Digital Biofeedback for Combat Veterans Diagnosed With PTSD
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),
| Condition(s) | PTSD - Post Traumatic Stress Disorder |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 PTS |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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. * Medica |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Lead sponsor | NeuroBrave ltd. |
| Locations | Jerusalem, Israel |
| Start date | 2025-09-15 |
| NCT ID | NCT07462312 |
| Official listing | https://clinicaltrials.gov/study/NCT07462312 |