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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mental Gym® Immediate Intervention | Active Comparator |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Change in PTSD Symptom Severity (PCL-6) | The PTSD Checklist - 6-item version (PCL-6) is a validated self-report screening tool for Post-Traumatic Stress Disorder. It assesses symptoms such as intrusive thoughts, avoidance, and hyperarousal. Total scores range from 6 to 30, with higher scores indicate greater symptom severity. A decrease in scores over time represents clinical improvement. | Baseline, and weekly through Week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroBrave LTD - Remote Site | Recruiting | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36465089 | Background | 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. | |
| 36331685 | 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. |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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.
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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.
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| 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. | 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. | 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 | 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. | 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. | Baseline (Week 0), Post-Intervention (Week 8) |
| Weekly Change in Psychological Wellbeing (ORS) | The Outcome Rating Scale (ORS) is a 4-item visual analogue scale designed to measure change in three areas of client functioning: individual (personal well-being), interpersonal (family/close relationships), and social (work/school/friendships), as well as overall well-being. Total scores range from 0 to 40, with higher scores indicate better psychological wellbeing and functioning. An increase in scores over time represents improvement. | Baseline, and weekly through Week 8 |
| 20680439 | 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. |
| 25750106 | 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. |
| 21532953 | Background | 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. |
| 26606250 | 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. |
| 11556941 | 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. |
| 12964174 | 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. |
| 16717171 | 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. |
| 15865914 | 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. |