[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NeuroBrave ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100628490","digital-biofeedback-for-combat-veterans-diagnosed-with-ptsd-100628490",false,"NCT07462312","Digital Biofeedback for Combat Veterans Diagnosed With PTSD","Evaluating the Efficacy of the \"Mental Gym®\" Biofeedback-Based Intervention for Combat Veterans Diagnosed With PTSD: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Sex: Male\n* Age: 18 Years and older.\n* Diagnosis: Clinical diagnosis of Posttraumatic Stress Disorder (PTSD) with mild to moderate-severe symptom intensity.\n* Symptom Severity: A PCL-5 total score of up to 60 at screening.\n* Traumatic Event: PTSD diagnosis based on a traumatic event that occurred in the year 2000 or later.\n* Service Eligibility: Eligibility for Ministry of Defense (MOD) rehabilitation services.\n* Technical Proficiency: Ability to use a smartphone and a wearable device.\n\nExclusion Criteria:\n\n* High Symptom Severity: PTSD symptom severity exceeding the moderate-severe range (PCL-5 score \\> 60) or requiring more intensive clinical intervention.\n* Psychiatric Stability: Acute psychiatric instability, including active suicidal ideation or psychosis.\n* Medication: Current use of Olanzapine (Zyprexa) or Quetiapine (Seroquel).\n* Sleep Disturbances: Severe sleep impairment (score \\> 7 on the The Insomnia Severity Index).\n* Functional Impairment: Severe impairment in concentration or cognitive processing that precludes the use of digital biofeedback tools.","MALE","18 Years","50 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"PTSD - Post Traumatic Stress Disorder","RECRUITING","2026-03-05",{"date":31,"type":32},"2026-03-10","ACTUAL",{"date":34,"type":32},"2025-09-15",{"date":36,"type":21},"2026-09-30",{"name":38,"class":39},"NeuroBrave ltd.","INDUSTRY",""]