Christoph U. Correll, MD: Hello, my name is Christoph Correll. I'm a professor of Psychiatry and molecular medicine at the Zucker School of Medicine at Hofstra Northwell in New York. I'm also a professor and chair of the Department of Child and Adolescent Psychiatry at the Charity University in Berlin, Germany. So, what's the ecosystem of patient-facing tools in the digital health technology world?  

We have basically three levels we need to know about. The first one that all of you most likely have been exposed to, and maybe even use yourselves, are wellness and support products that capture, store, or transmit health data. What are these? These are lifestyle apps, activity trackers, medication reminders, wearable and sensors, and also health information collectors. Many of us get every day like, how many steps did you walk today? That can be an incentive to walk more.  

There's a second level, and that is diagnostic and monitoring products. They're used to diagnose, guide diagnoses, or actively monitor patients with their mental or other disorders. These are digital diagnostics or biomarkers; although biomarkers are hard to get by—we are in the process of looking more into that—remote monitoring tools, wearables and sensors, and again, even medication ingestible sensors.  

Finally, we have therapeutic interventions. These are products that deliver medical interventions and therapies. These are called digital therapeutics. They're clinical interventions delivered directly to patients by software to either prevent, treat, or manage a disease or disorder. If you want to learn more about that, go to Psych Congress Network and get some more information.

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Lisa Marsch, PhD: Hi, my name is Lisa Marsch. I'm a professor of psychiatry and biomedical data science at Dartmouth College and the director of the Center for Technology and Behavioral Health at Dartmouth College. Digital therapeutics refers to software that delivers a clinical-grade intervention to prevent, manage, or treat a disease, and within that broader umbrella category of digital therapeutics is something called prescription digital therapeutics. Prescription digital therapeutics is software that clinicians can prescribe in the US. This refers to software that has gone through review at the US Food and Drug Administration and has very clear data from clinical trials showing that it is safe and effective in preventing, managing, or treating a disease or disorder. It requires this FDA clearance in order to be distributed and then prescribed by clinicians in this country, and it requires oversight by health care providers for implementation.  

This slide shows a list of the prescription digital therapeutics that are available right now in the US for the treatment of mental health. As you can see, the very first prescription digital therapeutic that was FDA-authorized in the US was in 2017, and it was specifically for the treatment of substance use disorders. Then, a year later, we saw a new indication for a prescription digital therapeutic for the treatment of opioid use disorder to be used in combination with medication treatment for opioid use disorder.  

Now, we have a growing array of prescription digital therapeutics available for many different mental health conditions, including PTSD, ADHD, insomnia, panic disorder, attention deficit, and, very recently, major depressive disorder and anxiety disorder, and just very recently for, postpartum depression. Many applications are available right now for mental health in the US.

Prescription digital therapeutics have very specific attributes that make them incredibly appealing as resources that clinicians can use in providing care to their patients. First of all, it requires provider oversight—it's prescribable. Clinicians prescribe this to their patients, and this can be prescribed as a standalone treatment or can be used with a whole array of different treatment models, including other types of mental health care, behavioral therapy, and or medication treatment. It requires this regulatory review. There are very specific criteria that you have to achieve in order to get this FDA regulatory clearance showing safety and clinical effectiveness in order to make a claim that this software is effective in preventing, treating, or managing a health condition. They are developed under Good Manufacturing Practices, so they have very strong quality management and are critical and recognized by the World Health Organization. Finally, getting prescription digital therapeutics status increases eligibility for reimbursement and payer coverage by a whole array of different payers, including health insurance companies and other regional health care systems. If you'd like any more information about prescription digital therapeutics, you can go to Psych Congress Network.

