Real-world outcomes of an innovative digital therapeutic for treatment of panic disorder and PTSD: A 1,500 patient effectiveness study.
Robert N Cuyler, Rahul Katdare, Simon Thomas...
https://pubmed.ncbi.nlm.nih.gov/36465089Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
MALE
ID07462312
Evaluating the Efficacy of the Mental Gym® Biofeedback-Based Intervention for Combat Veterans Diagnosed With PTSD: A Randomized Controlled Trial
Led by NeuroBrave ltd. · Updated on 2026-03-10
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is focused on combat veterans diagnosed with Posttraumatic Stress Disorder (PTSD). Researchers are evaluating a digital biofeedback-based program called "Mental Gym®" to reduce PTSD symptoms and improve mental health. This randomized controlled trial (RCT) includes participants with mild to moderate-severe PTSD symptoms and aims to assess the intervention's effects compared to delayed treatment. The study is sponsored by NeuroBrave ltd. and uses a randomized design without masking. The intervention lasts 8 weeks and combines daily heart rate variability (HRV) biofeedback exercises guided by a wearable Garmin watch and a mobile app with weekly online group sessions led by a psychologist experienced in trauma and biofeedback therapy. Participants in the control group initially continue usual treatment for 8 weeks before receiving the full intervention. Additional mental practice assignments are provided through WhatsApp. Physiological and self-report data are collected before and after the intervention. Participants will complete assessments at baseline, weekly during the intervention, and at follow-ups 1.5 and 3 months post-intervention. Measurements include PTSD symptom severity (PCL-5), autonomic regulation (resting HRV), anxiety (GAD-7), depression (PHQ-9), psychological resilience (CD-RISC-10), and sleep quality (ISI). The study tracks changes in these outcomes to evaluate treatment effects and monitors safety throughout the process. Total participation spans the intervention and follow-up periods.
CONDITIONS
Brief Title
Digital Biofeedback for Combat Veterans Diagnosed With PTSD
Who Can Participate
Age: 18Years - 50Years
MALE
Eligibility Criteria
You may qualify if you...
- Male sex
- Age 18 years and older
- Clinical diagnosis of PTSD with mild to moderate-severe symptoms
- PCL-5 score up to 60 at screening
- PTSD related to traumatic event from year 2000 or later
- Eligible for Ministry of Defense rehabilitation services
- Ability to use a smartphone and wearable device
You will not qualify if you...
- PTSD symptom severity exceeding moderate-severe range (PCL-5 score > 60) or needing more intensive care
- Acute psychiatric instability including active suicidal thoughts or psychosis
- Current use of Olanzapine (Zyprexa) or Quetiapine (Seroquel)
- Severe sleep impairment (ISI 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 8 weeks
Participants undergo an 8-week hybrid biofeedback program involving weekly online group sessions with a specialist psychologist and daily self-practice using a mobile app and wearable device to reduce PTSD symptoms and improve mental health.
Weekly online group sessions and daily self-practice using the mobile app and wearable device
Follow-up
Duration - Up to 12 weeks after treatment
Participants are monitored to assess the long-term retention of treatment effects after completing the intervention.
Visits at 1.5 months and 3 months post-intervention
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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Published Research Related To This Trial
A Pilot Study of a Three-Session Heart Rate Variability Biofeedback Intervention for Veterans with Posttraumatic Stress Disorder.
Donna L Schuman, Karen A Lawrence, Ian Boggero...
https://pubmed.ncbi.nlm.nih.gov/36331685Heart rate variability (HRV) and posttraumatic stress disorder (PTSD): a pilot study.
Gabriel Tan, Tam K Dao, Lorie Farmer...
https://pubmed.ncbi.nlm.nih.gov/20680439Breathing biofeedback as an adjunct to exposure in cognitive behavioral therapy hastens the reduction of PTSD symptoms: a pilot study.
A Rosaura Polak, Anke B Witteveen, Damiaan Denys...
https://pubmed.ncbi.nlm.nih.gov/25750106The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response.
Charles M Morin, Geneviève Belleville, Lynda Bélanger...
https://pubmed.ncbi.nlm.nih.gov/21532953The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation.
Christy A Blevins, Frank W Weathers, Margaret T Davis...
https://pubmed.ncbi.nlm.nih.gov/26606250The PHQ-9: validity of a brief depression severity measure.
K Kroenke, R L Spitzer, J B Williams
https://pubmed.ncbi.nlm.nih.gov/11556941Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC).
Kathryn M Connor, Jonathan R T Davidson
https://pubmed.ncbi.nlm.nih.gov/12964174A brief measure for assessing generalized anxiety disorder: the GAD-7.
Robert L Spitzer, Kurt Kroenke, Janet B W Williams...
https://pubmed.ncbi.nlm.nih.gov/16717171An abbreviated PTSD checklist for use as a screening instrument in primary care.
Ariel J Lang, Murray B Stein
https://pubmed.ncbi.nlm.nih.gov/15865914