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Recruiting NCT07462312

MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)

No phase Interventional PTSD - Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mental Gym® Biofeedback System.
Who it may be relevant to
Registry conditions: PTSD - Post Traumatic Stress Disorder. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Efficacy of the MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD: A Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral Mental Gym® Biofeedback System
    The intervention is an 8-week hybrid program designed to reduce symptoms of PTSD and improve mental health. The program includes weekly online sessions (via Zoom) with a specialist psychologist experienced in biofeedback and trauma therapy. These sessions guide participants through the program, provide education on trauma and autonomic system and explain the biofeedback exercises. In addition to the weekly group sessions, participants engage in a dailyself-practice delivered through the NeuroBra

Primary outcome measures

  • Change in PTSD Symptom Severity (PCL-5 Total Score) [Time frame: Baseline (Week 0) and Post-Intervention (Week 8).]
Secondary outcome measures (6)
  • Long term retention of Treatment Effects in the Intervention Group [Time frame: Baseline (Week 0), Post-Intervention (Week 8), 1.5-month Follow-up (Week 14), and 3-month Follow-up (Week 20)]
  • Change in Autonomic Regulation (Resting HRV) [Time frame: Baseline (Week 0) and Post-Intervention (Week 8)]
  • Change in Generalized Anxiety Symptoms (GAD-7) [Time frame: Baseline (Week 0) and Post-Intervention (Week 8)]
  • Change in Depressive Symptoms (PHQ-9) [Time frame: Baseline (Week 0), Post-Intervention (Week 8)]
  • Change in Psychological Resilience (CD-RISC-10) [Time frame: Baseline (Week 0), Post-Intervention (Week 8)]
  • Change in Sleep Quality (ISI) [Time frame: Baseline (Week 0), Post-Intervention (Week 8)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • NeuroBrave LTD - Remote Site — Jerusalem

Publications

  • Cuyler RN, Katdare R, Thomas S, Telch MJ. Real-world outcomes of an innovative digital therapeutic for treatment of panic disorder and PTSD: A 1,500 patient effectiveness study. Front Digit Health. 2022 Nov 17;4:976001. doi: 10.3389/fdgth.2022.976001. eCollection 2022. PMID 36465089
  • Schuman DL, Lawrence KA, Boggero I, Naegele P, Ginsberg JP, Casto A, Moser DK. A Pilot Study of a Three-Session Heart Rate Variability Biofeedback Intervention for Veterans with Posttraumatic Stress Disorder. Appl Psychophysiol Biofeedback. 2023 Mar;48(1):51-65. doi: 10.1007/s10484-022-09565-z. Epub 2022 Nov 4. PMID 36331685
  • Tan G, Dao TK, Farmer L, Sutherland RJ, Gevirtz R. Heart rate variability (HRV) and posttraumatic stress disorder (PTSD): a pilot study. Appl Psychophysiol Biofeedback. 2011 Mar;36(1):27-35. doi: 10.1007/s10484-010-9141-y. PMID 20680439
  • Rosaura Polak A, Witteveen AB, Denys D, Olff M. Breathing biofeedback as an adjunct to exposure in cognitive behavioral therapy hastens the reduction of PTSD symptoms: a pilot study. Appl Psychophysiol Biofeedback. 2015 Mar;40(1):25-31. doi: 10.1007/s10484-015-9268-y. PMID 25750106
  • Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. PMID 21532953
  • Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. PMID 26606250
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID 11556941
  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. PMID 12964174

Identifiers

NCT: NCT07462312 · P_2025176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