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
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 insufficien...
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Frontiers Media S.A.
2025-02-01
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Online Access: | https://www.frontiersin.org/articles/10.3389/fdgth.2025.1503361/full |
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author | Rebecca Macy Flavio Somanji Flavio Somanji Oleksandr Sverdlov |
author_facet | Rebecca Macy Flavio Somanji Flavio Somanji Oleksandr Sverdlov |
author_sort | Rebecca Macy |
collection | DOAJ |
description | 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. |
format | Article |
id | doaj-art-aa68479e0b9b44358d046bdc7c537f4b |
institution | Kabale University |
issn | 2673-253X |
language | English |
publishDate | 2025-02-01 |
publisher | Frontiers Media S.A. |
record_format | Article |
series | Frontiers in Digital Health |
spelling | doaj-art-aa68479e0b9b44358d046bdc7c537f4b2025-02-11T06:59:04ZengFrontiers Media S.A.Frontiers in Digital Health2673-253X2025-02-01710.3389/fdgth.2025.15033611503361Designing and developing a prescription digital therapeutic for at-home heart rate variability biofeedback to support and enhance patient outcomes in post-traumatic stress disorder treatmentRebecca Macy0Flavio Somanji1Flavio Somanji2Oleksandr Sverdlov3School of Arts and Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, United StatesSchool of Healthcare Business and Technology, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, United StatesBiomedical Research, Novartis, Cambridge, MA, United StatesEarly Development Analytics, Novartis Pharmaceutical Corporation, East Hanover, NJ, United StatesPost-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.https://www.frontiersin.org/articles/10.3389/fdgth.2025.1503361/fullpost-traumatic stress disorder (PTSD)heart rate variability biofeedback (HRV-BFB)prescription digital therapeutic (PDT)digital therapeuticpsychological therapies |
spellingShingle | Rebecca Macy Flavio Somanji Flavio Somanji Oleksandr Sverdlov 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 Frontiers in Digital Health post-traumatic stress disorder (PTSD) heart rate variability biofeedback (HRV-BFB) prescription digital therapeutic (PDT) digital therapeutic psychological therapies |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | post-traumatic stress disorder (PTSD) heart rate variability biofeedback (HRV-BFB) prescription digital therapeutic (PDT) digital therapeutic psychological therapies |
url | https://www.frontiersin.org/articles/10.3389/fdgth.2025.1503361/full |
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