How digital therapeutics can improve behavioral health [PODCAST]

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“To better meet the needs of patients, providers can improve access to treatment and offer more immediate solutions through the use of prescription digital therapeutics (PDTs). With technology, providers can now deliver programming aligned with proven mental health treatment methods, such as cognitive-behavioral therapy, and connect teens and young adults to an immediate, safe, and effective treatment option.

Technology cannot replace good patient relationships, but the future of mental health care rests in leveraging technology that complements a clinician’s hands-on care. The last year and a half has underscored the need to shift rapidly and use new solutions in a meaningful way. People are becoming increasingly more receptive to telehealth and virtual treatment – especially teenagers and young adults. Now is the time for physicians to consider digital therapeutics to quickly and safely support their patients who need mental health treatment, intervening early to achieve better outcomes.”

Benjamin Alouf is a pediatrician.

He shares his story and discusses the KevinMD article, “How digital therapeutics can strengthen the provider-patient relationship and improve behavioral health outcomes.”

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Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.

Transcript

Kevin Pho: Hi, welcome to the show where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show we have Benjamin Alouf. He is a pediatrician, and he co-wrote the KevinMD article “How digital therapeutics can strengthen the provider-patient relationship and improve behavioral health outcomes.” Benjamin, welcome to the show.

Benjamin Alouf: Thank you very much. I’m glad to be here.

Kevin Pho: Can you share your story and journey to where you are today?

Benjamin Alouf: Sure. I’m a board-certified pediatrician. I worked clinically for approximately 15 years in large hospital systems and academic medical centers, and after 15 years of clinical practice, I jumped over and worked on the health side, sort of the other side of health care, the payer side. I spent about 10 years there, nine years there.

And then over the last year or so, I couldn’t help but open up a pediatric journal talking about the mental health crisis in adolescents and children: increasing anxiety, increasing depression, increasing eating disorders, with even more limited and difficult access to care. And I found Limbix Health, a company that was working on prescription digital therapeutics for mental health in adolescents. I thought this would be a great opportunity for me to get in on the ground floor of something truly innovative and something truly creative, and a company that’s really trying to solve a problem. And so from these big hospitals and big health plans, I joined a little startup, and it’s been wonderful ever since.

Kevin Pho: So you moved from 15 years of clinical pediatrics onto the payer side and now joining a health startup. Tell me about some of the challenges along the way in making those.

Benjamin Alouf: You know, it’s a steep learning curve. It’s a different mindset. Clearly, being on the clinical side and working with patients, working in a hospital organization, and then going over to the payer side, where you’re doing a lot of medical necessity reviews, is a very different atmosphere. There were a lot of the regulatory requirements, having to learn about different models of care and models of payment and how they apply to prior authorization and so forth.

And then moving to a very small company was challenging as well, because it’s a little bit more technology-focused, adapting to different platforms. But the nice thing about it was that you really started to recognize how, when you’re in the clinical space, we hear, for instance, about social media and how technology is actually exacerbating some of the mental health conditions. And what was truly nice is seeing how digital therapeutics and the technology can actually help children, and help battle.

And so some of the challenges are educating providers about that, as well as bringing these products to market, both from a commercialization standpoint and from an FDA regulatory standpoint, learning all the regulatory requirements to achieve that.

Kevin Pho: So we’re going to talk about your article shortly, but before we do, we mentioned the term prescription digital therapeutics. So for some background, what exactly is that?

Benjamin Alouf: So prescription digital therapeutics are therapies that are cleared by the FDA as being safe and effective to either prevent or treat a very specific disease. So unlike some of the other wellness apps or AI apps or products that are out there that are digital therapeutics, prescription digital therapeutics have to pass very strict regulatory controls. They have to have very specific indications for use. There’s a lot of regulatory scrutiny, so you can’t just put something out there and offer it. In order for you to declare that this is what you’re treating and this is what it’s effective for, you really have to present that with substantial data. And it sets apart those particular therapies, because they are FDA-reviewed, and they are shown to be safe and effective for what they are stating they are going to be treating.

Kevin Pho: So can you mention some popular examples of prescription digital therapeutics that my audience may have heard of?

Benjamin Alouf: So there is Akili, which has Endeavor for ADHD. The first one was Pear’s reSET for substance use disorder, and those were some of the first ones to be reviewed by the FDA to treat specifically substance use disorder and opioid use disorder, in on it from Pear. They now also have one for alcohol, and also Akili’s Endeavor for ADHD.

