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Yale Psychiatry Grand Rounds: "Transforming Mental Health Care via Science-Based Digital Therapeutics"

February 02, 2024
  • 00:00It's just a, it's just an honor
  • 00:03to be here and to join all of you.
  • 00:05And I have so many wonderful friends
  • 00:07and colleagues at Yale and I see
  • 00:09some familiar names here and very
  • 00:11excited to be with you all today.
  • 00:12So I'm going to go ahead and
  • 00:15share my screen here.
  • 00:19So as you heard,
  • 00:20I'm going to be talking about digital
  • 00:23health as applied to mental health.
  • 00:25And I know several of you on this
  • 00:28call are working in this space and
  • 00:31doing really pioneering work and
  • 00:33exciting work in this space.
  • 00:35And really excited to have a
  • 00:37continued dialogue at the end of
  • 00:39this lecture today and and hear what
  • 00:41questions and comments you have,
  • 00:42but also to learn more about what
  • 00:43you all are building in this space.
  • 00:45And I'm going to talk today about
  • 00:46just sort of where we are in terms
  • 00:48of the state of the science of
  • 00:50applying digital health to mental
  • 00:52health and addiction and give you
  • 00:54a snapshot of sort of the scope
  • 00:56of the science and how we can
  • 00:58implement these tools in real,
  • 00:59real world settings to really
  • 01:01transform models of care.
  • 01:03And then I'll tell you a little bit
  • 01:04more about our Research Center.
  • 01:05We have an Ida funded center as
  • 01:08Stephanie mentioned that's entirely
  • 01:09focused on the application of
  • 01:11digital health to to the realm of
  • 01:13addiction and and mental health.
  • 01:15And we have a lot of resources
  • 01:16and and and opportunities for
  • 01:17collaboration and and if anyone here
  • 01:20is interested in exploring that more,
  • 01:21we would be just delighted to do so.
  • 01:25So in first I want to acknowledge
  • 01:27some of the funding that I'll be
  • 01:28referencing in our work today,
  • 01:30including our center grant from the
  • 01:32National Institute on Drug Abuse as
  • 01:34well as several other NIH grants.
  • 01:36I'll be showing some data from today.
  • 01:40And then I also wanted to acknowledge
  • 01:42that in addition to my academic
  • 01:45affiliation at Dartmouth College,
  • 01:46I also have an affiliation with a
  • 01:48few small businesses that are working
  • 01:50in the digital health space as well
  • 01:52as Burying or Ingelheim that's
  • 01:53working in the digital health space.
  • 01:55And I'll tell you a bit more
  • 01:56about our center at the end.
  • 01:57But you know,
  • 01:58although we are a Research Center
  • 01:59and really focused on bringing
  • 02:01science to the space of digital health,
  • 02:03we are really building out strategic
  • 02:06partnerships to scale the best,
  • 02:08most potent and engaging digital
  • 02:10health tools and doing that in
  • 02:12a strategic way with partners.
  • 02:13And I'll tell you a bit more about that.
  • 02:17So just starting with terminology,
  • 02:20so digital health is a term that you
  • 02:22probably are hearing more and more
  • 02:24of it's it's increasingly a a a key
  • 02:26part of many models of healthcare.
  • 02:27And you know I'm convinced that undoubtedly
  • 02:29it's a a a very key part of the future
  • 02:32of how we're going to see healthcare
  • 02:34delivery particularly in mental health.
  • 02:36So I think it's really critical that
  • 02:38we sort of embrace and understand it.
  • 02:41It's it's going to be a key part of the
  • 02:42work that we also do together as well
  • 02:44as the next generation of clinicians
  • 02:45and and and healthcare providers.
  • 02:48So digital health is a is a term
  • 02:50that often refers to using digital
  • 02:52technology not unlike a a smartphone
  • 02:54that's within arm's reach of most of us,
  • 02:57most of the most moments of the
  • 02:59day to do a few things.
  • 03:00One is to get new insights into people's
  • 03:03health behavior in their daily life.
  • 03:05And then also you can use these types of
  • 03:08digital platforms to provide therapeutic
  • 03:11tools to people anytime and anywhere.
  • 03:14And this is a term called
  • 03:15digital therapeutics.
