Speaking of Psychology - Digital therapeutics and mental health apps, with Vaile Wright, PhD

Episode Date: June 7, 2023

As the U.S. struggles with a shortage of mental health providers, advocates say that digital therapeutics – evidence-based mental health treatments delivered via app -- could provide an important tool to expand access to mental health care. Vaile Wright, PhD, a clinical psychologist and senior director of healthcare innovation at the American Psychological Association, talks about how digital therapeutics work, how they’re regulated, how they differ from other mental health and wellness apps, the kinds of mental and behavioral health conditions they can treat, and the role they might play in mental health treatment in the future. For transcripts, links and more information, please visit the Speaking of Psychology Homepage. Learn more about your ad choices. Visit megaphone.fm/adchoices

Over the past six years, the U.S. Food and Drug Administration has approved dozens of apps designed to treat health problems, including mental health issues such as post-traumatic stress disorder, chronic insomnia, and substance use disorders. As our nation struggles with a shortage of mental health providers, advocates say that these apps, called digital therapeutics, could provide an important tool to get mental health treatment to people who might not otherwise be able to access it. But many questions remain about how these treatments will be regulated, prescribed, paid for, and accessed. Today we're going to explore some of those questions. What are digital therapeutics? How do they work? How do they differ from the hundreds of other unregulated mental health and wellness apps in app stores? What kinds of mental health conditions can they treat? Who regulates digital therapeutics?

Who prescribes them and who pays for them? How strong is the evidence that they work? and what role might they play in expanding access to mental health care? Welcome to Speaking of Psychology, the flagship podcast of the American Psychological Association that examines the links between psychological science and everyday life. I'm Kim Mills. My guest today is Dr. Vale Wright, a clinical psychologist and the Senior Director of Healthcare Innovation at the American Psychological Association.

In that role, she focuses on developing strategies to leverage technical technology, and data to address issues within health care, including improving access to care, measuring care, and optimizing treatment delivery. She's also a leading spokesperson for APA and has been interviewed by TV, radio, print, and online media, including The Washington Post, the New York Times, NPR, and many more on topics including stress, trauma, telehealth, and technology. Thank you for joining me today, Dr. Wright. Thanks, Kim. I'm excited to be here. And because we've known each other for years, I'm going to call you Veil.

I appreciate that. Let's start with an overview of what we mean when we refer to digital therapeutics. What are digital therapeutics and what's the difference between them and the many other mental health and wellness apps that anyone might come across in app stores like Apple or Google Play? Yeah, digital therapeutics are software programs that you can access on your phone, your tablet, your computer, and they deliver evidence-based. and validated psychological treatments to treat things like depression or anxiety and a variety of different mental health disorders. I think where it gets confusing is that these are not direct-to-consumer apps that you can download off the app store of your choice. Those apps like Calm or Headspace are designed to teach coping skills, such as mindfulness meditation or stress management, but they don't treat disorders like depression or anxiety.

And that's what digital therapeutics are really designed to do, to treat. treat disorders. So how do digital therapeutics work? Are they just automated versions of the type of therapies that someone might engage in with a psychologist or another mental health provider? Are they actually artificial intelligence versions of an actual psychotherapist, or do they work differently? So digital therapeutics have taken well-established treatments, such as cognitive behavioral therapy or CBT, and digitize them. And honestly, this constant isn't new. Online versions of CBT have existed for a while. But what is new is the sophistication of the technology, like you just mentioned. So they use AI, including machine learning and natural language processing,

to personalize the treatment to the patient. So if I can give an example, let's say you are somebody who's interested in using CBT for insomnia. And your chronic insomnia issue is that you have problems falling asleep, but not necessarily staying asleep or waking up too early. And so these AI-driven devices can actually personalize the treatment and the interventions that they offer you based on what it is that you're presenting. So they would help you with how to fall asleep, but wouldn't necessarily give you skills on how to stay to sleep because that's not what you need. So that's really what makes them unique. What other mental health conditions have digital therapeutics been approved to treat up until now? So there have been a few that have gone through the formal FDA clearance process for mental health disorders like substance use, anxiety.

