IN MENTAL HEALTH

Prescription digital therapeutics bridge the gap between treatment and everyday life

Man walking on a partial mobile phone bridge

Prescription digital therapeutics (PDTs) are software-based solutions prescribed by HCPs that deliver FDA-cleared, evidence-based therapy to patients through devices such as a smartphone or tablet^1,2

The revolution of PDTs to deliver validated neurobehavioral techniques in mental health has begun. Treatments delivered via PDT have been clinically proven to help treat, manage, and prevent a spectrum of disease and disorders, including mental health conditions.^1,2PDTs have been proven efficacious in the real world for a range of behavioral health conditions, including ADHD, anxiety, depression, insomnia, PTSD, and substance abuse.³

PDTs are distinctly different from health and wellness apps because they are¹:

Rigorously studied for safety and efficacy in randomized clinical trials

Cleared by the FDA*

Prescribed by health care providers

*While drugs are “approved” by the FDA, PDTs are FDA “authorized” or cleared as a software as a medical device (SaMD). All of them are required to have clinical trials as part of the FDA authorization.⁴

Three different ways to use PDTs^5,6

Expand All

Individual, and in some cases, independent of other therapies. Can also be used at the same time as other treatments.

Concomitant with pharmacological intervention.

Works in combination with pharmacological and nonpharmacological interventions by complementing self-management of condition and related health care factors.

PDTs are a treatment modality that can be incorporated into a multimodal treatment approach and may be effective independently or as an adjunct to medication, devices, or psychotherapy.² This offers the potential to increase access to care, expand treatment options, and improve health equity¹

NOTES:
1. If you need more space to make the copy fit, then you can remove the image.
2. superscript the 1,2

Move this way to find out more

Addressing the gaps in mental health:
Getting patients care where and when they need it^1,2

With PDTs, patients with mental health conditions can access treatment anytime, anyplace,
which can help relieve the barriers to comprehensive care, such as:

Stigma¹

Poor access to care^1,2

Provider shortages¹

Three squiggly arrows crossing each other

Complex health systems¹

Empowering patients to take an active role in their care^2,5,7-9

Some of the ways PDTs empower patients in mental health include:

Self-directed training sessions⁵
Treatment reminders, education, and individualized dosing calculations⁷
Data capture and health information analyzation²
Behavior-modifying game play⁸
Progress tracking and goal setting/achievement⁹

Because people living with mental health conditions can face many challenges accessing care,¹ evidence-based treatment, including validated neurobehavioral techniques, delivered via PDTs may be an effective way to get them the help and support they need, on demand

Keep the momentum going

PDTs are designed to be convenient and user friendly, expanding accessibility to evidence-based treatments anytime, anywhere^1,2

How can PDTs fit into your treatment approach?

An extension of care for patients between visits⁵

Incorporating PDTs can enable healthcare providers and patients to extend their current practices between visits, enhancing patient care and outcomes.

Effective independently or as an adjunct to medications, devices, or psychotherapy^1,2

Offering the potential to increase access to care, expand treatment options, and improve health equity.

Expand accessibility to evidence-based treatments for certain disease states^1,5

Working in concert with remote education, assessment, and telehealth visits to further enable a holistic approach to care.

Relatively low risk of adverse events^5,10,11

People treated with PDTs are less likely to experience adverse events or drug interactions.

PDT promo for designed to be convenient and user friendly

Designed to be convenient and user friendly^1,2

Patients can discreetly access validated neurobehavioral techniques delivered by PDTs anyplace, anytime.

Clinical trials are currently underway to explore the benefit of using PDTs for mental health conditions—paving the way for these technologies to help even more people receive the care they need to lead more fulfilling lives.³

At Boehringer Ingelheim, we are championing every
mind for generations with innovative solutions in
mental health

Our commitment to changing the landscape of mental health care covers
a range of serious mental health conditions. Boehringer Ingelheim is
proud to partner with Click Therapeutics to investigate the applications of
PDTs in addressing gaps in care for those with serious mental health
conditions.

With PDTs, we are bringing innovative treatment modalities to people
living with serious mental health conditions so that they can create
more meaningful connections to their lives, loved ones, and society.

References

Brezing CA, Brixner DI. The rise of prescription digital therapeutics in behavioral health. Adv Ther. 2022;39(12):5301-5306. doi:10.1007/s12325-022-02320-0
Dang A, Arora D, Rane P. Role of digital therapeutics and the changing future of healthcare. J Family Med Prim Care. 2020;9(5):2207-2213. doi:10.4103/jfmpc.jfmpc_105_20
What is digital health? American Psychological Association. Updated December 2023. Accessed March 28, 2024. https://www.apa.org/practice/digital-therapeutics-mobile-health
Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and prescription digital therapeutics: evolving with the technologies they regulate. Front Digit Health. 2023;5:1086219. doi:10.3389/fdgth.2023.1086219
Liesch J, Murphy D. Digital Therapeutics 101: An Introduction and Overview. Blue Matter Consulting. Published 2021. Accessed March 13, 2024. https://bluematterconsulting.com/wp-content/uploads/2021/06/Digital-Therapeutics-101-eBook-06-2021.pdf
Kutz J, Culjat M, Averback J, Fujimoto C, Pecoraro J. Harnessing the commercial promise of prescription drug use-related software (PDURS). Eversana. March 7, 2024. Accessed April 30, 2024. https://www.eversana.com/insights/harnessing-pdurs/
Unnikrishnan AG, Viswanathan V, Zhou FL, et al. Impact of My Dose Coach app frequency of use on clinical outcomes in type 2 diabetes. Diabetes Ther. 2022;13(5):983-993. doi:10.1007/s13300-022-01245-9
EndeavorRx. Instructions for use. Akili Interactive Labs, Inc.; 2023.
Jacobson NC, Kowatsch T, Marsch LA. Digital therapeutics for mental health and addiction: The state of the science and vision for the future. Elsevier Inc.; 2022.
Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med. 2023;6(1):38. doi:10.1038/s41746-023-00777-z
Lutz J, Offidani E, Taraboanta L, Lakhan SE, Campellone TR. Appropriate controls for digital therapeutic clinical trials: a narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content. Front Digit Health. 2022;4:823977. doi:10.3389/fdgth.2022.823977

Prescription digital therapeutics bridge the gap between treatment and everyday life

Prescription digital therapeutics (PDTs) are software-based solutions prescribed by HCPs that deliver FDA-cleared, evidence-based therapy to patients through devices such as a smartphone or tablet1,2

PDTs are distinctly different from health and wellness apps because they are1:

Rigorously studied for safety and efficacy in randomized clinical trials

Cleared by the FDA*

Prescribed by health care providers

Three different ways to use PDTs5,6

Standalone

Adjunctive

Combination

PDTs are a treatment modality that can be incorporated into a multimodal treatment approach and may be effective independently or as an adjunct to medication, devices, or psychotherapy.2 This offers the potential to increase access to care, expand treatment options, and improve health equity1

Addressing the gaps in mental health: Getting patients care where and when they need it1,2

Stigma1

Poor access to care1,2

Provider shortages1

Complex health systems1

Empowering patients to take an active role in their care2,5,7-9

Because people living with mental health conditions can face many challenges accessing care,1 evidence-based treatment, including validated neurobehavioral techniques, delivered via PDTs may be an effective way to get them the help and support they need, on demand

PDTs are designed to be convenient and user friendly, expanding accessibility to evidence-based treatments anytime, anywhere1,2