MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)

This randomized controlled trial (RCT) will evaluate the effectiveness of a digital biofeedback-based intervention ("Mental Gym®") designed to reduce Posttraumatic Stress Disorder (PTSD) symptoms and improve mental health. The intervention combines daily HRV biofeedback exercises using a wearable device (Garmin watch), a dedicated mobile application, and weekly group guidance sessions. A delayed-intervention control group design will be used. To account for expected attrition and ensure a final sample of 60 participants, approximately 80 subjects will be recruited. Physiological and self-report data will be collected pre- and post-intervention, weekly during the intervention, and at follow-ups (3 months post-intervention). The study population consists of combat veterans diagnosed with PTSD.

NCT Number	NCT07462312
Lead Sponsor	NeuroBrave ltd.
Conditions	PTSD - Post Traumatic Stress Disorder
Enrollment	80 participants
Start Date	2025-09-15
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-16