Your Patient Shows You an App. Now What?

Jilly Carter: Hello, and a very warm welcome to the first in a series of online conversations about the rise and rise of mental health apps in clinical settings. Our discussion today is going to focus on how these apps are currently being used in treatment plans, the potential for clinically validated and regulated forms of these apps known as digital therapeutics, and we'll also touch on a subset of these prescription digital therapeutics. My name's Jilly Carter. I'm an ex-journalist, and I've worked for various outlets in television and radio, such as the BBC, Reuters, and WRAL. I'm delighted to be here, and I'm delighted to introduce my two distinguished guests today.

The first is David Mohr, Ph.D. Dr. Mohr's work focuses on the design and implementation of digital mental health treatments. He's focused on those that fit into the fabric of people's lives and ones that can be sustainably implemented in real-world settings. His research integrates user-centered design processes to incorporate stakeholder input into the creation and evaluation of digital mental health services. He's also exploring methods of gathering and incorporating sensor data from devices such as smartphones to identify behaviors, states, and environmental conditions. He's committed to using these data to design digital mental health tools that are more effective and therefore easier for people to use.

My second guest is Stephen Schueller, Ph.D. Now, Dr. Schueller is passionate about using technology to create effective and scalable mental health treatments and making sure they're accessible to mental health services. And this work lies at the intersection of clinical science, implementation science, and human-computer interaction. And in his research, Dr. Schueller develops, evaluates, and implements digital mental health assessments and interventions, including internet websites, mobile apps, and wearable devices.

So let's begin the conversation, gentlemen, by exploring how apps may support mental health treatment and what sets digital therapeutics apart from all the many general wellness apps. Because I've been doing a bit of research myself, and I can see that the standard app store, well, it's a bit like the Wild West when it comes to health and wellness apps. Over 350,000 of them available for download in 2021, and goodness knows that figure must have increased enormously. So, guys, what advice would you give to patients or clinicians who are trying to evaluate these options in an app store and determine what they should use to address mental health issues? Can we start with you, Stephen?

Dr. Schueller: Sure. Well, I think it's really important to note that when an app makes its way into the app store, it hasn't necessarily gone through any clinical vetting, that these app store markets are evaluating them based on some— some basic principles: does it meet their terms of service; does it meet basic, sort of, technical checks? But they're not making sure that that app actually can do what it says it would do clinically. That's very different from digital therapeutics, which are products that have demonstrated a clinical benefit, as a treatment, to be able to impact the clinical health condition that it's meant to impact, so in the case of mental health, it can actually have a demonstrated impact on depression, anxiety, bipolar disorder, sleep. And so when you go to the app store, I would just sort of note that those products have not been vetted. Instead, I think really trying to consult different trusted sources, either, you know, a regulator that's actually looking into evaluating these things, an insurance company or a payor that's actually done the diligence to determine that this is actually a product that they want to pay for and make available to the patients that they cover. So, I think, you know, really going to those trusted sources is important because apps on the app store, you know, could have a benefit but a lot of them, we just don't know, they haven't been vetted in any sort of rigorous, clinical way.

Jilly Carter: So there's more of an element of trust here because they are evidence based?

Dr. Schueller: When we talk about digital therapeutics, and again, these are products that have demonstrated benefits in terms of their clinical efficacy, then I think that that does have that higher level of trust than something that we would just find on the app store from searching in depression or anxiety. I think the challenge is being able to sort of suss out and understand which one are these digital therapeutics and which ones are these just wellness-focused products? I think that's really why we have to kind of turn to trusted sources, and I think that regulation and those trusted sources is still really evolving. This is a new and emerging space, and so I think that's one reason why it's really important to stay current with what the developments in this field are right now.

Jilly Carter: And, David, presumably you would agree with all of that?

Dr. Mohr: Yeah. No, I, I agree 100%. And maybe I can add a little bit kind of on what the, you know, what the risks are. Now, you know, there certainly are a lot of apps out there and digital mental health treatments that are effective and good, but there are also a lot of potential risks. So, you know, one is that the app is not constructed well, that the content isn't good. So a lot of the apps out there are just developers who are creating apps, and they're doing what they think is good, but they're not using evidence-based principles or psychological strategies. So they may be nice to use, but they're unlikely to be beneficial to the person.

