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
NeuroBrave ltd.
80 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Sex: Male
- Age: 18 Years and older.
- Diagnosis: Clinical diagnosis of Posttraumatic Stress Disorder (PTSD) with mild to moderate-severe symptom intensity.
- Symptom Severity: A PCL-5 total score of up to 60 at screening.
- Traumatic Event: PTSD diagnosis based on a traumatic event that occurred in the year 2000 or later.
- Service Eligibility: Eligibility for Ministry of Defense (MOD) rehabilitation services.
- Technical Proficiency: Ability to use a smartphone and a wearable device.
Exclusion Criteria5
- High Symptom Severity: PTSD symptom severity exceeding the moderate-severe range (PCL-5 score \> 60) or requiring more intensive clinical intervention.
- Psychiatric Stability: Acute psychiatric instability, including active suicidal ideation or psychosis.
- Medication: Current use of Olanzapine (Zyprexa) or Quetiapine (Seroquel).
- Sleep Disturbances: Severe sleep impairment (score \> 7 on the The Insomnia Severity Index).
- Functional Impairment: Severe impairment in concentration or cognitive processing that precludes the use of digital biofeedback tools.
Interventions
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.
Locations(1)
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NCT07462312