and trauma, ADHD, and you're also seeing them expand into more physical health conditions like irritable bowel syndrome and pain disorders. So actual psychotherapy can help with irritable bowel disorders, for example. I mean, that strikes me as almost miraculous. Yeah, there are a lot of ways in which predominantly CBT, but other types of psychological interventions like biofeedback, can actually address physical health conditions instead of using traditional pharmaceuticals, which may have a lot of negative side effects. So if we can find that, you know, psychological interventions are just as effective, if not more effective,

then this is another really great way to get these types of interventions into the hands of the patients that need them. How strong is the evidence that they work and how do they compare to traditional in-person therapy or even teletherapy? Yeah, we've seen really robust findings from randomized control trials, that these products, digital therapeutics, are effective and appear to be as effective as in-person therapy. And we've even seen some studies that suggest that digital therapeutists can deliver a treatment intervention in fewer sessions than in-person therapy. So there are potential cost benefits there as well as freeing up time for providers to be able to see more patients. But all that said, providers play a really important role in the use of digital therapeutic. So it's not going to replace them in any way, but instead, providers help determine whether

a digital therapeutic is appropriate for a patient. They help them set it up and learn how to use it. And then providers need to monitor the treatment over time to make sure the outcomes are what we hope they are, that utilization is robust so that we can be sure that these things are working the way they're supposed to in that a patient doesn't actually need a higher level of care because they're in crisis. And in fact, a recent meta-analysis came out that showed that when these types of digital mental health interventions have provider involvement, they're actually more effective. So we think it's a pretty critical component.

Now, what are they like? I mean, if I were to access one of these digital therapeutics, what would I be hearing when I turned on my phone, put in my earbuds and, you know, turned it on? So the technology differs, depending on the actual therapeutics. Some are a bit more robust than others. but many have some sort of chat bot type feature or an avatar that would interact with you in real time and would again tailor the treatment based on what your responses are to various prompts. And these treatment interventions and the scripts that the chatbot uses, they've been designed by experts in the field.

So we know that they're based on the best evidenced psychological treatments that exist. And then you would use them on a weekly basis, maybe, you know, every five days or so as you go through the treatment protocol kind of at your own pace. But ideally, you know, often enough that you're seeing the real benefits. But you have that convenience of doing it from your own home as opposed to having to go into a more traditional sort of therapy office on a weekly basis. And then when the therapist you're working with is interacting with you, I assume that he or she is getting some kind of data from the app and then what? I mean, is there some interpretation and modification as you go along? Yeah, absolutely.

Again, it will depend a little bit. It might differ a bit depending on the provider. But ideally, the provider is, you know, tracking the outcome data that's coming through the device. So, you know, on a weekly basis, the patient may take a brief survey, just checking to see how their symptoms are. And if they're improving, there are usually, you know, messaging features so the provider can provide asynchronous messages to the patient to let them know how they're doing. Or you can schedule, you know, maybe every four weeks you schedule a brief phone call to just check in, see how it's going, make sure it's still working, and you still have that more kind of personal face-to-face or, you know, on the telephone kind of touch. So I think there's a variety of different ways that the patient still feels connected to the provider, even though they're receiving an evidence-based treatment in their own home. What's the regulatory process for approving these?

I mentioned earlier that some have been cleared by the FDA. Does the FDA regulate them in the same way that they regulate prescription drugs or medical devices? Currently, the process is very similar. So the FDA is tasked with regulating the space because these devices make claims that they diagnose, treat, or cure a medical disorder. And those words are really critical. You know, diagnose, treat, or cure. That's the part that makes it fall under the FDA. And the FDA primarily focuses on two things.

The first is efficacy. So device makers need to demonstrate via randomized control trials and other types of research that their product actually works. And secondly, they focus on safety. And so that's how we get to the regulatory process in that the FDA has two pathways. One is they can determine that a device is relatively safe, safe enough that you don't need a provider involved. And so they distribute those over the counter. Or you can have devices that do require a lot of. of provider involvement. And then these devices need to be prescribed or ordered by an appropriate,

you know, medical provider. So in the case of mental health digital therapeutics, that could be a psychologist, a social worker, or it could be a primary care physician or another specialty type doctor. So the prescription authority sounds like it's pretty broad at this point. You don't need an MD, for example, as you might with drugs or in the case of psychologists who provide, they have to go to school and get extra certification. Doesn't sound like that's the case here. There's a lot of confusion, I would argue, around the regulatory space because the FDA only has two pathways. And one of those pathways is deemed, quote unquote, prescription. And so we all, I think,

just immediately go to this idea of it's the same as prescribing pharmaceuticals. We don't think that that is the case. When the FDA says prescribe or order a software, what they're really wanting is for the device maker to determine in their labeling who is appropriate to prescribe or order. And because these types of mental health digital therapeutics use psychological treatments that are within the scope of practice of a variety of different providers like psychologists, you know, as long as the device maker includes them in the label, we believe that psychologists are able to prescribe and or order these products when appropriate with their patients. Are digital therapeutics covered by insurance right now?