And then there's the, you know, the slightly more— the kind of higher-level risk, where there are actually some apps out there that are dangerous. So, you know, one of my, one of my colleagues, Jennifer Nichols, who used to be here as a postdoc and is now at the University of Melbourne, she did a meta-analysis a few years ago looking at apps for bipolar disorder. And there was one app in particular that recommended when a person is going into a manic episode that they self-treat with alcohol, which is definitely not what you want to see for, you know, somebody starting to have— go into a manic episode.

So some of them actually could be potentially dangerous. The other danger or risk with just pulling down apps on the app stores is that you don't know where the data are going. And so, a colleague of ours, John Torous at Harvard University, does a lot of work in this area in privacy and security, and a lot of the apps out there, you know, don't have adequate privacy policies. And even, you know, those that do, you know, often what they're doing with their data doesn't match what is in the privacy policy, that— that data are going to third-party companies, other, you know, other organizations without actually informing the person. And so there are a lot of risks, and I think that underscores, the, you know, the importance of patients and clinicians to use guidance where it's available from healthcare systems that have, you know, put in the effort to evaluate these applications or, increasingly, the FDA.

Jilly Carter: It doesn't seem very clear to me, who's responsible for what— whether it's the doctor, the clinician, or the patient? There seem to be an awful lot of questions to ask and to call this the Wild West is really not far off the mark, is it?

Dr. Mohr: Oh, no, it isn't. I do think that that is going to change. And I think it is— it is beginning to change in many countries where they are developing regulatory systems. They're developing payment models. It's beginning to be rolled out into healthcare systems. And I think we are on the verge of that, you know, in the United States. But this is going to be a long, long process. So, you know, it took a long time to tame the Wild, Wild West, and it's going to take a bit of time to tame digital mental health.

Jilly Carter: So do you see any other potential risks that patients might need to protect themselves from before using a general app for monitoring or treating their mental health condition?

Dr. Mohr: I mean, I think it largely falls into those categories of what's the content and is the content you know, truly, you know, based in evidence and, you know, the risks of privacy and security. Can you think of anything else, Stephen?

Dr. Schueller: I might add one more, and I think this is one that actually does worry me a little bit in this space. And that's the risk of delayed effective treatment. I do worry that some people might use a digital mental health treatment, download an app from the app store, and not get better, and then think to themselves, you know, I tried that, I tried that mental health treatment stuff and it didn't work. And either, you know, those treatments don't work or I'm someone who's not going to benefit. And so I think that is a really important reason.

You kind of mentioned, you know, what's the role and responsibility of providers, that the provider can play an important role by, if a patient is using a digital mental health tool, that they can check in on them, see how it went, and I think when a provider is providing a digital mental health tool, setting the expectations of what the patient might expect to see, how often they should use it. And again, following up on that, because I do worry that some people might start to use these tools, like I said, not get better, and then not make their way into— to formal treatment.

And so I think that even, you know, digital therapeutics, which have clinical evidence, need to fit into sort of a clinical care delivery pathway. There might be some times that a patient is using it on their own a little bit more and getting some significant benefit from it. But then there's other times where it has to come back to the provider, and the provider has to do that, check in on their progress. So, I think just, you know, that is something that does worry me, is that some individuals might be delaying effective treatment because, as noted, there's a lot of these tools out there that at best are ineffective but, as David noted, might actually be harmful in some ways.

Jilly Carter: Yeah. I mean, we need to focus on the fact that these need to be legitimate medical treatments and not the ones that are not. And, I suppose, if a patient tries one of these apps and thinks, oh, I can't, I can't be doing with this, it's not working. And goes and reports that back to the doctor. I mean, the doctor doesn't have all the time in the world to check out all of these apps, and the doctor will be influenced by that, and maybe it was just because the patient was using it in the wrong way or didn't understand it, or, you know. A valuable treatment could be dismissed unnecessarily.

