How can digital therapeutics more readily be brought into the hands of patients with serious mental illnesses?
Digital health technologies designed for serious mental illness (SMI) have the potential to close mental health treatment gaps.1-3 Upwards of 85% of individuals with SMI now use mobile phones as part of their daily routines, and over 60% own smartphones.4 A significant number of those with SMI have expressed interest in learning to use mobile applications to manage their moods, monitor mental health symptoms, and receive digital treatments.5
Academic researchers, startup companies, insurers, and the pharmaceutical industry are investing in development of digital health interventions for SMI, building on the opportunities afforded by increased technology use.6 These interventions may extend therapeutic contact beyond traditional in-person services and can be delivered in a cost-effective manner.7 It is prudent for providers to learn about new types of interventions emerging in the marketplace, how the development of these interventions differs from previously available tools, and ultimately how to think about selecting an intervention most appropriate for their patients.
The term digital health has commonly been used as a catch-all to encompass a wide variety of mobile health (mHealth) or telemental health interventions for SMI. Some, such as symptom trackers and those meant to provide patient education, are used to support wellness, but explicitly lack a clinical diagnostic, monitoring, or therapeutic component. Diagnostic and monitoring digital health tools for SMI exist and include tools such as ingestible medication sensors or remote patient monitoring systems that can help providers track patient engagement in clinical interventions.8,9 A relatively new term that is being used primarily in industry is “digital therapeutics” (DTx). Software classified as DTx are distinct in that they are specifically designed to deliver clinical interventions in a manner akin to a pharmacological intervention. They can be used as independent treatments or in conjunction with other interventions, such as psychotherapy.
The Gap From Science to Service
Health care has long been plagued by a science to service gap, where findings from research take more than 17 years to move into routine care.10,11 This is a particularly salient issue for the development of DTx, as the pace of technology advancement can result in a new intervention being outdated by the time it is available to the general public, even if delayed by only a few years. Partnerships between private digital health companies and stakeholders from the pharmaceutical and health insurance industries allow intervention developers to take advantage of marketing and regulatory knowledge that pharmaceutical and health insurance companies have cultivated in order to enhance distribution and reimbursement for their digital tools. However, they also highlight a tension between the desire to rapidly move DTx to market and the importance of carefully researching the effectiveness of an intervention prior to making it available for widespread use.
The vast majority of commercially available digital mental health tools have not completed the rigorous sequence of evaluation that academically-derived interventions go through before they are deemed effective. Although these interventions are readily available to the public, little is known about how well they actually work, or how best to use them in practice. Conversely, a wealth of information is known about digital health interventions developed in academic settings, but these interventions often lack a clear plan to for being disseminated to the public. Neither development pathway is innately the correct one; both have costs and benefits, and integration of lessons from each will help ensure the best products make it to patients in a timely fashion.
Consider FOCUS, a mobile health intervention for individuals with SMI that has been developed and tested extensively in grant-funded academic research since 2013.12 FOCUS offers both prompted and on-demand training to help individuals improve their management of auditory hallucinations, take their medications effectively, resolve sleep problems, enhance their social functioning, and enhance their mood. A clinician dashboard allows providers to view patient interactions and utilize this information to guide treatment planning. Trials of FOCUS indicate using the intervention leads to clinical improvements similar to in-person care, while also being considerably more engaging and cost-efficient. FOCUS has yet to be released broadly for commercial use, as it continues to undergo research studying how best to implement the tool in community mental health settings. The rigorous development and testing of FOCUS highlights the different pacing of grant-funded academic research and the move fast and break things mindset that is often employed (and required) in industry.
The US Food and Drug Administration (FDA) is exploring models of regulation for DTx as a means to provide oversight, potentially opening up new pathways for these interventions to translate into routine care more quickly. Recognizing that software-based interventions require updates in a fashion different than traditional medications, the FDA has been developing a precertification program in which individual companies, rather than individual interventions, can achieve approval based on the quality of their development process.13 The program takes into account that software products benefit from insight gained after release for broad use and aims to recognize developers who are able to monitor real-world efficacy. To date, 9 companies are participating in the precertification program, and indications are positive that the program results in a streamlined development pathway for DTx. If successful, regulatory frameworks similar to the FDA’s precertification program may help bring together development pathways that include both rapid pace and rigorous research.
