUITING)
Study contacts
- Principal investigator: Isabel M Gomez-Gonzalez, Phd — University of Seville
- Study coordinator: Isabel M Gomez-Gonzalez, Phd
- Email: igomez@us.es
- Phone: +34954552787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Passive-Aggressive Personality Disorder, Aggressive episodes, Emotional dysregulation, Physiological signals, Virtual reality, Biofeedback