Dr. Schueller: I think that's right. But I think the same thing is true in other treatments. And I think doctors can kind of ask some similar questions that they're used to in other models. So, for example, if you prescribe a patient a medication and they say it's not working, you might ask them some questions about like, you know, okay, well, when are you taking it? And they might say, “I'm not,” and then it's not going to work. So I think similarly with these digital therapeutics, people do have to use them to get the benefit from it, just like a medication. They have to stick with them. And some of these tools might be tools that might be a little bit more cognitively challenging. Not all of them are, you know, it's not the Angry Birds of mental health treatment. So not all of them are fun and gamified. It could be something that's more like, you know, a cognitive training test or a crossword puzzle, you know. They can be engaging, but they're not always easy, and I think that that's something that, again, doctors can check in on and make sure that people are using it— using it as intended.

So I think understanding the proposed, sort of, use case and use parameters around digital therapeutics is an important piece that a doctor can check in on, just like they would be checking in on a patient's use of a medication or if they're attending psychotherapy or were referred to psychotherapy, making sure they're actually attending those sessions.

Jilly Carter: Yeah. I mean, this— this really does come down to the fact that digital therapeutics are technologies that aim to prevent, manage, or treat aspects of a disease and illness, and that's what separates them from general health and wellness apps. So, basically, they're more trustworthy. We can trust them because they've got the regulatory development behind them, and also sometimes—correct me if I'm wrong, Stephen—it can take 2 or 3 years or more to develop an app like this.

Dr. Schueller: You're right. Developing digital therapeutics is not a simple process. It takes years of development to be able to make sure that one does the right work in terms of working with patient and provider populations to make sure that the app makes sense to them, it's easy to use, it's understandable. It takes time to develop that clinical evidence that we've been talking about. So to go through the stages of research, feasibility trials, clinical trials, to be able to demonstrate that this tool actually leads to the benefit that it's supposed to benefit. And also, you know, it takes a lot of interdisciplinary collaboration between individuals from different fields for making sure that the designers who can really create engaging interventions and the clinical experts who really have the expertise in those clinical treatments have weighed in and that different patient and provider groups have provided feedback from their perspective.

So it takes a lot of coordination from large teams and interdisciplinary teams to develop these works. So this is not something that is easy, to create a digital therapeutic. And I think that, again, this is something that differentiates them from wellness apps. Anyone can develop an app and put it up on the app store and can actually do that very quickly.

And I've looked at thousands of these different digital mental health apps. I can tell you some of them that show up on the app store are quite lean and don't really do much. That they're very sort of simple interactions that, you know, would not be expected to have any sort of clinical benefit. So, I think, again, if you're going the direction of digital therapeutics, you're looking for a treatment that is more robust, more reliable, and again, has that clinical evidence supporting it.

Jilly Carter: Now many patients with mental health issues have a good relationship with their psychiatrist. It's a one-to-one, intimate kind of relationship, really, where the clinician really knows and understands the patient in front of them. Can you describe for us, both of you, how digital therapeutics could be and can be personalized to the patient? And what is the clinician or clinicians’ involvement in all of this? David?

Dr. Mohr: Yeah, I think, so digital therapeutics, you know, people will need different things from digital therapeutics. And so I think one place to start is to ask, kind of, what is the digital— what can the digital therapeutic do for the patient, and what can the digital therapeutic do to help the clinician treat the patient? So, I think there's a couple of different— a couple of different areas where, you know, we might talk about that.

So one is in evaluation. So, you know, when a patient is being treated by a psychiatrist, the patient comes in once every few weeks, usually the appointments are relatively brief, and the patient then reports about how they've been doing over the past week. And, of course, we know that with mental health problems–—problems, symptoms, they can vary quite a bit. And so digital therapeutics can evaluate people and provide a picture of how people do— are doing in the real world. And that can be both symptoms, it can be their, you know, aspects of their lives that are related to treatment, like how much they're going out or, you know, getting out of the house or doing things that they should be doing or adhering to their medication. So that kind of about— it provides— it can provide, you know, evaluation that's really embedded in the person's life and bring that into the room when they're meeting with the psychiatrist.

