Post-traumatic stress disorder (PTSD) is a serious mental health condition that arises from experiencing or witnessing traumatic events. It is characterized by intrusive memories, heightened irritability, mood disturbances, and avoidance behaviors, significantly affecting daily functioning and overall quality of life. Current clinical guidelines recommend trauma-focused therapies as first-line treatments for PTSD, including various psychotherapeutic techniques.
Traditional Korean medicine has birthed Emotion-to-Emotion Therapy (ETE), which seeks to balance emotional responses by introducing opposing emotions, based on the principles of dysregulated emotions contributing to psychological and physical health issues. This therapy, in its original form, has shown potential but lacks rigorous evaluation, especially within the context of virtual reality (VR).
The incorporation of VR into psychotherapy offers an engaging, immersive platform for therapeutic interventions, providing controlled environments that can facilitate individualized treatment. However, existing VR interventions primarily focus on virtual exposure therapies. This trial represents the first exploration of a traditional Korean therapy for PTSD using VR, addressing a significant gap in current research.
This clinical trial is designed as a multicenter, randomized, three-arm, waitlist-controlled study, assessing VR-ETE against standard ETE and a waitlist control. A total of 72 adult participants diagnosed with PTSD will be randomized in equal ratios to one of the three groups. Participants in both experimental groups will engage in 16 therapeutic sessions over an 8-week period. The trial also includes a follow-up assessment at week 12 to evaluate treatment durability.
The primary endpoint focuses on the difference in the Korean version of the PTSD Checklist for DSM-5 (PCL-5-K) total score between the groups at week 8, accounting for baseline values and study site. Secondary outcomes will be measured using a variety of validated self-report inventories related to emotional awareness, mindfulness, depression, anxiety, insomnia, and overall health-related quality of life.
Participants will be recruited through various channels, such as online advertisements and public notices in hospitals. Inclusion criteria will target adults aged 18 to 70 meeting DSM-5 diagnostic criteria for PTSD, confirmed through standardized assessment measures. Exclusion criteria involve a range of severe psychiatric disorders, risk factors for symptom exacerbation, ongoing substance dependency, and certain physical health conditions.
Participants assigned to both VR-ETE and standard ETE will receive individual sessions where ETE is structured into five key stages, each designed to guide emotional regulation and awareness through a series of established therapeutic techniques. The VR-ETE utilizes Meta Oculus Quest 2 technology to create an immersive therapeutic experience while maintaining therapeutic fidelity to standard ETE procedures.
The VR intervention includes guided meditations and emotional regulation exercises, wherein participants engage in immersive meditation experiences tailored to manage their emotional responses effectively. This approach aims to enhance engagement and therapeutic outcomes by leveraging the capabilities of VR technology, providing aspects of treatment previously unattainable in conventional formats.
Randomization is managed through an independent statistician, ensuring concealment of allocation sequences throughout the trial. Participants cannot be blinded to their treatment group due to the nature of the interventions, thus limiting potential bias. However, trained, independent assessors who collect outcome data will remain unaware of group allocations to enhance objectivity.
Outcome assessments will focus on various standardized instruments to quantify symptoms and functional status. Besides the PCL-5-K, secondary measures include the Core Seven-Emotions Inventory, Five Facet Mindfulness Questionnaire, Hospital Anxiety and Depression Scale, and others. This multi-faceted assessment approach will provide a comprehensive understanding of treatment effectiveness over time.
Finding robust evidence from this trial will fill a crucial research void regarding the effectiveness of traditional therapeutic approaches combined with modern delivery systems like VR. Results will inform future therapy enhancements and potential clinical implementations, as well as economic evaluations pertaining to health resource management.
This study has been registered with the Clinical Research Information Service of the Republic of Korea, with the registration number KCT0007845, ensuring transparency and reproducibility throughout the research process. Further information and results will be disclosed upon study completion, adhering to ethical standards and participant privacy.