Virtual Reality Treatment for Trauma Related to COVID-19 Infection

NCT ID: NCT07213596

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-07-31

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.

Conditions

PTSD; PTSD Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthcare workers with VR Exposure Therapy

Healthcare workers with VR Exposure Therapy with 5 sessions weekly

Group Type: EXPERIMENTAL

VR Exposure Therapy

Intervention Type: 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

general population with VR Exposure Therapy with 5 sessions weekly

Group Type: EXPERIMENTAL

VR Exposure Therapy

Intervention Type: 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.

Healthcare workers with CBT

Healthcare workers with CBT with weekly 5 sessions

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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

COVID-19 survivor with Supportive Therapy/TAU

individual recovered from COVID-19 with Supportive Therapy/TAU

Group Type: ACTIVE_COMPARATOR

Supportive Psychotherapy

Intervention Type: BEHAVIORAL

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

Interventions

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 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.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

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

Intervention Type: BEHAVIORAL

Supportive Psychotherapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji Sun Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji Sun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Central Contacts

Ji Sun Kim, MD, PhD

Role: CONTACT

ideal91@hanmail.net

82-10-9933-1286

Min Jung Park, RN

Role: CONTACT

0705pmj@naver.com

+82-10-4115-2642

Other Identifiers

RS-2022-KH125605

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SCHCA IRB 2022-08-032-033

Identifier Type: -

Identifier Source: org_study_id