Digital biofeedback program for combat veterans with PTSD
Evaluating the Efficacy of the "Mental Gym®" Biofeedback-Based Intervention for Combat Veterans Diagnosed With PTSD: A Randomized Controlled Trial
This program will try a smartphone app, a Garmin watch, and weekly group sessions (Mental Gym®) to see if they reduce PTSD symptoms in combat veterans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | NeuroBrave ltd. Industry-sponsored |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT07462312 on ClinicalTrials.gov |
What this trial studies
This is a randomized, delayed‑intervention controlled trial testing a digital biofeedback intervention that combines daily heart-rate-variability (HRV) exercises delivered via a Garmin wearable and a dedicated mobile app with weekly group guidance sessions. About 80 male combat veterans with a clinical PTSD diagnosis will be enrolled to achieve a final sample of roughly 60 participants. Physiological data from the wearable and self-report measures (including PCL-5) will be collected before and after the intervention, weekly during the intervention period, and at a 3‑month follow-up. The intervention aims to improve autonomic regulation and reduce PTSD symptom severity in veterans eligible for Ministry of Defense rehabilitation services.
Who should consider this trial
Good fit: Ideal participants are male combat veterans aged 18 or older with a clinical PTSD diagnosis (trauma in 2000 or later), a PCL-5 score up to 60, eligibility for Ministry of Defense rehabilitation services, and the ability to use a smartphone and wearable.
Not a fit: Patients with very severe PTSD (PCL-5 > 60), acute psychiatric instability (active suicidal ideation or psychosis), current use of olanzapine or quetiapine, severe sleep impairment, or inability to use a smartphone/wearable are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could reduce PTSD symptoms and improve stress regulation and daily functioning using an accessible digital approach.
How similar studies have performed: Small trials of HRV biofeedback and app-based interventions have shown promising but mixed results for PTSD and anxiety, while large RCTs of combined wearable-plus-group programs remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jerusalem
- NeuroBrave LTD - Remote Site — Jerusalem, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.