And the other aspect is treatment, so, you know, psychiatrists generally prescribe medications, and psychiatrists are more expensive. So many psychiatrists don't provide very much in the way of psychotherapy, and when they do, there may also be sort of behavioral interventions that are useful for the patient that they don't necessarily have expertise in. And so digital therapeutics can provide that— so they’re, you know, if a patient needs, you know, might benefit from mindfulness, you know, having an application that assists the patient in practicing that mindfulness. If there are, you know, applications that assist people in aspects of cognitive behavioral therapy, like behavioral activation, getting out and doing more things that are positive and getting more engaged with life or cognitive restructuring, sort of identifying, you know, ways in which the person's thinking is kind of helping them, you know, or essentially leading them to be more depressed or anxious. So all of those kinds of things there are, you know, apps, you know, apps and digital therapeutics that can help with that. So they can be extenders, essentially, of the treatment. Extending the treatment into the fabric of people's lives and extending also the capacities of clinicians both in terms of the time limitations that they might have as well as the expertise that they might have.

Jilly Carter: Yes, and I suppose if a patient was on the fence a bit, unsure about whether to use these digital therapeutics, if there was a confident clinician who was encouraging them, actively, to seek them out, then that would again engender trust and reliability and a good relationship as part of the whole treatment process.

Dr. Mohr: Absolutely. The way in which digital therapeutic is introduced by a clinician, and they're introduced, they can be introduced by psychiatrists, we’re also are seeing implementations where they're introduced by general internal physicians or primary care physicians, so they— social workers. So, and the way that that's introduced is really critical to the— to the uptake. So, you know, the clinician has to be both, you know, reassuring that it's— that it's effective, as well as enthusiastic. So, you know, letting the patient know that there's a lot of evidence that these have been, you know, used by countless numbers of patients and they've benefited from it. You know, emphasizing that research is important, but it's not sufficient because most— many patients, you know, what they want to hear is a personal story. So it's very helpful if clinicians can say something like, you know, “And I've had a number of patients that have used it, they've liked it, and I've seen them get better.” So that kind of— that kind of personal story is important.

And then describing what the digital therapeutic is to the patient, letting them know what they’re— what they’re— what they're getting into. So this is, you know, this is an app that, you know, you'll download it and, you know, it will do this and this and this for you. And, you know, it's most helpful if you use it every day or whatever the expectation is. So let the— let the patient know what's in the therapeutic, what their experience is going to be and what the expected— what the expected usage is going to be.

And then the third thing is not necessarily, not exactly, introduction, but following up with the patient afterwards. So on the next visit to ask, you know, did you use it, did you have any problems, did you like it? To integrate that digital therapeutic into the process of care just as a— just as a clinician would do with anything else that they— that they prescribe or recommend. You know, a psychiatrist will always follow up on the medications that they're using, so integrating it— integrating it into the— into the processes of care. So those I think are really, you know, essential, and it is, you know, it sounds like a lot as I'm speaking, and clinicians often don't have a lot of time with their patients. They have a lot to cover, but those messages can be boiled down and be delivered pretty quickly and pretty effectively.

Jilly Carter: Stephen, I mean, every patient is different, every patient is an individual and is going to respond in a different way. But have we any idea about how often and how long patients need to use these apps to see results?

Dr. Schueller: I think that's an emerging question that the field is trying to grapple with is, you know, how long do we need to use these things to be able to get a benefit from them? I think that the majority of trials of digital therapeutics that I see typically are in like the 6- to 8-week range. So we see, you know, pretty good benefits in those first 2 months of treatment. And, you know, that's about half of the time it takes for a sort of regular dose of psychotherapy. So typically, you know, we think about sort of a dose of psychotherapy as sort of 16 sessions over 16 weeks. I think that we have some real questions about the durability of these, the impact of these technologies, and are these things that people are going to have to go back to. And I think that that doesn't mean that these treatments are ineffective. I think that we see lots of places where there are treatments or things that people would stay on for long periods of time—antidepressant medication. If someone took my glasses away from me, I'd be very disappointed, and that doesn't mean that glasses are an ineffective treatment for the problem that I'm faced with. So I think it's an emerging question in terms of booster sessions or repeated use of different digital therapeutics, but, as I said, I think a lot of the trials of these things usually are looking at them in terms of the 6- to 8-week sort of mark, and people really get some benefits in those initial sessions.

