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