And if not, what's the outlook for that? Currently, there's no universal way for reimbursing digital therapeutics within our traditional healthcare system. And so, you know, you have kind of a variety of different ways that individuals might access these products. One is you have certain systems like the VA or Kaiser Permanente who have incorporated digital mental health within their offerings to their patients within their various systems. In other sorts of cases, you might have these device companies having made contracts with different employers so that if you're an employee of that company, you can access the product through your benefit portal.

And so I think ideally we want to get to a place where we have broader access because we have more traditional reimbursement, but we're just not quite there yet. In the long term, how do you think digital therapeutics will fit into the landscape of how people access mental health treatment? Will they replace in-person therapy, do you think, at some point? I don't think that they'll replace in-person therapy. I think there's always going to be the need for high-touch levels of care from person to person on a weekly sort of 45-minute psychotherapy basis. But I also think that to address the mental health crisis, we need to be thinking more innovatively, and we need to break away from the status quo of how we've always done things. And I think digital therapeutics can be an important tool for providers. to address access and efficiency and care.

And so I think it's going to look a few different ways. One example would be to address wait lists. So we know that wait lists are incredibly long right now. So maybe you're a parent and your child has recently been diagnosed with ADHD. You want them to have medication and psychotherapy. But the psychotherapy wait list is six months. Could you use a digital therapeutic design for ADHD in that meantime while you're waiting on that wait list? So that's one example.

Another might be, you know, individuals living in rural areas that don't have a lot of access to care. You know, you see your primary care physician, you're reporting chronic insomnia. You don't want to take medications for a variety of reasons, including addiction and side effects. But there isn't any provider that does CBT for insomnia in your area. So could you use a digital therapeutic design for that to address that space? And my last example will just be, I think there's a lot of room to incorporate patient preference. within our health care systems. So the example I always give is, you know,

maybe you have somebody who is been diagnosed with cancer and they're receiving weekly, you know, oncology visits to treat it, but they have anxiety on top of it, which wouldn't be sat surprising, but let's say they don't want to come back on a weekly basis in addition to that cancer treatment just to see another therapist. Could you use a digital therapeutic that they could take home with them that a provider monitors, you know, from afar,

in order to really address the mental health needs and the physical health needs of people in this country. So I think there's a lot of really interesting opportunities, as long as we can address the barriers to scalability and get these into the hands of the people that need them. How aware is the average provider of the existence of digital therapeutics in order to prescribe them? I mean, as a consumer, I wouldn't really be able to just go someplace and find them, right? I mean, they're not in the app store. So if my psychologist doesn't know about these digital therapeutics, how do I get that information? I think that lack of knowledge about this space is the number one barrier to getting broader access to care. I think that, you know, psychologists as well as other providers just aren't that aware of these new products, even though we've seen a surge in them since the start of the pandemic.

I think because they haven't been incorporated into traditional health care, we're just not seeing. seeing as much usage as certainly we would like to see. So, you know, as part of what we're doing, including this podcast, is we're really trying to get education out to both consumers but also providers, that these are new opportunities, new tools, and to seek them out. So I think that, you know, APA is working really hard to address the regulatory barriers and the reimbursement barriers. And ideally, when we solve both of those, our next step is going to have to be how do we help providers know how to use these in their practice? How do they incorporate them into their workflow in a way that is assistive and not, you know, just another administrative burden? So I think there's a lot of work to be done. But I'm excited that APA is at the forefront of doing a lot of this work.

Are the companies that create these digital therapeutics, are they using the same marketing techniques that, say, the pharmaceutical industry uses where there are. actual sales reps who go and visit doctors? I don't think that most of the companies are at that space yet. I think that they are still, you know, trying to determine what regulatory path they want to work, go down. How can they continue to get the research that they need in order to demonstrate the efficacy of their products? And so, and how do we, how do they get them paid for? I do see them likely moving in that path in the future, although I would also argue that the more that we equate traditional therapeutics to the pharmaceutical company, the more confusion I think we end up having. So I think it's important to really consider these as therapy tools akin to, you know, traditional psychotherapy models that we're accustomed to. And so we need to pay for them similarly.

and we need to just be talking about them in a very similar manner. But in the meantime, let's say that I'm interested in using one of these digital therapeutics, what is the average cost if I'm going to have to pay out of my pocket because my insurance doesn't cover it? What should I expect to pay? Yeah, the cost really varies for companies that are charging. You know, it can be anywhere from $500 to $1,500 for the device for the software itself. And generally, it also includes some sort of monthly. kind of subscription cost.

