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ReVIVENCT07890337

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

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below.

  1. Minor Start date pushed from Oct 2026 to Nov 2026
  2. Minor Site contact updated
  3. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

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

Arms and interventions

ReVIVE Virtual Reality + Standard CareExperimental

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.

Standard Care OnlyActive 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.

Devices: Virtual Reality

Behavioral: Standard Psychotherapy

Sites

1 site in 1 country

  • Johns Hopkins Bayview Medical Center - PyschiatryBaltimore, Maryland, United States