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Completed NCT07462312

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

Conditions: PTSD - Post Traumatic Stress Disorder

Sex: Male
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: NeuroBrave ltd.

Location: NeuroBrave LTD - Remote Site Jerusalem

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 to 50 Years. * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07462312). StuddyBuddy aggregates publicly available trial information.