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

NCT07890337 | Recruiting Phase 1 DMC

• 2 other identifiers: IRB0050614280038668
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injuries; TBI (Traumatic Brain Injury); MTBI - Mild Traumatic Brain Injury; mTBI; Traumatic Brain Injury | Patient; PTSD - Post Traumatic Stress Disorder; Traumatic Brain Injury and Co-occurring Disorders

Keywords

traumatic brain injury; post traumatic stress disorder; digital therapeutics; virtual reality

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptom Severity Measured by the Davidson Trauma Scale (DTS)

  PTSD-related symptom severity will be assessed using the 17-item Davidson Trauma Scale (DTS), a self-report measure evaluating the frequency and severity of trauma-related symptoms, including intrusion, avoidance, and hyperarousal. Changes in DTS scores will be evaluated over the study period. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher score worse severity/frequency.

  Baseline, midpoint assessment at approximately 3 weeks, final post-intervention assessment approximately 1 week post completion of the six-week intervention.

Study Arms (2)

ReVIVE Virtual Reality + Standard Care

EXPERIMENTAL

Participants randomized to this arm will receive six weekly sessions of virtual reality (VR)-based rehabilitation in addition to standard care, including routine psychotherapy and medication management. Each session includes approximately 10 minutes of VR acclimation followed by 30 minutes of immersive VR activities designed to support emotional regulation, cognitive functioning, and functional rehabilitation. Activities incorporate mindfulness, breathing and grounding techniques, and everyday environments and tasks, with scenarios progressing in complexity. Intervention tolerability will be monitored using the Simulator Sickness Questionnaire administered before and after VR sessions.

Device: Virtual Reality; Behavioral: Standard Psychotherapy

Standard Care Only

ACTIVE COMPARATOR

Participants randomized to this arm will continue receiving standard care, including routine psychotherapy and medication management, without the addition of virtual reality (VR)-based rehabilitation. Participants will still complete study assessments at the scheduled time points to evaluate changes PTSD-related symptoms over the study period.

Behavioral: Standard Psychotherapy

Interventions

Virtual Reality DEVICE

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.

ReVIVE Virtual Reality + Standard Care

Standard Psychotherapy BEHAVIORAL

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.

ReVIVE Virtual Reality + Standard Care; Standard Care Only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of one or more concussions.
• Presence of mild-to-moderate PTSD symptoms, defined as a score between 20 and 44 on the Davidson Trauma Scale (DTS), indicating clinically relevant but not severe symptomatology (Davidson et al., 1997).
• Prior or ongoing therapy, defined as current or recent (within the last 3 months) engagement in standard care treatments such as psychiatric medication management, and evidence-based psychotherapy targeting mTBI or PTSD symptoms.
• Prior U.S military service (any duration and any branch) is required for eligibility.

You may not qualify if:

• Age over 55 to reduce confounding effects of age-related neurodegeneration and cognitive decline.
• Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
• Active substance abuse.
• Presence of unrelated neurological conditions such as epilepsy, stroke, seizure disorders, or neurodegenerative diseases (e.g., Alzheimer's, Parkinson's).
• Significant cognitive impairment, assessed by standardized cognitive screening, which would interfere with the ability to participate fully in VR and therapy sessions.
• Physical impairments that would prevent safe engagement in VR and therapy.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center - Pyschiatry

Baltimore, Maryland, 21218, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Saumik Das

  Johns Hopkins University

  STUDY DIRECTOR

• Durga Roy, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saumik Das

CONTACT

703-554-0332; sdas41@jh.edu

Durga Roy, MD

CONTACT

droy4@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized into one of two groups: VR + standard care or standard care alone. Participants remain in assigned group throughout the study.

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)