Expert Panel on Digital Therapeutics Presents at ASCP
Woebot Health Vice President, Commercial Tim Mariano, MD, PhD, MSc, SMIEEE, presided over a panel discussion at the American Society of Clinical Psychopharmacology (ASCP) annual meeting in Scottsdale, AZ, in June.
The Topic
Digital Measurement and Therapeutics in the Peri-Pandemic Era: Challenges and Opportunities
The Audience
Academic and industry investigators, research pharmacists, clinicians, and representatives from regulatory agencies
The Panel
- C. Neill Epperson, MD: Robert Freedman Endowed Professor and Chair of the Department of Psychiatry in the School of Medicine, University of Colorado Anschutz Medical Campus
- Georgia Mitsi, PhD: GM Mental Health & VR Solutions, Biogen Inc.
- Ellen Frank, PhD: Distinguished Professor Emeritus of Psychiatry and Psychology, University of Pittsburgh School of Medicine; Co-Founder and CSO, HealthRhythms, Inc.
- Alison Darcy, PhD: Founder and President, Woebot Health
Discussant
- Justin Baker, MD, PhD: CSO, Mindstrong; Scientific Director, McLean Institute for Technology in Psychiatry; Director, Laboratory for Functional Neuroimaging and Bioinformatics, McLean Hospital; Assistant Professor of Psychiatry, Harvard Medical School
Chair
- Dr. Mariano, in addition to his role at Woeboth Health, is Associate Investigator, Center For Neurorestoration & Neurotechnology (CfNN), VA Providence Healthcare System; Adjunct Assistant Professor, Warren Alpert Medical School of Brown University
Why did you decide to create this panel and tackle this topic?
There is a shift in how medical care in general and mental healthcare specifically is being delivered. We’re moving away from the approach in which someone is prescribed an SSRI or SNRI and takes it every day indefinitely, or someone is engaged in psychodynamic psychotherapy for 50 minutes a week indefinitely. And we are seeing new approaches that leverage technology and non-traditional forms of interaction that might be briefer or at different times than say, typical weekly psychotherapy. These approaches have the potential to be highly beneficial to patients in a number of ways.
How so?
They offer a degree of individualization, allowing us to meet patients where they are. Sensors, for example, may indicate when someone might be having worsened or increased symptoms more quickly than subjective rating scales. And an app that delivers cognitive behavioral therapy (CBT) can be used at 3 in the morning, when a therapist may not be available. All of this allows us to intervene earlier before someone’s really doing badly and that’s the gold standard of patient-centered care.
But we also need to be mindful that it’s not a one-size-fits-all approach. Instead, we want to grow the toolbox to include more precision tools.
What did each panelist bring to the discussion?
The goal was to have a variety of viewpoints.
First, we wanted to lay the groundwork for why it’s important. Speaking from the standpoint of a medical system that is very proactive in vetting and using these tools, Dr. Epperson laid out ways that app-based approaches or apps are already being used to improve mental health in actual clinical populations. She explained that tech, everything from telemedicine to apps such as Woebot, can not only help meet some of the vast need for care but in some cases, improve the patient experience by offering more options and continuous care.
Dr. Mitsi, who vets these types of technologies for Biogen, brought an industry perspective. Even though a pharma company may not be developing a digital therapeutic specifically, digital biomarkers, or behavioral biomarkers, are of interest because they might have the potential to show response/nonresponse on a shorter time scale or show changes earlier than the rating scales pick them up.
The two final panelists provided examples of actual digital measurement and therapeutic solutions.
Dr. Frank spoke about the potential of smartphones to provide continuous and objective measurement of patient behavior.
Her company makes a smartphone-based precision digital intervention for depression based on social rhythm regulation principles. It uses GPS, the accelerometer, and other sensors built into the phone to passively continuously monitor a patient’s actions. Based on that sensed data, it provides in-the-moment micro-interventions to help regulate the patients’ routines and ultimately their mood.
Dr. Darcy brought an example of software as a medical device (SaMD), a digital therapeutic. She talked about how Woebot Health is currently working to get FDA clearance for a prescription digital therapeutic to treat postpartum depression. The app engages users in a text-based chat with a relational agent called Woebot, who guides them through CBT treatments for PPD in moments of need.
Study results presented by Dr. Darcy show that users actually bond with Woebot, even though it is an AI–something previously thought only possible between humans. While another study she cited shows that participants, who were in the 6-week postpartum period, showed high satisfaction with and acceptability of a smartphone-based automated conversational agent.
What did you find interesting or surprising?
Learning about the Zeitgeber theory, which Dr. Frank actually came up with, with others, in the late ’80s. They wrote about how the disruption of social rhythms, which may result in instability in biological rhythms, could be responsible for triggering the onset of a major depressive episode in vulnerable individuals. She gave the example of jet lag. You’re feeling tired at the wrong time, hungry at the wrong time, and probably a bit more irritable or less attentive. The end path of this sort of disruption, if untreated, can be a mood disorder episode. It’s not new, but it was new to me and really interesting.
What are some of the big challenges that were discussed?
How do we regulate digital tools in an effective way that works for both the end-user, as well as the producers of these devices? With digital therapeutics, there needs to be a way to update and improve it, especially if you’re using machine learning approaches, which require retraining data sets. You don’t have that with a drug. You don’t change the molecule after it’s approved. So how do you maintain that degree of oversight to make sure there isn’t a slip in quality or any other concern? There needs to be some continual vetting or re-certification–ideally through a regulatory agency. Presently they’re not equipped for that kind of continual/rapid turn-around. So a shift in approach and thinking is also needed.
Then, let’s say you have a digital therapeutic that is cleared by FDA and is prescribable by a physician. How do you integrate this into existing clinical workflows? Are there billing codes to support the manners in which a digital therapeutic is used?
Also, there’s this idea that a digital approach will supplant humans. Dr. Epperson pointed out that people once believed that CT scans would destroy the clinical aspect of neurology. We have to accept the technology and adapt. For the foreseeable future, there’s always going to be a need for human therapists and psychiatrists. Even with something like Woebot, where it’s an AI solution, there are still humans in the loop at some point. A human wrote the text. A human designed the logic flow. There was still human input. And Dr. Darcy made the point that Woebot is complementary and has been widely used as an adjunct to traditional psychotherapy.
I think there are a lot of options about how to loop in humans and where, but it’s going to vary by the patient population, how sick they are, the diagnosis, the severity of diagnosis, and what the app is trying to do. There are going to be different answers for different apps in different subpopulations of users, too.
Some patients and some cases will require human interaction. But there is also a whole swath of people for whom a few minutes several times a week with an app will be what is needed for them to maintain a state of wellness. It’s not a one-or-the-other type of situation.
Nor is it, a one-size-fits-all approach. We need to have a broad range of tools that together can cover the whole spectrum of mental health needs efficiently, so people aren’t waiting months to see a therapist or a psychiatrist, which is the case right now.
