Virtual Reality Treatment for Trauma Related to COVID-19 Infection

Soon Chun Hyang University

Status: Not yet enrolling

Conditions: PTSD Symptoms; PTSD

Treatments: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Supportive Psychotherapy; Behavioral: VR Exposure Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07213596

SCHCA IRB 2022-08-032-033

RS-2022-KH125605 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Healthcare workers with VR Exposure Therapy

Experimental group

Description:

Healthcare workers with VR Exposure Therapy with 5 sessions weekly

Treatment:

Behavioral: VR Exposure Therapy

COVID-19 survivors with VR Exposure Therapy

Experimental group

Description:

general population with VR Exposure Therapy with 5 sessions weekly

Treatment:

Behavioral: VR Exposure Therapy

Healthcare workers with CBT

Active Comparator group

Description:

Healthcare workers with CBT with weekly 5 sessions

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

COVID-19 survivor with Supportive Therapy/TAU

Active Comparator group

Description:

individual recovered from COVID-19 with Supportive Therapy/TAU

Treatment:

Behavioral: Supportive Psychotherapy