Debate exists, however, about the extent to which regulation of DTx is necessary, and whether or not it will actually help patients access these tools. On one hand, regulation offers the opportunity to verify therapeutic benefits, assess risks, and may help these interventions to obtain inclusion on insurance formularies allowing for reimbursement.6 On the other, increased regulation is accompanied by high costs, delays in development, and may serve as an additional barrier to the use of digital tools among patients.
As a part of this debate, it is worth noting that the risk of adverse side-effects (which federal regulation is meant to help mitigate in new pharmacological interventions) is likely not the same for DTx. Whereas a new, unregulated medication may carry significant health consequences as a result of its biological effects, the risk of a misused DTx is considerably lower and is perhaps more closely related to other psychosocial approaches. Unless a clinician is engaging in unprofessional or unethical behavior, patients disengage rather than experience life-threatening physical side effects. Perhaps recognizing this distinction, the FDA temporarily relaxed its regulatory stance toward computerized behavioral therapies for psychiatric disorders during the COVID-19 pandemic—a move that may signal a wider recognition of the need for a differing regulatory approach when considering digital health versus pharmacological interventions.14
Selecting the Best DTx
While the future of digital therapeutic regulation remains in flux, clinicians should be aware of steps they can currently take to select the best digital interventions to use with their patients. One place for clinicians to start is by accessing online clearinghouses that include intervention reviews from a variety of perspectives (eg, clinicians, app developers, people with lived experience) and offer easy to understand breakdowns of interventions across a number of key features (eg, content quality, usability, security).15-19 These clearinghouses include digital health interventions beyond DTx, so clinicians should think carefully about the intention of each listed intervention and understand that some listed tools will not be providing any therapeutic interventions (eg, mood trackers) despite still being useful for care delivery. Developing and maintaining these online clearinghouses is also highly resource intensive, making it difficult for them to stay up to date.20 Clinicians should be aware that these resources may not include newly released tools and may have outdated information based on previous versions of interventions that have since been updated.
To help clinicians critically think about digital health interventions on their own, a workgroup of the American Psychiatric Association developed an easy-to-follow framework that guides clinicians through evaluating an intervention across 5 domains.21 The framework includes opinions from peers, clinicians, and informatics. When using the framework, clinicians are provided questions to help evaluate an intervention’s development background, privacy and safety standards, clinical foundation, usability, and therapeutic application. While not every question will be immediately easy for a clinician to answer, the framework helps shape one’s thinking about whether a particular intervention will be a good fit for practice, especially when limited research or information is available.
After identifying an intervention, clinicians should consider how they will present it to their patients. Following a shared decision-making model, the clinician and patient should take a balanced view of what to expect from DTx and how it may aid their recovery.22 Clinicians would benefit from having personal experience with an intervention to aid in this discussion and provide a detailed explanation of an intervention’s content, interface design, any potential concerns, and alternative options that may be worth considering.
If a patient chooses to use DTx, clinicians should take time to help them learn how to use the intervention, set goals about use, and discuss how the intervention’s content will integrate with the patient’s larger treatment plan.23 For example, if part of the patient’s treatment plan involves managing auditory hallucinations, then the patient should be introduced to how content of a selected intervention is intended to help with this goal.
In the end, the degree to which a clinician recommends, demonstrates effectiveness, and incorporates the content into ongoing care will go far in helping patients make the most out of using digital therapeutic in their care process.
Dr Tauscher works at the Behavioral Research in Technology and Engineering (BRiTE) Center, and in the Department of Psychiatry and Behavioral Sciences at the University of Washington, Seattle. Dr Ben-Zeev is a professor of psychiatry and behavioral sciences at the University of Washington, Director of the BRiTE Center, and Director of the mHealth for Mental Health Program.
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