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New treatment option for PTSD - Post Traumatic Stress Disorder
Official title MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)
ClinicalTrials.gov ID: NCT07462312
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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.
You likely can't join if
- High Symptom Severity: PTSD symptom severity exceeding the moderate-severe range (PCL-5 score \> 60) or requiring more intensive clinical...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.