Now, I'll also say about a challenge that we see in the real world, and especially apps that are available on the app store, as we've talked about earlier, is many people, if they download it, don't go back to it at all and that most people stop using it within the first 2 weeks. So I do think that, you know, getting people past that 2-week mark, getting people to persist after those first couple of weeks is really important. And as David noted, that can be a really important role of the provider, to check in, especially in that first session, after you recommend or refer to a specific digital therapeutic, make sure that the patient was able to download it, that they didn't have any problems in doing so, that they're able to get onto the product, and that they were able to start using it, that they don't have any questions or challenges. If you can get them through those first weeks, I think that's actually really important and getting to that point where we typically start to see sort of therapeutic doses of these types of treatments.

Dr. Mohr: I agree with everything that Steven has said. I just would like to add that, you know, I think the question of how long is also just a question of what good care for mental health is. So there's a, you know— measurement-based care is a— is a concept that has been around for a long time or a method of practice. And all it really means is that we measure the patient's symptoms on a regular basis. And on a regular basis, every 6 to 8 weeks, those— you know, how the patient is doing or responding to the treatment. There's a discussion between the clinician and the patient about how that's going, and if they aren't improving adequately, that there's a change, that there's a discussion about how to change the treatment. This unfortunately does not occur nearly enough in the— in the— in the treatment of patients with mental health, especially when it's outside of— outside of mental health providers where most of mental healthcare occurs, and digital therapeutics shouldn't be treated any differently. That when a patient is prescribed that, they— there should be a follow-up. Are they using it, is it effective? And if it's— if it's not sufficiently effective—and I'm a huge proponent of digital therapeutics, but it's not going to be effective for everybody because nothing is—that then there's a discussion about, you know, do we continue the digital therapeutic? Do we add a medication, do we add, you know, add psychotherapy? So I think that that consistent follow-up that should be occurring with all, you know, in all mental health care that is— that's part of the decision about, you know, how long to— how long to use a digital therapeutic.

The other thing that I would add is that, you know, we've seen with patients, you know, once they're effectively treated, a lot of variability in terms of how people want to use it afterwards. So some people, once they're— once they're done, once their symptoms are done, they're done with the digital therapeutic, you know. Their problem is solved, and they're moving on with their life. And there are other people that come to value the kinds of support and interactions that they have with the device, and they find that it's useful just to keep using it. And so, in that case, it's, you know, it becomes like Stephen's glasses, right? They're a useful support for the person, you know, in the course— in the course of their life.

So there's a lot of variability across patients. And I think we need to listen to them in terms of how long, you know, how long people should persist after the symptoms have resolved.

Jilly Carter: And as you both have said, this is all a question of joined-up thinking and best practice in caring for patients. I've heard the phrase “clinical champions” bandied about quite a lot. I guess we need these clinical champions if these apps are going to really take off and be truly beneficial to patients.

Dr. Mohr: Yeah, I think— I think you're getting into the question of how to implement them into care systems, and that I think is today one of the— one of the big challenges, you know. It's— there are a few cases where we've, you know, I've seen, you know, successful implementations, but there's a lot, you know, a lot that have not gone as well, and, you know, there are a, I think, a number of different factors that— that need to be in place to have a successful implementation in any kind of— any kind of organization that's delivering mental health care.

So first of all, you have to have buy-in from all of the stakeholders. So leadership in the organization is critical. The business and finance people, the clinicians, often IT, the patients themselves. Often there are sort of member or patient advisory groups within the organization. They need to be included. And staff, frontline staff, people who are talking to the patients. They talk to patients, and so if you're delivering a new treatment, they may end up talking to them. So they need to be trained. Everybody needs to be on board and then— and then you, you know, as a group, as stakeholders, the objectives need to be clarified and measured throughout. And then the implementation begins.

There's an implementation plan, and often when that's implemented— when it's implemented in the clinical services, there is this person that we often refer to as a champion. So that's often a clinician within that clinic who's particularly enthusiastic about it and who can help deliver the message to other clinicians and also is a conduit of information back to the implementation team. And so when they see problems emerging, they're the ones that come back and talk to the implementation team. This isn't working, that isn't working, and there's discussion. They, you know, then go back because nothing— you have an implementation plan, and I can virtually guarantee that it will not work, out of the box. You know, this constant iteration that needs to occur, adjusting it, fixing problems that come up, but the clinical champion in— in that implementation is really— is really critical because they're the ones that— that— that understand the clinic, that have enthusiasm about it, they have some drive to make this work. And they are a conduit of information. So they're communicating with the broader implementation team.

