PTSDNCT07213596
Virtual Reality Treatment for Trauma Related to COVID-19 Infection
A study testing VR Exposure Therapy, Cognitive Behavioral Therapy (CBT) and Supportive Psychotherapy in people with PTSD and PTSD Symptoms, run by Soonchunhyang University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, PTSD Symptoms
- What is being tested?
- VR Exposure Therapy, Cognitive Behavioral Therapy (CBT) and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-64, healthy population who survived from COVID-19 (COVID survivors) or Healthcare Workers with PCL-5 ≥10, GAD-7/PHQ-9 ≥10
Who cannot join
- Pregnancy, neurological disorders, severe medical conditions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of Virtual Reality Treatment Technology to Treat Trauma Related to COVID-19 Infection
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.
Read the 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
- PTSD, PTSD Symptoms
- Being tested
- VR Exposure Therapy, Cognitive Behavioral Therapy (CBT), Supportive Psychotherapy
- Keywords
- VR exposure, PTSD symptoms, covid 19
- Medical subject headings
- Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Exposure TherapyBehavioural
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.
Cognitive Behavioral Therapy (CBT)Behavioural
Face-to-face CBT with exposure elements, targeting trauma-related symptoms. Administered in 5 weekly sessions.
Supportive PsychotherapyBehavioural
Therapist-led supportive therapy (TAU), focusing on empathy, validation, and emotional support without structured exposure.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers with VR Exposure Therapy | Experimental | Healthcare workers with VR Exposure Therapy with 5 sessions weekly Receives: Behavioral: VR Exposure Therapy |
| COVID-19 survivors with VR Exposure Therapy | Experimental | general population with VR Exposure Therapy with 5 sessions weekly Receives: Behavioral: VR Exposure Therapy |
| Healthcare workers with CBT | Active comparator | Healthcare workers with CBT with weekly 5 sessions Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| COVID-19 survivor with Supportive Therapy/TAU | Active comparator | individual recovered from COVID-19 with Supportive Therapy/TAU Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms
Change in PTSD symptoms (PCL-5/CAPS-5) at baseline, week 5, 3-mo follow-up
Measured: baseline, week 5, 3-mo follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Sun Kim, Soonchunhyang University Hospital
- Investigators
- Ji Sun Kim, MD, PhD, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213596
- Sponsor's protocol ID
- SCHCA IRB 2022-08-032-033
- Other IDs
- RS-2022-KH125605
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant data (IPD) will not be shared due to confidentiality concerns and regulatory restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Virtual Reality Treatment Technology to Treat Trauma Related to COVID-19 Infection
- ClinicalTrials.gov ID
- NCT07213596
- Acronym / sponsor ID
- SCHCA IRB 2022-08-032-033
- Conditions
- PTSD, PTSD Symptoms
- Keywords
- VR exposure, PTSD symptoms, covid 19
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers with VR Exposure Therapy | Experimental | Behavioral: VR Exposure TherapyHealthcare workers with VR Exposure Therapy with 5 sessions weekly |
| COVID-19 survivors with VR Exposure Therapy | Experimental | Behavioral: VR Exposure Therapygeneral population with VR Exposure Therapy with 5 sessions weekly |
| Healthcare workers with CBT | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)Healthcare workers with CBT with weekly 5 sessions |
| COVID-19 survivor with Supportive Therapy/TAU | Active comparator | Behavioral: Supportive Psychotherapyindividual recovered from COVID-19 with Supportive Therapy/TAU |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-64, healthy population who survived from COVID-19 (COVID survivors) or Healthcare Workers with PCL-5 ≥10, GAD-7/PHQ-9 ≥10
Key exclusion criteria (1 listed)
- Pregnancy, neurological disorders, severe medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Exposure TherapyVirtual 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. | Behavioural | COVID-19 survivors with VR Exposure Therapy, Healthcare workers with VR Exposure Therapy |
| Cognitive Behavioral Therapy (CBT)Face-to-face CBT with exposure elements, targeting trauma-related symptoms. Administered in 5 weekly sessions. | Behavioural | Healthcare workers with CBT |
| Supportive PsychotherapyTherapist-led supportive therapy (TAU), focusing on empathy, validation, and emotional support without structured exposure. | Behavioural | COVID-19 survivor with Supportive Therapy/TAU |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No. No. Individual participant data (IPD) will not be shared due to confidentiality concerns and regulatory restrictions.
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ji Sun Kim, MD, PhD principal investigator
Soonchunhyang University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing VR Exposure Therapy, Cognitive Behavioral Therapy (CBT) and Supportive Psychotherapy in people with PTSD and PTSD Symptoms, run by Soonchunhyang University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Sun Kim, MD, PhD (82-10-9933-1286, ideal91@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms (time frame: baseline, week 5, 3-mo follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.