Because a lot of these companies are just trying to get their products out to the people, some of them actually give them away from free at this point. So, you know, I think there's a really wide variety on the business models and the processes and the distribution model. And again, that variety causes a lot of challenges. If we had a bit more universality, I think we will achieve better scalability and actual access to these products. Let's talk a little more broadly about mental health apps, including the ones that are not digital therapeutics, are not prescribed, but anyone can access in an app store.

How can consumers evaluate these apps? Honestly, it is not easy. You really have to do the research, and you need to go to the company's website and search for published research studies that show that the products are effective. You need to look to see if they have mental health professionals and experts, either working for the company, helping to design the app and or that serve on different advisory committees like a scientific advisory committee. These are not often things you're going to find on the app store itself. So you really do have to kind of do your own research. And just as importantly, you need to seek out what their privacy policy says and determine what type of data they're collecting from you. how they're using that data and what they're going to do with it.

Because we've had some really high profile cases lately of different online or app companies, selling your personal information to advertisers. And so obviously, that's not something you want. But it also puts you at risk for identity theft and other types of challenges. So it's important to do your due diligence, to do your homework, to not just look at the rating on the app store and use that as your way to determine and whether or not this is a good tool for you. So are there different controls then around digital therapeutics that are FDA-approved?

Would they be covered by HIPAA, which makes your information confidential? Absolutely. That's a really, really important point. So because digital therapeutics, you know, again, purport to diagnose, treat or cure a mental disorder, they are bound by certain privacy laws like HIPAA. And so they have to demonstrate to the FDA and to their consumers and providers that they are going the extra mile to protect personal health information. Apps from the app store have no obligation to do that. They are not bound by HIPAA. And so they can take your personal health information and kind of do whatever they want with it.

There isn't any regulatory oversight of the directed consumer, the wellness apps, the lifestyle apps. And so that's something also to keep in mind. So there's nobody really making determinations whether those types of apps are effective or whether they are safe. So what's APA's role in the promulgation of digital apps? Is APA considering approving apps or giving a seal of like a good housekeeping seal of approval for apps? Is there any role that you are playing as you're reviewing some of these therapeutics right now? So in the wellness and lifestyle app space, you know, our role has really been to help inform consumers on what to look for if they're looking to use one of those products. And we've also have historically had a column within our office called Let's Get Technical.

That's reviewed different apps in different spaces. We also often point individuals to other groups that have engaged in sort of evaluation of these apps. But it's a really challenging resource-intensive space. to be because these apps can change all the time. And so once you reviewed it and maybe you've given it your seal of approval, they could turn around and change their privacy policy, you know, and then it might not meet that seal of approval. So that's really challenging.

When it comes to digital therapeutics, we've really been working closely with a variety of different device companies to help them navigate this regulatory reimbursement space. Because I think if we can all get on the same page and work together, then we're much more likely to have a big impact on solving this mental health crisis. Because again, these digital therapeutics, they use what we already know works to reach more and more people to help them get the psychological treatment that they need. And so I think, you know, that's really where we spent a lot of our focus is in that space because we think it can have the biggest impact. So to wrap up, what would you say are the biggest challenges that the field of digital

therapeutics faces right now? I think the biggest challenge is lack of understanding of what these are and what they aren't. I think they often get conflated with wellness apps, which, again, might have a role in being helpful, but we know that they're not used very often. They're downloaded once and then sort of abandoned. And so helping people really understand how digital therapeutics are different, how they're meant to provide a different service, and how we have a higher expectation in terms of they're being able to demonstrate effectiveness and safety.

I think if we can get people to really understand that, then we can make better inroads on the barriers around regulation and around reimbursement. People just don't understand what they are. And when we don't understand what something is, we get hesitant. And that's what we're really seeing right now. We're seeing a lack of urgency by policymakers on moving forward and really figuring out solutions to incorporate these into health care. But we've got to do it.

We've got to think creatively and innovatively to address them into health crisis. We can't just keep doing the same old thing and expect people to get better. Well, Vail, I want to thank you for joining me today. I think the work you're doing is really inspiring and important. And I wish you a great deal of luck and success.

Thanks, Kim. It was great talking with you. You can find previous episodes of Speaking of Psychology on our website at www. www. speakingof psychology.org or on Apple, Stitcher, YouTube, or wherever you get your favorite podcasts. If you have comments or ideas for future podcasts, you can email us at speaking of psychology at APA.org.

Speaking of psychology is produced by Lee Weinerman. Our sound editor is Chris Condihan. Thank you for listening for the American Psychological Association. I'm Kim Mills.