Jilly Carter: You were mentioning earlier, David, that patients like to hear from their doctors words of encouragement, et cetera. Have both of you, either of you, got any inspiring stories that you'd like to share of these apps really working in the community health environment?

Dr. Schueller: I think one story, I've heard versions of this a couple times, and this is really sort of framed towards the providers and the practitioners, is I've heard from lots of clinicians that they've had a patient that they've been trying to introduce a new treatment to. Perhaps, you know, cognitive behavioral therapy for insomnia, which is an evidence-based treatment, to help people with their sleep problems, and they’re framing the rationale for the treatment and trying to get the patient on board and describe what's going to happen. And then they mention, like, okay, and we're going to use this app to help support you do it, here's this cognitive behavioral therapy for insomnia app. And the patient says, “Whoa, there's an app for that? So it's a real treatment? You're not just making this up?” And, you know, I, as a provider— I've got letters after my name— it's kind of interesting to me that the patient, you know, is— if we're talking about it, they think it's made up, but if there's an app, if there's a thing, if there's this digital therapeutic that exists, they believe this is a real, codified, bona fide treatment. There's an app that supports this thing. And so there's been a lot more level of buy-in early on from some patients. Once they've sort of introduced that digital therapeutic, it really sort of helps support the treatment rationale. And the clinicians who I've talked to, who've told me some version of this story, have been really then inspired and also enthusiastic about using that treatment because they create such, you know, a quick bond and— you know, bond around— with the patient, around this app that's going to help them get that evidence-based treatment. So I've heard that a couple times, and it's been really interesting to hear that from clinicians who are on the frontline, really kind of trying to use some of these tools in their practice.

Dr. Mohr: So I have lots of, you know, lots of stories because, you know, we— when we design these tools, we do get a lot of feedback from people. So we, you know, we try to understand their experience, in part to try to improve it. And so we get a lot of stories back. And, you know, this is some of the projects that I've worked on with Stephen, you know, the— you know, we hear back stories from patients, and two that I— two that I, you know, come to top of mind.

One was, you know, a young— a young person who, you know, was very, very, very depressed and— and was, you know, having a lot of difficulty. Not sure where he was going in life or what he wanted to do and sort of— and, you know, he talked about how this application that we were working on really helped him. And it was a very simple tool that just had him checking, you know, a checklist. And so it has him checking off four things a day. And it starts off with get out of bed, eat something, you know, go out of the house, et cetera. And that, just knowing that he had to check those off at the end of the day helped him begin to get himself motivated, get himself out of the house, and get himself started again. And he, you know, he talked about how helpful that was.

Another story that I remember that, you know, just stuck with me was a nurse who, you know, working on a floor of a hospital, which is incredibly stressful work, and she was just completely overwhelmed. And she talked about taking an app that had a whole kind of— some different relaxation, mindfulness tools in it, and she would just go into a closet on the floor and listen to it for 5 minutes, 2 minutes, 1 minute. Not the way that it was designed to be used, but just that way, in order to kind of bring herself down so that she could get back out on the floor. And so, you know, what impressed me is that— how much people will find something in these— in these tools that really helps— helps them and then be able to use it in a way that benefits them.

The other— the other kind of story that, you know, it was impressive to me was with the healthcare system. So we deployed it, a digital mental health intervention, in the University of Arkansas Primary Care Clinic. And it was a pilot, and so it was a fixed period of time. It was, you know, I think for 4 or 5 months that we were in there, and when we were— when we wrapped it up, there were several administrators and several clinicians who turned to us and turned back to us and said, you know, can we keep using this? Is there some way that we can keep— that we can keep— that we can— that we can keep this in our practice? Because the clinicians had seen, you know, that patients had come back to them and said, you know, I like using this, this is really helpful.

And that then motivates, you know, that positive feedback from the patients to the clinicians motivates them because clinicians, number one, they do want to help their patients, and they do— they do want to see them get better. And then the other thing is that for a lot of clinicians, when— especially in primary care, when they come in and they're dealing with patients that are depressed, they don't always know what to do. So having something that they can give them, you know, give them that's relatively easy access, that's effective, is helpful to them in their practice.

