Serious psychiatric disorders have risen sharply in prevalence in recent years, increasing the substantial public health burden represented by mood, anxiety and addictive disorders. In 2020, 2.7 million Americans reported past-year opioid use disorder (OUD), and 40.3 million had a substance use disorder, including alcohol or OUD. During the COVID-19 pandemic, a 25% increase in prevalence of anxiety and depression occurred worldwide, and opioid-associated deaths soared, exceeding 100,000 in the U.S. alone in 2021.
Technology-based interventions offer a new way to address this health crisis and the past several decades have ushered unprecedented advancements in both mobile application development and body sensor networks. This includes prescription digital therapeutics (PDTs), which in the context of expanding digital health solutions are software-based medicines that treat serious disease, as well as wearable, implantable and ingestible technologies to measure various aspects of mental health, substance use, and well-being related to health.
FDA-authorized PDTs have demonstrated evidence of clinical effectiveness, patient safety, and GMP quality. Despite the potential of PDTs to deliver validated behavioral therapies via a mobile device to improve long-term treatment outcomes, most clinicians are not familiar with the evidence base supporting these novel treatments. This issue will highlight the role of PDTs in generating clinical data from real-world evidence, health economics and outcomes research (HEOR), as well as randomized clinical trials supporting the role for PDTs in the treatment of psychiatric disorders.
Furthermore, smartphones, smart watches and fitness tracking tools have provided vast amounts of digital physiologic and behavioral data that enable providers to deliver personalized treatment based on an individual’s data and at a greater frequency than traditional care. These new digital biomarkers of mental health and substance use—prosody of smartphone use, biometric data surrounding behavioral events, geolocation and ambient environment conditions—provide an opportunity for social scientists, engineers and clinicians to advance mental health and substance use interventions antecedent to exacerbations of diagnoses or relapse during recovery.
This research topic provides an opportunity for multidisciplinary collaboration and exploration of the various facets of mental health, substance use, and well-being technologies and their ability to inform clinical decision-making and offer personalized approaches to treating mental health issues and supporting substance use recovery. We will invite authors with clinical, health economics, and/or digital technology expertise to submit original data or review articles relevant to this topic.
We encourage submissions on the following or related topics:
- Innovative technological solutions and applications in mental health and substance use disorder management
- Implementation Science strategies to bridge the gap between technological advances in research and real-world clinical deployment of these innovative technologies
- Regulatory evaluation of software as a medical device (SaMD), including therapeutic mechanisms of action in PDTs
- Real-world deployment and application of mental health and substance use technologies at a personal and community level, as well as evidence on health economics outcomes research (HEOR) for digital therapeutics
- Review of evidence base for behavioral therapies adapted to PDTs (e.g. cognitive-behavioral therapy, contingency management)
- Qualitative research that informs mental health or substance use disorder theories and acceptance models around personal mental health technology
- Identifying baseline and within-treatment predictors of key clinical outcomes, including early development and boundary condition exploration of technologies to detect changes in mental health symptoms or substance use status
- Diagnostic and demographic populations and subpopulations of interest in digital therapeutics
Topic Editor Maria Sullivan is employed by Vertex Pharmaceuticals. All other Topic Editors declare no competing interests with regard to the Research Topic subject.
Keywords:
Prescription Digital Therapeutics, Software as a Medical Device (SaMD), Wearable Technologies
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
Serious psychiatric disorders have risen sharply in prevalence in recent years, increasing the substantial public health burden represented by mood, anxiety and addictive disorders. In 2020, 2.7 million Americans reported past-year opioid use disorder (OUD), and 40.3 million had a substance use disorder, including alcohol or OUD. During the COVID-19 pandemic, a 25% increase in prevalence of anxiety and depression occurred worldwide, and opioid-associated deaths soared, exceeding 100,000 in the U.S. alone in 2021.
Technology-based interventions offer a new way to address this health crisis and the past several decades have ushered unprecedented advancements in both mobile application development and body sensor networks. This includes prescription digital therapeutics (PDTs), which in the context of expanding digital health solutions are software-based medicines that treat serious disease, as well as wearable, implantable and ingestible technologies to measure various aspects of mental health, substance use, and well-being related to health.
FDA-authorized PDTs have demonstrated evidence of clinical effectiveness, patient safety, and GMP quality. Despite the potential of PDTs to deliver validated behavioral therapies via a mobile device to improve long-term treatment outcomes, most clinicians are not familiar with the evidence base supporting these novel treatments. This issue will highlight the role of PDTs in generating clinical data from real-world evidence, health economics and outcomes research (HEOR), as well as randomized clinical trials supporting the role for PDTs in the treatment of psychiatric disorders.
Furthermore, smartphones, smart watches and fitness tracking tools have provided vast amounts of digital physiologic and behavioral data that enable providers to deliver personalized treatment based on an individual’s data and at a greater frequency than traditional care. These new digital biomarkers of mental health and substance use—prosody of smartphone use, biometric data surrounding behavioral events, geolocation and ambient environment conditions—provide an opportunity for social scientists, engineers and clinicians to advance mental health and substance use interventions antecedent to exacerbations of diagnoses or relapse during recovery.
This research topic provides an opportunity for multidisciplinary collaboration and exploration of the various facets of mental health, substance use, and well-being technologies and their ability to inform clinical decision-making and offer personalized approaches to treating mental health issues and supporting substance use recovery. We will invite authors with clinical, health economics, and/or digital technology expertise to submit original data or review articles relevant to this topic.
We encourage submissions on the following or related topics:
- Innovative technological solutions and applications in mental health and substance use disorder management
- Implementation Science strategies to bridge the gap between technological advances in research and real-world clinical deployment of these innovative technologies
- Regulatory evaluation of software as a medical device (SaMD), including therapeutic mechanisms of action in PDTs
- Real-world deployment and application of mental health and substance use technologies at a personal and community level, as well as evidence on health economics outcomes research (HEOR) for digital therapeutics
- Review of evidence base for behavioral therapies adapted to PDTs (e.g. cognitive-behavioral therapy, contingency management)
- Qualitative research that informs mental health or substance use disorder theories and acceptance models around personal mental health technology
- Identifying baseline and within-treatment predictors of key clinical outcomes, including early development and boundary condition exploration of technologies to detect changes in mental health symptoms or substance use status
- Diagnostic and demographic populations and subpopulations of interest in digital therapeutics
Topic Editor Maria Sullivan is employed by Vertex Pharmaceuticals. All other Topic Editors declare no competing interests with regard to the Research Topic subject.
Keywords:
Prescription Digital Therapeutics, Software as a Medical Device (SaMD), Wearable Technologies
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.