Digital Biofeedback for Combat Veterans Diagnosed With PTSD

NCT07462312 | Recruiting

• 1 other identifier: P_2025176
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD - Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptom Severity (PCL-5 Total Score)

  The primary outcome is the change in the total score of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure; items are rated on a 0-4 point scale. Total score ranges from 0 to 80, where higher scores indicate greater symptom severity. PCL scores are expected to reduce in the intervention but not in the control groups.

  Baseline (Week 0) and Post-Intervention (Week 8).

Secondary Outcomes (6)

• Long term retention of Treatment Effects in the Intervention Group

  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)

  Baseline (Week 0) and Post-Intervention (Week 8)

• Change in Generalized Anxiety Symptoms (GAD-7)

  Baseline (Week 0) and Post-Intervention (Week 8)

• Change in Depressive Symptoms (PHQ-9)

  Baseline (Week 0), Post-Intervention (Week 8)

• Change in Psychological Resilience (CD-RISC-10)

  Baseline (Week 0), Post-Intervention (Week 8)

Other Outcomes (2)

• Weekly Change in PTSD Symptom Severity (PCL-6)

  Baseline, and weekly through Week 8

• Weekly Change in Psychological Wellbeing (ORS)

  Baseline, and weekly through Week 8

Study Arms (2)

Mental Gym® Immediate Intervention

ACTIVE COMPARATOR

Behavioral: Mental Gym® Biofeedback System

Delayed Intervention (Waitlist Control plus Garmin Watch)

NO INTERVENTION

Participants in this arm will initially serve as a no-intervention control group for a period of 8 weeks, during which they will continue with their Treatment as Usual (TAU). Following this 8-week period, they will receive the full 'Mental Gym®' intervention, identical to the experimental group, including the mobile application, and weekly sessions.

Interventions

Mental Gym® Biofeedback System BEHAVIORAL

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 NeuroBrave Sense mobile application, utilizing the provided wearable device ( Garmin watch) for real time biofeedback practices. Supplementary mental practice assignments are also delivered to participants via WhatsApp.

Mental Gym® Immediate Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: Male
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroBrave ltd.: lead

Study Sites (1)

NeuroBrave LTD - Remote Site

Jerusalem, Israel

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Morin CM,Belleville G,Bélanger L,Ivers H

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Lang AJ, Stein MB. An abbreviated PTSD checklist for use as a screening instrument in primary care. Behav Res Ther. 2005 May;43(5):585-94. doi: 10.1016/j.brat.2004.04.005.

  PMID: 15865914 BACKGROUND

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label behavioural/digital intervention. Due to the nature of the intervention, participants and study staff are not blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be recruited in two sequential waves (cohorts) of 40 participants each, for a total of 80 participants. Within each wave, participants will be randomly assigned (1:1) to either (a) the immediate intervention group or (b) the wait-list control (delayed intervention) group. The wait-list group will receive the same 8-week intervention after an initial 8-week waiting period. Outcomes will be assessed at baseline and after the first 8 weeks for between-group comparison; additional assessments will be conducted after the delayed group completes their intervention.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)