RecruitingNot ApplicableNCT07462312

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

Sponsor

NeuroBrave ltd.

Enrollment

80 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

PTSD - Post Traumatic Stress Disorder

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital biofeedback tool for male combat veterans with PTSD. The app-based system uses a wearable device to track body stress signals in real time, helping veterans learn to manage their nervous system and reduce PTSD symptoms through feedback and exercises. **You may be eligible if...** - You are male and 18 years or older - You are a combat veteran with a clinical diagnosis of PTSD - Your PTSD symptoms are mild to moderately severe (PCL-5 score of 60 or below) - Your trauma occurred in the year 2000 or later - You are eligible for Ministry of Defense rehabilitation services - You can use a smartphone and wearable device **You may NOT be eligible if...** - Your PTSD symptoms are very severe (PCL-5 score above 60) - You have active suicidal thoughts or psychosis - You are unable or unwilling to use required technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMental 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.