Development of Virtual Reality Treatment Technology to Treat Trauma Related to COVID-19 Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Primary Endpoint
- Change in PTSD symptoms
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-64, healthy population who survived from COVID-19 (COVID survivors) or Healthcare Workers with PCL-5 ≥10, GAD-7/PHQ-9 ≥10
Exclusion Criteria
- •Pregnancy, neurological disorders, severe medical conditions
Arms & Interventions
Healthcare workers with VR Exposure Therapy
Healthcare workers with VR Exposure Therapy with 5 sessions weekly
Intervention: VR Exposure Therapy (Behavioral)
COVID-19 survivors with VR Exposure Therapy
general population with VR Exposure Therapy with 5 sessions weekly
Intervention: VR Exposure Therapy (Behavioral)
Healthcare workers with CBT
Healthcare workers with CBT with weekly 5 sessions
Intervention: Cognitive Behavioral Therapy (CBT) (Behavioral)
COVID-19 survivor with Supportive Therapy/TAU
individual recovered from COVID-19 with Supportive Therapy/TAU
Intervention: Supportive Psychotherapy (Behavioral)
Outcomes
Primary Outcomes
Change in PTSD symptoms
Time Frame: baseline, week 5, 3-mo follow-up
Change in PTSD symptoms (PCL-5/CAPS-5) at baseline, week 5, 3-mo follow-up
Secondary Outcomes
No secondary outcomes reported
Investigators
Ji Sun Kim
Professor
Soonchunhyang University Hospital