Recruiting
Phase 1

VR & Psychotherapy

Sponsor:

Johns Hopkins University

Code:

NCT07890337

Conditions

Traumatic Brain Injuries

TBI (Traumatic Brain Injury)

MTBI - Mild Traumatic Brain Injury

mTBI

Traumatic Brain Injury | Patient

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Standard Psychotherapy

Study Details

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

Study ID

NCT07890337

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ReVIVE Virtual Reality + Standard Care

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.

active comparator: Standard Care Only

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Saumik Das

703-554-0332sdas41@jh.edu

Durga Roy, MD

droy4@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center - Pyschiatry

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Durga Roy, MD

505-264-9795droy4@jhmi.edu

Principal Investigator:

Durga Roy, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.