PTSD - Post Traumatic Stress Disorder
Conditions
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.
Interventions
BEHAVIORALMental 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 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.
Sponsors
NeuroBrave ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptom Severity (PCL-5 Total Score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Change in Autonomic Regulation (Resting HRV) | Baseline (Week 0) and Post-Intervention (Week 8) | 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. |
| Change in Generalized Anxiety Symptoms (GAD-7) | Baseline (Week 0) and Post-Intervention (Week 8) | 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. |
| Change in Depressive Symptoms (PHQ-9) | Baseline (Week 0), Post-Intervention (Week 8) | 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 |
| Change in Psychological Resilience (CD-RISC-10) | Baseline (Week 0), Post-Intervention (Week 8) | 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. |
| Change in Sleep Quality (ISI) | Baseline (Week 0), Post-Intervention (Week 8) | 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. |
Countries
Israel
Outcome results
None listed