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Virtual Reality Treatment for Trauma Related to COVID-19 Infection 100 Biomarker-Driven Virtual

Not yet recruiting
Clinical Trial NCT07213596 is an interventional study for PTSD, PTSD Symptoms and is currently not yet recruiting. Enrollment is planned to begin on November 1, 2025 and continue until the study accrues 100 participants. Led by Soonchunhyang University Hospital, this study is expected to complete by July 31, 2027. The latest data from ClinicalTrials.gov was last updated on October 9, 2025.
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...Show More
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 o...

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Official Title

Development of Virtual Reality Treatment Technology to Treat Trauma Related to COVID-19 Infection

Conditions
PTSDPTSD Symptoms
Other Study IDs
  • SCHCA IRB 2022-08-032-033
  • RS-2022-KH125605 (Other Grant/Funding Number) (the Ministry of Health and Welfare, Republic of Korea)
NCT ID Number
NCT07213596
Start Date (Actual)
2025-11-01
Last Update Posted
2025-10-09
Completion Date (Estimated)
2027-07-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
VR exposure
PTSD symptoms
covid 19
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHealthcare workers with VR Exposure Therapy
Healthcare workers with VR Exposure Therapy with 5 sessions weekly
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 ...Show More
ExperimentalCOVID-19 survivors with VR Exposure Therapy
general population with VR Exposure Therapy with 5 sessions weekly
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 ...Show More
Active ComparatorHealthcare workers with CBT
Healthcare workers with CBT with weekly 5 sessions
Cognitive Behavioral Therapy (CBT)
Face-to-face CBT with exposure elements, targeting trauma-related symptoms. Administered in 5 weekly sessions.
Active ComparatorCOVID-19 survivor with Supportive Therapy/TAU
individual recovered from COVID-19 with Supportive Therapy/TAU
Supportive Psychotherapy
Therapist-led supportive therapy (TAU), focusing on empathy, validation, and emotional support without structured exposure.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in PTSD symptoms
Change in PTSD symptoms (PCL-5/CAPS-5) at baseline, week 5, 3-mo follow-up
baseline, week 5, 3-mo follow-up
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Age 18-64, healthy population who survived from COVID-19 (COVID survivors) or Healthcare Workers with PCL-5 ≥10, GAD-7/PHQ-9 ≥10

  • Pregnancy, neurological disorders, severe medical conditions
Soonchunhyang University Hospital logoSoonchunhyang University Hospital
Study Responsible Party
Ji Sun Kim, Principal Investigator, Professor, Soonchunhyang University Hospital
Study Central Contact
Contact: Ji Sun Kim, MD, PhD, 82-10-9933-1286, [email protected]
Contact: Min Jung Park, RN, +82-10-4115-2642, [email protected]
No location data.