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

• 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.
• 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.

Primary outcomes

• Change in PTSD Symptom Severity Measured by the Davidson Trauma Scale (DTS) [Baseline, midpoint assessment at approximately 3 weeks, final post-intervention assessment approximately 1 week post completion of the six-week intervention.]: 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.

Sex: All, ages: 18 Years to 55 Years

Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

• Saumik Das, Study director, Johns Hopkins University
• Durga Roy, MD, Principal investigator, Johns Hopkins University