What this study is
Simplified from ClinicalTrials.govTesting virtual reality therapy combined with standard talk therapy to improve executive function (skills like planning and focus) and hyperarousal (feeling constantly on edge) in adults ages 18 to 55 with mild traumatic brain injury.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Virtual Reality
Intervention · 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.
- Standard Psychotherapy
Intervention · 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.
Study details
- Sponsor
- Johns Hopkins University
- Conditions
- Traumatic Brain Injuries · TBI (Traumatic Brain Injury) · MTBI - Mild Traumatic Brain Injury · mTBI · Traumatic Brain Injury | Patient · Traumatic Brain Injury and Co-occurring Disorders · PTSD - Post Traumatic Stress Disorder
- Enrolling
- 30 people
- Starts
- 2026-10
- Est. completion
- 2028-05
- Design
- Open-label, randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openJohns Hopkins Bayview Medical Center - Pyschiatry
Baltimore, Maryland, United States
- Durga Roy, MD · Contact443-422-3506droy4@jhmi.edu
- Saumik Das · Sub-investigator
- Durga Roy, MD · Principal investigator
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00506142
Study director
Saumik Das
Johns Hopkins University
Principal investigator
Durga Roy, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.