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| ID | Type | Description | Link |
|---|---|---|---|
| RS-2022-KH125605 | Other Grant/Funding Number | the Ministry of Health and Welfare, Republic of Korea |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthcare workers with VR Exposure Therapy | Experimental | Healthcare workers with VR Exposure Therapy with 5 sessions weekly |
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| COVID-19 survivors with VR Exposure Therapy | Experimental | general population with VR Exposure Therapy with 5 sessions weekly |
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| Healthcare workers with CBT | Active Comparator | Healthcare workers with CBT with weekly 5 sessions |
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| COVID-19 survivor with Supportive Therapy/TAU | Active Comparator | individual recovered from COVID-19 with Supportive Therapy/TAU |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR Exposure Therapy | Behavioral | 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. |
| Measure | Description | Time 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Sun Kim, MD, PhD | Contact | 82-10-9933-1286 | ideal91@hanmail.net | |
| Min Jung Park, RN | Contact | +82-10-4115-2642 | 0705pmj@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji Sun Kim, MD, PhD | Soonchunhyang University Hospital | Principal Investigator |
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No. Individual participant data (IPD) will not be shared due to confidentiality concerns and regulatory restrictions.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Behavioral Therapy (CBT) | Behavioral | Face-to-face CBT with exposure elements, targeting trauma-related symptoms. Administered in 5 weekly sessions. |
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| Supportive Psychotherapy | Behavioral | Therapist-led supportive therapy (TAU), focusing on empathy, validation, and emotional support without structured exposure. |
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| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |