Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
MALE
NCT07462312

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Led by NeuroBrave ltd. · Updated on 2026-03-10

80

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Who Can Participate

Age: 18Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male sex
  • Age 18 years and older
  • Clinical diagnosis of PTSD with mild to moderate-severe symptoms
  • PCL-5 total score up to 60 at screening
  • PTSD diagnosis based on a traumatic event from year 2000 or later
  • Eligibility for Ministry of Defense rehabilitation services
  • Ability to use a smartphone and wearable device
Not Eligible

You will not qualify if you...

  • PTSD symptom severity above moderate-severe range (PCL-5 score > 60) or needing intensive clinical intervention
  • Acute psychiatric instability including active suicidal thoughts or psychosis
  • Current use of Olanzapine (Zyprexa) or Quetiapine (Seroquel)
  • Severe sleep impairment (Insomnia Severity Index score > 7)
  • Severe concentration or cognitive impairment preventing use of digital biofeedback tools

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NeuroBrave LTD - Remote Site

Jerusalem, Israel

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Digital Biofeedback for Combat Veterans Diagnosed With PTSD | DecenTrialz