Kevin Pho: Let’s talk about the KevinMD article that you co-wrote. It’s titled “How digital therapeutics can strengthen the provider-patient relationship and improve behavioral health outcomes.” Now, for those who didn’t get a chance to read your article, can you just walk my audience through it and share the story of why you decided to write it?

Benjamin Alouf: Sure. So one of the things, again, you talk about challenges in terms of commercialization and educating providers about digital therapeutics, and prescription digital therapeutics specifically: It’s very novel, it’s very new, and again, there’s such a broad scope of what’s already out there in terms of telehealth and coaching apps. And I met with Dr. Jaradat; we worked together at a hospital. She’s a child psychiatrist, and I wanted to show her SparkRx. I wanted to demonstrate to her and just get her thoughts on how we get providers to accept it and to learn about it.

And there were several common topics that came up. Number one is, what is a prescription digital therapeutic, as we’ve discussed. But number two is, how do we integrate this into our care? Historically, technology and digital interfaces in the workspace for providers have been somewhat of a hindrance. They were somewhat of a disruption to the flow of patient care. So how do you show that these are actually there to support you? It’s a lever to pull. It’s something you can provide. It’s not meant to replace you. It’s not meant to replace what you’re already doing, but it’s meant to complement it. It’s another object for you, another app for you to send the patient home with to continue along with the therapy journey.

And so as we talked about it, number one, you need to educate on what a prescription digital therapeutic is and how prescription digital therapeutics stand apart. And then number two, how this is meant to help you and how you can integrate it into your clinical care. And one of the things she was also mentioning is that as a pediatric psychiatrist, she has long waiting lists, right? We were also discussing how this is a great opportunity for primary care providers to use while they’re waiting to get seen by a licensed behavioral health therapist.

Kevin Pho: Now, can you paint a picture and share a case study of how a prescription digital therapeutic can help in the field of adolescent mental health?

Benjamin Alouf: Sure. So right now we know that we’re in a crisis, right? The surgeon general has come out with a statement. The American Academy of Pediatrics, the American Academy of Child Adolescent Psychiatry, and the Children’s Hospital Association came out with a statement that we’re in a crisis. Primary care providers are being called upon more and more to be the ones who provide behavioral health services to children, simply because there isn’t access. There isn’t enough supply of behavioral health therapists.

So if a pediatrician sees a child in their office, they do a PHQ, which is a questionnaire to screen for depressive symptoms, which is part of the annual adolescent visit. And they find that the child tests positive in the range of scoring for depression. Currently, waiting times are 3 to 6 months. We hear in some remote areas they’re 9 to 12 months. It’s just untenable.

So they can provide the adolescent with a download through a QR code. They can download it from the App Store. They put in an access code that is unique to the provider, and the child can start using it as a therapy, either to continue some therapy with a primary care provider (as I stated, some primary care providers are starting to give some behavioral health therapy) or as they’re waiting to be seen by psychiatrists or psychologists or other behavioral health therapists.

And it’s based on cognitive behavioral therapy, and specifically behavioral activation, which has been shown to be effective in adolescents, and it walks them through different levels of engagement. The active ingredient, so to speak, is that behavioral activation of cognitive behavioral therapy.

Kevin Pho: So walk us through a little bit more about what the app does. If I’m an adolescent patient who was prescribed this digital therapeutic app, walk us through exactly what that app does. How often does this patient need to engage with it? What kind of follow-up does this patient need?

Benjamin Alouf: Sure. So number one, there’s a psychoeducational component, teaching about depression, teaching about how there are triggers which lead to certain behaviors, which can then aggravate or exacerbate states of depression. And then it moves along the continuum to identify certain activities that are up activities versus down activities. It also identifies favorite activities, and also identifies activities that are based on what values and what value systems the teen might have.

And then it works with the teen to schedule activities that are either favored activities or activities seen as adding value for the teen, like spending time with family or spending time with friends. And then it has them track their mood before and after doing the activity. And it walks them through it, so it’s not just, “You like spending time with your family. Go spend time with your family.” It really walks you through: When are you going to do this? Who are you going to do it with? Who are you going to tell about it? What could possibly go wrong? And then there are strategies around alternatives should the event, you know, you want to go outside for a walk, but it’s going to rain. What are some alternatives?

