Digital Biofeedback for Combat Veterans Diagnosed With PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-50
SponsorNeuroBrave ltd.
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Mental Gym® Biofeedback System
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov