NCT07462312 Digital Biofeedback for Combat Veterans Diagnosed With PTSD
| NCT ID | NCT07462312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NeuroBrave ltd. |
| Condition | PTSD - Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-09-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. * 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.
Frequently Asked Questions
Who can join the NCT07462312 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying PTSD - Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07462312 currently recruiting?
Yes, NCT07462312 is actively recruiting participants. Visit ClinicalTrials.gov or contact NeuroBrave ltd. to inquire about joining.
Where is the NCT07462312 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT07462312 clinical trial?
NCT07462312 is sponsored by NeuroBrave ltd.. The trial plans to enroll 80 participants.
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