Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Skin Temperature (ST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Skin Temperature (ST)
时间窗: 1 hour
The temperature of the skin. A minimum window length of 1 min guarantees a spectral resolution of 0.017 Hz at a sampling frequency of 13 Hz.
electrodermal activity (EDA)
时间窗: 1 hour
EDA is a measure of conductivity of human skin cause by the sweating, and can provide an indication of changes in human sympathetic nervous system (SNS). To process EDA data, we use Ledalab tools, configured with Continuous Decomposition Analysis (CDA) to recover the characteristics of the underlying signal of the sudomotor nerve; with Standard trough-to-peak (TTP), which analyzes maximums and minimums of the data window; and with Global that offers general values of the data. Recorded data are adapted to Ledalab input format by adding events in the time points when the experimenter introduces a tag. We shall use a two-second window with an overlap of 50% and a sensitivity of 1 μS.
Heart Rate Variability (HRV)
时间窗: 1 hour
The HRV is especially interesting because it allows as-sessing the activity of the parasympathetic and sympathetic pathways of the autonomic nervous system. We used a wearable placed in the chest with Ag/AgCl electrodes for ECG, placed following the Einthoven's II lead positions. The position of R wave is determined using an appropriate algorithm and then time difference between two consecutive R waves is calculated, this time difference is used to calculed HR. We used 30s-length sliding windows with an overlap of 50%. The instantaneous HR is given by the average HR in such a window after removing the outliers.
Breathing Rate (BR)
时间窗: 1 hour
Number of breaths a person takes per minute.
Electroencephalography (EEG)
时间窗: 1 hour
The EEG portrays the functioning of the brain. The recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. In this study it will be used the 16-channel configuration at a sampling rate of 125Hz and the following electrode placement: FP1, FP2, F1, F2, F5, F6, Cz, C3, C4, T7, T8, Pz, P3, P4, O1, O2 (Figure 5). Additional reference and ground electrodes will be placed on the right ear and Fpz positions respectively.
次要结局
未报告次要终点
研究者
Isabel Gómez González
Professor
University of Seville