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HYPOTHESIS AND THEORY article
Front. Digit. Health
Sec. Digital Mental Health
Volume 7 - 2025 |
doi: 10.3389/fdgth.2025.1503361
This article is part of the Research Topic Advances in Understanding and Treating Post-Traumatic Stress Disorder View all 4 articles
Designing and developing a prescription digital therapeutic for at-home heart rate variability biofeedback to support and enhance patient outcomes in post-traumatic stress disorder treatment
Provisionally accepted- 1 Massachusetts College of Pharmacy and Health Sciences, Boston, United States
- 2 Novartis Institutes for BioMedical Research, Cambridge, Maryland, United States
- 3 Novartis (United States), East Hanover, United States
Post-traumatic stress disorder (PTSD) is a psychiatric condition producing considerable distress, dysfunction, and impairment in affected individuals. While various forms of psychotherapy are commonly utilized in PTSD treatment, the known neurological pathologies associated with PTSD are insufficiently addressed by these conventional approaches. Heart rate variability biofeedback (HRV-BFB) is a promising tool for correcting autonomic dysfunction in PTSD, with subsequent changes in clinically significant outcome measures. This paper outlines a systematic approach for the development, distribution, and implementation of a prescription at-home HRV-BFB digital therapeutic. We provide recommendations for evidence-generation strategies and propose appropriate regulatory pathways within existing frameworks. Widespread access to HRV-BFB could potentially reduce the distress, disability, and healthcare burden associated with PTSD. Promoting HRV-BFB as a primary intervention could also serve to reduce the stigma associated with 'mental' illness and increase health literacy regarding the neuroimmune impacts of psychosocial factors. These processes might in turn improve treatment-seeking, adherence, and supported self-management of these conditions.
Keywords: Post-Traumatic Stress Disorder (PTSD), heart rate variability biofeedback (HRV-BFB), prescription digital therapeutic (PDT), digital therapeutic, Psychological therapies
Received: 03 Oct 2024; Accepted: 23 Jan 2025.
Copyright: © 2025 Macy, Somanji and Sverdlov. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Oleksandr Sverdlov, Novartis (United States), East Hanover, United States
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