PTSD - Post Traumatic Stress DisorderNCT07462312
MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)
A study testing Mental Gym® Biofeedback System in people with PTSD - Post Traumatic Stress Disorder, run by NeuroBrave ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Mental Gym® Biofeedback System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Sep 2025to 14 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Sex: Male.
- Age: 18 to 50 Years.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of the MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD: A Randomized Controlled Trial
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
- Being tested
- Mental Gym® Biofeedback System
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Gym® Biofeedback SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental Gym® Immediate Intervention | Active comparator | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Post-Intervention (Week 8).
Secondary outcomes (6)
Long term retention of Treatment Effects in the Intervention Group
To assess long term improvement trajectories and retention, we will combine all intervention arm participants and conduct longitudinal within subjects analysis on primary and secondary change measures at post intervention, as well as 1.5-month Follow-up (Week 14), and 3-month Follow-up (Week 20). This analysis will also be used to identify subpopulations within our sample for whom the treatment was more or less beneficial.
We expect the clinical improvement to remain significant through the follow up time points.
Measured: 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)
change in resting heart rate variability (HRV) will be used as a physiological marker of autonomic regulation. HRV will be derived from inter-beat interval data collected during 5 min resting conditions during the first and the last group sessions using a wearable device and summarised using standard time-domain metrics (e.g., RMSSD). Higher HRV values and lower heart rate (HR) reflect greater parasympathetic activity and improved autonomic regulation. Resting HRV scores are expected to increase and resting HR to decrease in the intervention but not in the control groups.
Measured: Baseline (Week 0) and Post-Intervention (Week 8)
Change in Generalized Anxiety Symptoms (GAD-7)
Generalized anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item questionnaire (GAD-7), a validated self-report measure of anxiety severity. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Generalized anxiety symptoms are expected to reduce in the intervention but not in the control groups.
Measured: Baseline (Week 0) and Post-Intervention (Week 8)
Change in Depressive Symptoms (PHQ-9)
Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9), a validated self-report instrument assessing the severity of depressive symptoms over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Depressive symptoms are expected to reduce in the intervention but not in the control groups
Measured: Baseline (Week 0), Post-Intervention (Week 8)
Change in Psychological Resilience (CD-RISC-10)
Psychological resilience will be assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10), a validated self-report measure of perceived resilience and stress coping capacity. Total scores range from 0 to 40, with higher scores indicating greater resilience.Psychological resilience is expected to reduce in the intervention but not in the control groups.
Measured: Baseline (Week 0), Post-Intervention (Week 8)
Change in Sleep Quality (ISI)
Sleep quality will be measured using the Insomnia Severity Index (ISI), a validated self-report questionnaire assessing subjective sleep quality. The total SQS score will be used, with higher scores indicating poorer sleep quality. Sleep quality is expected to reduce in the intervention but not in the control groups.
Measured: Baseline (Week 0), Post-Intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Sep 2025
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBrave ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462312
- Sponsor's protocol ID
- P_2025176
- Status last verified
- May 2026
- First submitted
- 5 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36465089Schuman 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.
PubMed 36331685Tan 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.
PubMed 20680439Rosaura 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.
PubMed 25750106Morin 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.
PubMed 21532953Blevins 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.
PubMed 26606250Kroenke 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.
PubMed 11556941Connor 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.
PubMed 12964174Spitzer 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.
PubMed 16717171Lang 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.
PubMed 15865914
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of the MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07462312
- Acronym / sponsor ID
- P_2025176
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- NeuroBrave ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sex: Male.
- Age: 18 to 50 Years.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Gym® Biofeedback SystemThe 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. | Behavioural | Mental Gym® Immediate Intervention |
Primary outcome
Change in PTSD Symptom Severity (PCL-5 Total Score)
Time frame: Baseline (Week 0) and Post-Intervention (Week 8).
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.
6 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 36465089Cuyler 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.
- Background: PubMed 36331685Schuman 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.
- Background: PubMed 20680439Tan 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.
- Background: PubMed 25750106Rosaura 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.
- Background: PubMed 21532953Morin 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.
- Background: PubMed 26606250Blevins 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 12964174Connor 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 15865914Lang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Gym® Biofeedback System in people with PTSD - Post Traumatic Stress Disorder, run by NeuroBrave ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptom Severity (PCL-5 Total Score) (time frame: Baseline (Week 0) and Post-Intervention (Week 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462312, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.