MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)

Evaluating the Efficacy of the MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for 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.

Inclusion Criteria:

• Sex: All
• 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.