And then it checks back with you to see: How did it go? Did it turn out the way you expected it? If not, what were some of the coping mechanisms you used to accommodate those changes? And then it tracks you along, and you get little rewards. There’s a bit of gamification where there’s a little campground, and you can add things to your campground on one of the screens. We have a teen advisory council, and they think it’s very engaging. The adherence has been very strong from the study that we did. It really walks them through the important stages of setting up activities that result in positive mood through certain behaviors.

Kevin Pho: Can you talk about some of the data and studies articulating the efficacy of the app?

Benjamin Alouf: Yeah. So when we did it initially, our study showed that there was a greater than five-point reduction in PHQ scores, which is a clinically meaningful reduction. And then we actually presented our poster at the American Academy of Pediatrics, and we won one of the top three posters in our group, which was very, very rewarding. It was wonderful to see that people are interested in this and see this as valuable and appreciate the data.

And what we found is in the teenagers that followed through the path, and it’s five different levels, each level has several modules in it, the ones who completed it per protocol had a 21 percent remission, meaning their PHQ score dropped to less than five, versus four percent in the control app. For us, the control was a sham app. It was an app that just provided some resources, some psychoeducational information, but didn’t have the active ingredient of behavioral activation. Twenty-one versus four percent in the per-protocol population for remission.

Kevin Pho: We’re talking to Benjamin Alouf. He is a pediatrician, and he co-wrote the KevinMD article “How digital therapeutics can strengthen the provider-patient relationship and improve behavioral health outcomes.” Benjamin, what do you see on the horizon when it comes to prescription digital apps in the adolescent mental health space?

Benjamin Alouf: What I see is providers truly embracing this. In talking to colleagues and reading about what’s happening in primary care, especially with telehealth services, urgent care services, with virtual-first services, I get a feeling, and some have expressed this to me directly in person, that the primary care provider is being replaced by alternative therapies that, either real or not, are seen as more convenient than seeing the primary care provider, or more accessible.

And what I would like to do is let providers know that it’s not all true. A lot of the technology is there to help you. It’s there to facilitate, to help you take care of your patient. Make it part of your workflow. But it’s also very important for providers to be part of that conversation, to get involved. As I mentioned earlier, in the beginning, technology and the introduction of electronic health records were somewhat disruptive. Providers pushed back a little bit. And we do have the ability now to make this seamless in your care. It’s certainly never the intention to replace the wonderful care you’re already providing, but to help you, to have something that the patient can go home with, something that you actually can get feedback from.

One of the things we’re doing is we have a provider portal that actually tells you how the patient is responding to the therapy and how much the patient is engaging with the therapy. And I think of it, you know, when I was practicing, when I wrote a prescription for a patient, I didn’t know if they were taking the medication. I didn’t know if they were compliant with it. I didn’t know if they were improving or not improving unless I called them or brought them back in for a follow-up. Here you’re actually getting data. You actually are seeing the results right in front of you. You’re getting back how much time was spent on the app, how many levels, how many modules are completed, what the subsequent PHQ scores are, and what those results are, which I think is wonderful.

And the other thing is you can actually download these apps for yourself and use them and demo them and see what they do. How often do we prescribe medications to patients and say, “Oh yeah, this thing is exactly how I was feeling”? We don’t take most of the medications we prescribe. Yet with these digital therapeutics, you can actually demo them and see what they do and actually have some understanding of what your patient is experiencing. And that’s just, I mean, that’s mind-blowing. It’s truly disruptive, in terms of thinking of digital therapeutics as having active ingredients that you can monitor the success of, and the therapeutic response to, and the compliance with, and also see how it works because you’re using it yourself.

Kevin Pho: And my final question: What are some of your take-home messages that you want to leave with the KevinMD audience?

Benjamin Alouf: I would like to see them trust the technology and also get involved. They’re starting to include more and more digital therapeutic and digital health breakouts in conferences. Go listen to them and provide input. We go to these conferences, and we love talking to providers and hearing what they have to say and getting their feedback, because that’s what we’re doing it for, right? I mean, the end user is the patient, and obviously we’re treating the patient, but we also want the providers to want to prescribe it. We want the providers to want to use it, to trust it, and to believe in it.

So learn about it. Participate. A lot of these digital companies have advisory boards that you can ask to be on. When you get emails or requests for feedback or follow-up, respond, because they’ll listen, because you’re the ones who are writing that prescription.

Kevin Pho: Benjamin, thank you so much for sharing your time and insight, and thanks again for being on the show.

Benjamin Alouf: You’re welcome. Thank you.

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