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RECRUITINGNA

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

NCT07462312•NeuroBrave ltd.

View on ClinicalTrials.gov

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

Age

18 - 50 years

Sex

MALE

Healthy Volunteers

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.

Locations (1)

NeuroBrave LTD - Remote Site

Jerusalem, Israel

Key Dates

Start Date

September 15, 2025

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

PTSD - Post Traumatic Stress Disorder

Interventions

Mental Gym® Biofeedback System

BEHAVIORAL

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RECRUITINGNA

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PTSD - Post Traumatic Stress Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Inclusion Criteria

Exclusion Criteria

Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany

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