NCT07462312

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Evaluating the Efficacy of the "Mental Gym®" Biofeedback-Based Intervention for Combat Veterans Diagnosed With PTSD: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: NeuroBrave ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PTSD - Post Traumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Mental Gym® Biofeedback System	The intervention is an 8-week hybrid program designed to reduce symptoms of PTSD and improve mental health. The program includes weekly online sessions (via Zoom) with a specialist psychologist experienced in biofeedback and trauma therapy. These sessions guide participants through the program, provide education on trauma and autonomic system and explain the biofeedback exercises. In addition to the weekly group sessions, participants engage in a dailyself-practice delivered through the NeuroBrave Sense mobile application, utilizing the provided wearable device ( Garmin watch) for real time biofeedback practices. Supplementary mental practice assignments are also delivered to participants via WhatsApp.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Israel