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RECRUITING
NCT07890337
PHASE1

Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

The primary goal of this study is to evaluate the effectiveness of an integrated therapeutic model - combining VR and standard psychotherapy in improving executive function and hyperarousal adults impacted with mTBI. Specifically, the study will: Evaluate PTSD Symptom Reduction - PTSD symptoms, specifically hyperarousal and hypervigilance will be assessed using the Davidson Trauma Scale, which will provide insight into improvements PTSD symptom reduction.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-10

Completion Date

2028-05

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DEVICE

Virtual Reality

ReVIVE is a virtual reality (VR)-based rehabilitation intervention delivered over six weekly sessions as an adjunct to standard care for individuals with PTSD following mild traumatic brain injury (mTBI). Using an Oculus Quest VR headset, participants complete approximately 10 minutes of acclimation followed by 30 minutes of immersive activities. The intervention incorporates mindfulness, breathing and grounding exercises, emotional regulation, and cognitive and functional activities within simulated everyday environments. Scenarios are designed to support engagement with progressively more complex environments and tasks. Intervention tolerability is monitored using the Simulator Sickness Questionnaire before and after VR sessions. Standard care, including routine psychotherapy and medication management, continues throughout the study.

BEHAVIORAL

Standard Psychotherapy

Standard psychotherapy consists of ongoing therapy received by participants before enrollment and continued throughout the study as part of the participants usual care. Sessions focus on identifying emotions, recognizing cognitive shifts and difficulties, supporting real-time emotional and cognitive regulation, and facilitating interpersonal processing and emotional labeling. Psychotherapy frequency and treatment decisions remain at the discretion of participants' treating clinicians and are not standardized or altered by the study. Participants assigned to the control arm continue standard psychotherapy and medication management without receiving the study's virtual reality intervention.

Locations (1)

Johns Hopkins Bayview Medical Center - Pyschiatry

Baltimore, Maryland, United States