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Dan Fulford, PhD: Hi, I am Dan Fulford. I'm a clinical psychologist and associate professor of rehabilitation sciences, occupational therapy, and psychological and brain sciences at Boston University. The breadth and pace of research and development in digital therapeutics have really exploded over the last 10 to 15 years. Between 2010 and 2019, over 500 trials on clinicaltrials.gov were registered with digital in the title, and just since 2020, over 800 trials have ‘digital’ in the title. The area in which we see the most growth and explosion is really in psychiatry. Those trials that are designed to address mental health conditions and mental health needs among people who experience some of these challenges, that's really where we're seeing most of the growth in digital therapeutics.  
 

In order to make a digital therapeutic effective, we really have to use input from those who use the digital therapeutic, those who are clinicians, or those who are actually patients who are potentially benefiting from the digital therapeutic. To do that, we might develop a needs assessment where we understand what the needs are from the patient’s perspective and the provider’s perspective. We use that information to guide the design and development of the initial sort of sketches of what that digital therapeutic might look like. Then we try it out. We figure out what's the best mode of delivery here. What's the right therapeutic? How do we really address the needs of the patient specifically? And how do we improve functionality?  

The input we might get from a patient is around how usable it is and how acceptable the content is to them. The user evaluation process involves this iterative development where we have user testing, we have feedback from the users, and we update the design based on that feedback. We test it again, and we get more feedback on and on and on. Ultimately, the goal is to increase user acceptance with this process. So that's information on digital therapeutics. If you want more information, you can go to Psych Congress Network to find out more.

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Dr Andrew Cutler: Hello. I am Dr Andrew Cutler, clinical associate professor of psychiatry at SUNY Upstate Medical University in Syracuse, New York, and I am the Chief Medical Officer for the Neuroscience Education Institute in Carlsbad, California. And my practice is actually based in Lakewood Ranch, Florida. 

Amber Hoberg: I'm Amber Hoberg. I'm a psychiatric mental health nurse practitioner. I practice at Baptist Healthcare System and Morningstar Family Medicine in San Antonio, Texas. 

Dr Andrew Cutler: So, Amber, as we know, schizophrenia has a very heterogeneous clinical presentation, and of course, we know it also has a heterogeneous neurobiological underpinning. When we talk about the symptoms of schizophrenia, we tend to divide them into a couple of categories. We talk about the positive symptoms, which most people think about when they think of psychosis, and this is hallucinations, delusions, which are false beliefs, hallucinations are false perceptions, and then disorganized thoughts. Next category are negative symptoms, and this can be very impairing to patients. These are things that include alogia, not talking; blunted affect is not showing much expression; not having a lot of social interaction; not having a lot of motivation, which is avolition; and not really being able to express pleasure. Then we have the cognitive symptoms, and of the three domains here, we think cognitive impairment, clearly the most associated with functional impairment. So we look at cognition in seven key domains that can have impairment: Attention and vigilance; reasoning and problem solving, which is part of executive function; social cognition, very important to read social cues; speed of processing, and that's both mental—it's a combination really of mental and physical speed; verbal learning; and memory; and then there's visual learning and memory; and then working memory, which is kind of a shorter term memory to hold something in your memory while you're going to information you want to use soon. 

The positive symptoms, as you can see here, tend to be more overt, and those are the things that get people into trouble acutely. That's, of course, what can lead to hospitalization and so on. However, as we said, our medications can be very effective for the positive symptoms. Unfortunately, the current medications are not as effective for negative symptoms and cognitive impairment. And interestingly, there's similar underlying neurobiology in both the pathways for negative symptoms and cognitive symptoms. And it's not only a similar neurobiological structure, but also similar circuitry and similar neurotransmitters may be involved. 

Amber Hoberg: The interesting thing is a lot of my patients, we can treat the positive symptoms, but negative and cognitive symptoms tend to be a lot harder and something that the patients tend to struggle with that cause a lot of functional problems. 

Dr Andrew Cutler: Well, absolutely. Our current medicines—we all know, we've had a patient or two, we've had some patients who do have some improvement in negative symptoms and cognition, but on average, unfortunately, not enough people are helped. 

Amber Hoberg: Thank you so much for joining and watching today. 

Dr Andrew Cutler: And for more information, please check out Psych Congress Network.