Jilly Carter: The word that you mentioned there, access, I know that both of you feel passionately about this. The fact that this could be another tool to help patients gain access to good mental health care, because there aren't enough clinicians around, there aren't enough psychiatrists, they're stretched as they are. So this could be enormously valuable for patients to get access to these apps.

Dr. Schueller: I think that's really true. And I think that just to expand on some of the challenges and then also the potential solution here, we're never going to have enough providers in the right places. Providers are not sort of geographically distributed equivalently. Provider populations often don't match the patient populations in terms of cultural background or linguistic matching. So I think that it's not just about not having enough providers, but it's having providers in the right places and providers that match the demographics and the backgrounds of the patients that they're trying to help.

I think another thing we've seen in terms of the data from some of these digital therapeutics is, often when people use them most, are outside of business hours. They're using them, you know, late at night when they're actually struggling with problems. And so it also provides patients an opportunity to get effective treatments at the times and places that they need them the most. And usually that's not, you know, 9 to 5 when their therapist’s or their psychiatrist’s offices are open and they're available for appointments. And so I think it also helps create a little bit more, sort of, support at times where patients might really need that extra support and when providers are not necessarily available. So even if we had enough providers, these tools allow people to really get support, you know, as you noted in the introduction to David, in the fabric of their own lives. In the times and places that they need them the most.

Dr. Mohr: And, yes— and, you know— and we will never have enough mental health providers. It's just— that's, you know— it's just not feasible. But I think that we— I think that digital mental health really is a revolution in mental health. And I think that, you know, I think in mental health treatment, there have been two revolutions up until now, the first being psychotherapy. So, you know, with Freud et cetera, the idea that talking can be a cure. I mean, that was a revolution. Prior to that, people were thrown into asylums. There was— there was really— there was— there was really no effective treatment. And that idea that we, you know, through talking and through learning, people can— people can— you know, that can treat mental health. Huge change.

And then the second, in the 1950s, with pharmacotherapy. Beginning to understand that there's a— there's a biologic— the biological bases of mental health problems. The development of medications. This I think is— I think digital mental health is a revolution on that order. It's a completely new, different kind of treatment that can, you know, open up access to millions of people that have, you know, heretofore not had— not been able to get mental health treatment.

Jilly Carter: And I imagine that you would concur with everything that David has said, Stephen. Excitement about the future.

Dr. Schueller: Yeah, I have a lot of enthusiasm for the opportunities that digital mental health treatments bring and that prescription digital therapeutics can really usher in. Especially as they can help create awareness and also support better trust in effective treatments. So I think that we've entered a first stage, and, you know, that first stage, as you noted, is somewhat of a Wild West. But I really think with increased regulation and awareness and trust in these treatments, there's a huge opportunity to bring care to people who would not get it otherwise.

Dr. Mohr: And I think we're starting to enter the second phase. And that is, that, you know, that regulation is emerging. So around the world, you know, we're seeing, especially in developed countries, we're seeing the emergence of regulatory systems. We're seeing the emergence of payment systems and reimbursement systems so that they can be integrated into health care. And I think, in the United States, you know, a month ago or so with the Centers for Medicaid and Medicare Services—CMS—you know, they have a proposed rule for billing codes that will start in 2025.

That is beginning, I think, this next phase of being able to really— having, kind of, the regulatory and the economic mechanisms in place to be able to truly integrate these into the American healthcare system. And it's not going to change overnight. This is going to be— it's going to continue to be, you know, a slog, to get these effectively integrated. But we are making— we are making progress, and the progress actually is moving, you know, from policy perspectives, relatively quickly. There is a lot of, I think, energy in the United States, a lot of energy around the world, because, I think, you know, governments, companies, healthcare systems recognize that we're in the midst of a mental health crisis. Covid was a huge accelerator, so there is a lot of momentum behind this at this point. So it's a— it's a very, very exciting time for digital mental health.

Jilly Carter: It certainly is. And I think we should end on that really upbeat and positive note. Gentlemen, thank you so much for sharing your views and explaining very clearly the potential for digital therapeutics in mental health care and how they are very distinct from wellness apps, and what they offer both to patients and clinicians. Gentlemen, thank you very much for your time. Onwards and upwards. Thank you.