Key result
This study protocol outlines a planned randomized controlled trial to evaluate the effectiveness of integrating biofeedback into therapy for aggressive outbursts in 70 children and adolescents.
Why the study?
Aggressive episodes involve autonomic arousal before aggression manifests, and whether incorporating biofeedback can enhance emotional regulation and reduce aggression in children and adolescents requires evaluation.
Does therapy incorporating biofeedback improve emotional regulation and reduce aggressive episodes in children and adolescents compared to therapy alone?
RCT (n=70)
Randomized
Does therapy incorporating biofeedback improve emotional regulation and reduce aggressive episodes in children and adolescents compared to therapy alone?
This study protocol outlines a randomized controlled trial to evaluate whether integrating biofeedback into therapy improves emotional regulation and reduces aggressive episodes in children and adolescents.
Leaves open biofeedback efficacy for youth aggression; RCT protocol now underway to test integration.
INTRODUCTION: This study provides a comprehensive overview of the materials and methods used to evaluate the effectiveness of the use of biofeedback in the treatment of aggressive episodes in children and adolescents. BACKGROUND: Aggressive episodes are common in various disorders and are associated with deficits in emotional processing and impulse control, primarily due to dysfunctions in the amygdala and prefrontal cortex (PFC). These brain regions also regulate physiological arousal, influencing heart rate and other autonomic functions even before aggression manifests. These early signals can be shown to the person (biofeedback) reinforcing therapeutic skills to enhance emotional regulation and reduce aggression. METHODS: A total of 70 participants will be recruited for a randomized controlled trial (RCT). All participants will receive therapy, although only the intervention group will incorporate biofeedback. The experimental study will be split into three blocks: (1) Home Monitoring: Physiological signals will be recorded using a smartwatch, and aggressive episodes will be captured with a camera; (2) Laboratory Assessment: Participants will attend three sessions, where therapists will induce aggressive reactions, using the video clips recorded at home. Simultaneously, real-time physiological signals will be measured. These sessions will also include relaxation periods before and after the provoked outburst; (3) Therapeutic Intervention: Similar to the laboratory assessment block, therapists will induce aggressive responses in three sessions; however, in this block, participants will receive therapy. Additionally, participants who belong to the intervention group, will include biofeedack in the therapy. Biofeedback is focused on heart rate (HR), heart rate variability (HRV), and skin conductance level (SCL). The CACIA, the Stroop, and other pre- and post-experimental tests. will be used to assess the differences between the control and intervention groups. DISCUSSION: Emotions play a fundamental role in decision-making, social interactions, and mental health. Emotional dysregulation often leads to aggression, irritability, and anxiety. Showing physiological responses to patients, such as heart rate variability and skin conductance, may improve emotional awareness and regulation. This study aims to verify the effectiveness of including biofeedback in such therapy.
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Molina-Cantero et al. (2025) conducted an RCT in Aggressive outbursts (n=70). Biofeedback integrated into therapy vs. Therapy without biofeedback was evaluated on Differences in CACIA, Stroop, and other pre- and post-experimental tests. This study protocol outlines a planned randomized controlled trial to evaluate the effectiveness of integrating biofeedback into therapy for aggressive outbursts in 70 children and adolescents.
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