A Phase 1 interventional study of Virtual Reality and Standard Psychotherapy in Traumatic Brain Injuries, TBI (Traumatic Brain Injury) and MTBI - Mild Traumatic Brain Injury, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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
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
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 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.
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.
Time frame: Baseline, midpoint assessment at approximately 3 weeks, final post-intervention assessment approximately 1 week post completion of the six-week intervention.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.