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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Main Authors: Rebecca Macy, Flavio Somanji, Oleksandr Sverdlov
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-02-01
Series:Frontiers in Digital Health
Subjects:
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.
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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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