This article is sponsored by Otsuka America Pharmaceutical, Inc. The author is a paid consultant for Otsuka America Pharmaceutical, Inc.
Andrew D. Carlo, MD MPH, Senior Medical Director for Health System Integration at Meadows Mental Health Policy Institute and Health System Clinician, Department of Psychiatry and Behavioral Sciences at Northwestern University
With the growing number of behavioral health applications on the market, it’s likely one of your patients will ask for your recommendation on how such apps can be used to help manage their mental health symptoms, if it hasn’t already happened. As clinicians, we may not be prepared for such requests. Our training most likely did not cover the evaluation and use of digital technology as a part of patient care and formal practice guidelines do not yet exist.
In my own research on behavioral health apps, I’ve been astounded by the sheer number available – by one estimate, app stores contain as many as 20,000 different behavioral health-related apps . These products claim to address a wide array of behavioral health issues, but assessing their quality and applicability in practice is a challenge.
While there are many possible organizational frameworks, I see six main categories of behavioral health applications. These include wellness apps with a light-touch approach offering mindfulness and meditation activities; brain training and cognitive function apps; health coach and peer support apps; behavior and mood tracking tools; apps that offer computerized cognitive behavioral therapy (or other evidence-based treatments), and synchronous treatment apps that connect patients with live behavioral specialists.
Notably, a subset of apps called “digital therapeutics” are specifically designed to prevent, treat or manage a particular condition , such as substance use disorder and opioid use disorder while other digital therapeutics for other conditions like major depressive disorder are in clinical trials.
There is currently a small but growing number of digital therapeutic developers committed to conducting clinical trials and obtaining FDA authorization . Aside from these exceptions, most behavioral health apps are not evidence-based and there is often little to no regulatory oversight of product claims.
Despite these challenges, behavioral health apps still hold promise, but clinician awareness and involvement will likely be an important factor if patients are to benefit from such digital interventions.
Apps could increase access and reduce stigma
Presently, there are far too few behavioral health specialists to meet the nation’s growing need . Patients in rural areas often encounter long wait-times or must travel great distances to get care . Patients may also face high out-of-pocket costs to access treatments like psychotherapy . As a result, many patients living with behavioral health illnesses are unable to obtain adequate, timely and affordable treatment.
Adjunctive care provided through apps could help mitigate some of these workforce shortages and access challenges by extending the reach of specialists. For example, certain aspects of care could be automated to alleviate some of the need for synchronous communication with the patient, potentially extending the time between visits. Further, for patients living in healthcare deserts, digital tools may help them gain access to behavioral health providers through their devices or even begin a course of computerized cognitive behavioral therapy (CBT) while waiting for an in-person appointment.
Additionally, the fact that apps allow patients to seek support in private, at a time of their choosing, could help reduce the stigma sometimes associated with seeking out behavioral health treatment with local providers. This could increase the likelihood a patient will seek care because it is available when they perceive an acute need and with the relative anonymity of receiving care in the privacy of their own home.
Apps could enhance collaborative care
As a psychiatrist working in primary care and specialty settings, I embrace behavioral health apps, particularly when used within a collaborative care model. Collaborative care requires synchronized technological infrastructure and a digital treatment registry that tracks clinical outcomes over time. Apps, especially if linked to these systems, could streamline care by facilitating various components of treatment.
Specifically, behavioral health apps could be used for delivery of psychotherapy assignments or components, reporting mood and side effects, communication between clinicians and patients, and longitudinal outcome tracking, among many other possibilities. Additionally, by designating certain behavioral health apps as appropriate for use with certain patient populations, psychiatrists can help empower primary care physicians to offer tools for patients’ immediate use while waiting for specialist consults or referrals.
A need for evidence-based apps
Realizing the potential benefits of behavioral health apps will require clinicians to embrace and support their patients’ use of these digital tools. But, how can practitioners feel confident recommending apps when there’s so little guidance available? The lack of clinical data and regulation currently presents a formidable barrier to adoption as clinicians are rightfully hesitant to recommend unproven treatments.
There are some helpful websites that provide guidance by rating behavioral health apps on a variety of parameters including ease of use, technology integration, transparency and privacy, but there is a need for greater transparency about their safety and effectiveness. Fortunately, there is a regulatory pathway that app developers can pursue if they are committed to demonstrating safety and efficacy in a manner similar to prescription drugs. In fact, multiple such apps were authorized by the end of 2021 in various therapeutic areas, including mental health . These apps, known as ‘prescription digital therapeutics’ (PDTs), are indicated for specific patient populations, tested in clinical trials, and authorized by the FDA .
This regulatory process is critical in helping clinicians recognize which behavioral health apps have a supportive evidence base, resulting in greater confidence among clinicians in utilizing them in treatment. However, the costs and barriers to regulatory submission may discourage some smaller developers from seeking this validation. Shorter clinical trials and approval timelines may encourage more app developers to seek FDA authorization and increase the range of evidence-based digital therapeutic options available.
Regulatory involvement in this industry could also help increase patient trust in such treatments by introducing requirements that sensitive data remains well-protected and cannot be sold to third party entities — an extremely important factor when managing personal behavioral health information.
Affordability is another key consideration for patients. FDA-approved digital therapeutic apps should be accessible and eligible for insurance coverage, similar to other approved treatments. Coverage would also make it more likely that clinicians would embrace their use, as clinicians are often hesitant to recommend therapeutics that come with high costs to the patient.
Finally, if providers are to adopt such tools in practice, there’s a strong case to be made that their time associated with utilizing apps as part of patient care also be reimbursed. Just as there’s a billing code for giving a patient a PHQ-9 test, a measurement-based care code could also be applied to the use of FDA-approved PDTs. While progress is being made by CMS and the AMA towards the development of CPT codes for remote therapeutic monitoring of behavioral health data, patient education and onboarding associated with digital tools should also be reflected in billing codes.
In summary, the current number of FDA-approved PDTs is still quite small. Yet, the availability of these apps is quickly growing and entering the mental health field at a time of need. They have the potential to increase access to care, reduce stigma and provide new, innovative and adjunctive approaches to treatment that could benefit patients, while potentially relieving some of the pressure on providers’ time. While additional support structures and guidelines for adopting apps into clinical practice are still needed, I believe the future of digital therapeutics, and behavioral health apps more generally, in the delivery of mental health care could be extremely promising.
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April 2022 01US22EUP0001