Efficacy and Safety of Emotion-to-Emotion Therapy Versus Virtual Reality-based Emotion to Emotion Therapy for Treatment of Hwabyung: A protocol for a single-center, randomized, assessor-blind, parallel-group clinical trial

Background: Hwa-Byung is a prevalent neuropsychiatric disorder in South Korea, where accumulated anger and associated symptoms significantly impair family, work, and personal relationships. Given the limitations of pharmacological treatments, there is a need for effective non-pharmacological alternatives. Emotion-to-Emotion Therapy (ETE) has shown promise in managing the psychological and physical symptoms of Hwa-Byung. Additionally, virtual reality (VR) is emerging as a beneficial adjunct to psychotherapy. This study compares the efficacy and safety of VR-based ETE with ETE alone. Methods: This single-center, randomized, assessor-blind, parallel-group clinical trial will enroll 96 participants, divided equally among two experimental groups and one control group. Over eight weeks, each participant will undergo 12 intervention sessions. Experimental Group 1 will receive conventional ETE, Experimental Group 2 will receive VR-based ETE and the control group will receive Hwa-Byung management training materials. The primary outcome will measure changes in the Likert Scale for Major Symptoms of Hwa-Byung from baseline to 8 weeks. Secondary outcomes will include the Core Seven-Emotions Inventory Short Form, Physical Health Questionnaire, Stress Response Index, Beck Depression Inventory, State-Trait Anger Expression Inventory, State-Trait Anxiety Inventory, functional Near-infrared Spectroscopy, and Heart Rate Variability. Discussion: ETE is known as effective oriental psychotherapy that enhances symptom management, self-regulation, and stress coping. VR is anticipated to enrich treatment immersion. These strengths being combined, this study will explore VR-based ETE's potential to ameliorate Hwa-Byung symptoms, assessing its clinical effectiveness relative to conventional ETE. Trial registration number: KCT0007871 (Registered in Clinical Research Information Service of the Republic of Korea); registered on 2022/11/03(https://cris.nih.go.kr/cris/search/detailSearch.do/27510))