Virtual Reality Treatment for Trauma Related to COVID-19 Infection

NCT07213596 | Not Yet Recruiting DMC

• 2 other identifiers: SCHCA IRB 2022-08-032-033RS-2022-KH125605
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTSD; PTSD Symptoms

Keywords

VR exposure; PTSD symptoms; covid 19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Healthcare workers with VR Exposure Therapy

EXPERIMENTAL

Healthcare workers with VR Exposure Therapy with 5 sessions weekly

Behavioral: VR Exposure Therapy

COVID-19 survivors with VR Exposure Therapy

EXPERIMENTAL

general population with VR Exposure Therapy with 5 sessions weekly

Behavioral: VR Exposure Therapy

Healthcare workers with CBT

ACTIVE COMPARATOR

Healthcare workers with CBT with weekly 5 sessions

Behavioral: Cognitive Behavioral Therapy (CBT)

COVID-19 survivor with Supportive Therapy/TAU

ACTIVE COMPARATOR

individual recovered from COVID-19 with Supportive Therapy/TAU

Behavioral: Supportive Psychotherapy

Interventions

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.

COVID-19 survivors with VR Exposure Therapy; Healthcare workers with VR Exposure Therapy

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Face-to-face CBT with exposure elements, targeting trauma-related symptoms. Administered in 5 weekly sessions.

Healthcare workers with CBT

Supportive Psychotherapy BEHAVIORAL

Therapist-led supportive therapy (TAU), focusing on empathy, validation, and emotional support without structured exposure.

COVID-19 survivor with Supportive Therapy/TAU

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-64, healthy population who survived from COVID-19 (COVID survivors) or Healthcare Workers with PCL-5 ≥10, GAD-7/PHQ-9 ≥10

You may not qualify if:

• Pregnancy, neurological disorders, severe medical conditions

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; COVID-19

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ji Sun Kim, MD, PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share