Trials / Not Yet Recruiting
Not Yet RecruitingNCT07213596
Virtual Reality Treatment for Trauma Related to COVID-19 Infection
Development of Virtual Reality Treatment Technology to Treat Trauma Related to COVID-19 Infection
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Soonchunhyang University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
This clinical trial aims to develop and evaluate the effectiveness of virtual reality (VR)-based exposure therapy for trauma symptoms related to COVID-19 infection. The intervention targets healthcare workers and individuals from the general population who experienced pandemic-related psychological distress. The study assesses psychological and physiological outcomes, including PTSD, anxiety, depression, HRV, and EEG biomarkers.
Detailed description
The project involves a two-phase clinical study. In Phase 1, VR exposure therapy content is developed based on trauma management theory and tailored to specific participant groups (e.g., COVID-19 survivors, healthcare workers). In Phase 2, randomized controlled trials will compare VR treatment with standard therapy approaches (CBT, supportive therapy) across two populations: Healthcare workers involved in the care of COVID-19 patients Members of the general public affected by social disaster-related psychological distress Participants will undergo 5 weekly sessions of VR exposure therapy. Pre- and post-intervention assessments will include standardized psychiatric scales (e.g., PHQ-9, PCL-5), HRV, and EEG measurements. The trial aims to validate the efficacy and safety of customized VR therapy protocols and identify relevant biomarkers for treatment prediction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | VR Exposure Therapy | Virtual Reality Exposure Therapy (VRET) is a form of psychotherapy that uses immersive virtual environments to simulate trauma-related stimuli in a controlled and safe setting, allowing individuals to gradually confront and process distressing memories or triggers. VRET is grounded in prolonged exposure (PE) therapy, a well-established treatment for PTSD and anxiety disorders. In this study, VRET is delivered in 5 weekly sessions, each lasting approximately 50 minutes, using a customized VR system. Sessions are tailored based on participant group (e.g., COVID-19 survivor vs. healthcare worker). Each session includes psychoeducation, exposure to individualized trauma-related virtual scenes, and guided emotional processing. The system incorporates eye-tracking, breathing exercises, and real-time subjective distress scaling (SUDs) to monitor engagement and safety. |
| BEHAVIORAL | Cognitive Behavioral Therapy (CBT) | Face-to-face CBT with exposure elements, targeting trauma-related symptoms. Administered in 5 weekly sessions. |
| BEHAVIORAL | Supportive Psychotherapy | Therapist-led supportive therapy (TAU), focusing on empathy, validation, and emotional support without structured exposure. |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2026-12-31
- Completion
- 2027-07-31
- First posted
- 2025-10-09
- Last updated
- 2025-10-09
Source: ClinicalTrials.gov record NCT07213596. Inclusion in this directory is not an endorsement.