MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP) (NCT07462312) | Clinical Trial Compass
RecruitingNot Applicable
MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)
Israel80 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sex: All
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PTSD Symptom Severity (PCL-5 Total Score)
Timeframe: Baseline (Week 0) and Post-Intervention (Week 8).