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RECRUITINGINTERVENTIONAL

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Evaluating the Efficacy of the "Mental Gym®" Biofeedback-Based Intervention for Combat Veterans Diagnosed With PTSD: A Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Mental Gym® Biofeedback System

The intervention is an 8-week hybrid program designed to reduce symptoms of PTSD and improve mental health. The program includes weekly online sessions (via Zoom) with a specialist psychologist experienced in biofeedback and trauma therapy. These sessions guide participants through the program, provide education on trauma and autonomic system and explain the biofeedback exercises. In addition to the weekly group sessions, participants engage in a dailyself-practice delivered through the NeuroBrave Sense mobile application, utilizing the provided wearable device ( Garmin watch) for real time biofeedback practices. Supplementary mental practice assignments are also delivered to participants via WhatsApp.

Locations (1)

NeuroBrave LTD - Remote Site
Jerusalem, Israel