  • 03:16And I'm going to spend some time talking
  • 03:18about what that means and what these
  • 03:19are and what kinds of clinical effects
  • 03:21we can see with these types of tools.
  • 03:23So it's really around using
  • 03:25digital technology for assessment
  • 03:27and for therapeutic delivery,
  • 03:28which can be quite personalized
  • 03:32and and also widely accessible.
  • 03:35So starting with this term,
  • 03:36digital therapeutics,
  • 03:37this is a term that refers to software
  • 03:43that is effective in preventing,
  • 03:45treating or managing a health condition.
  • 03:47So it's a clinical grade
  • 03:50intervention delivered via software.
  • 03:52So it's it's sort of going above
  • 03:54and beyond what we think of as
  • 03:55health promotion or Wellness apps.
  • 03:57And you're taking the active therapeutic
  • 03:59ingredients of a clinical intervention
  • 04:01and delivering it through the
  • 04:04functionality and the content of software.
  • 04:06So I'll give you any examples in the
  • 04:09talk today, but this could include,
  • 04:10for example,
  • 04:11cognitive behavioral types of
  • 04:13interventions that are entirely
  • 04:15delivered through software.
  • 04:16So this is not telehealth,
  • 04:17but it surely can complement and
  • 04:19extend what we do with telehealth.
  • 04:20But as we know with telehealth,
  • 04:21we have synchronous communication
  • 04:23with the clinician and this is
  • 04:25something that's accessible anytime,
  • 04:27anywhere 24/7,
  • 04:28kind of like a clinician in your pocket,
  • 04:31but you know,
  • 04:33but that is available on demand and
  • 04:36perhaps at at times of greatest need.
  • 04:39And so you're packaging this model of care
  • 04:41into the seamless digital delivery platform.
  • 04:44And there are a number of benefits
  • 04:46of this approach and we've surely
  • 04:48seen this play out in the data.
  • 04:50So first of all,
  • 04:51these types of tools can extend the
  • 04:53reach and the impact of clinicians,
  • 04:55right.
  • 04:56These can be additional tools in the
  • 04:58toolbox of clinicians that can sort of
  • 05:01supercharge our clinician workforce
  • 05:02and extend their reach and provide
  • 05:04resources to people even when they're
  • 05:06not working with their clinicians.
  • 05:08So it can reinforce and
  • 05:10extend the work that you
  • 05:12might be doing with the clinician
  • 05:14and and and I'll show you data,
  • 05:16but we've definitely seen now across many,
  • 05:18many health domains,
  • 05:19particularly mental health.
  • 05:20Much of this work to date has been
  • 05:22in the realm of mental health,
  • 05:24although there are many growing
  • 05:27applications in a wide array of
  • 05:29aspects of preventative health
  • 05:30to chronic disease management.
  • 05:33But we have seen very robust and
  • 05:35replicable effects on all kinds of
  • 05:38health behavior and health outcomes.
  • 05:40We can be assured that these
  • 05:43tools can deliver interventions
  • 05:44with fidelity to best practices.
  • 05:47So this can be treatment interventions,
  • 05:48this can be prevention interventions
  • 05:50and we can really ensure that we
  • 05:53are delivering this with reflecting
  • 05:54sort of state of the science
  • 05:56models of intervention delivery.
  • 06:00And surely we know that not everybody in
  • 06:03the world yet has access to digital devices.
  • 06:06All the all the data, all the trends
  • 06:08show that the majority of the world's
  • 06:11population either has access now to
  • 06:13mobile devices and or is expected to
  • 06:16get access to these mobile devices.
  • 06:18And we we work with all kinds of populations
  • 06:20in this country including some you know,
  • 06:22traditionally underserved
  • 06:23populations in this country.
  • 06:25But we also do a lot of work
  • 06:26in other parts of the world,
  • 06:27low and middle income countries and you know,
  • 06:30we might work with communities that
  • 06:32don't have clean water or you know,
  • 06:33a landline infrastructure but
  • 06:35often have a mobile device.
  • 06:37And so it's an it's an amazing opportunity
  • 06:39to harness the widespread availability
  • 06:42and growing availability of these types
  • 06:44of tools to give people resources,
  • 06:47healthcare resources in new ways
  • 06:49through these types of platforms.
  • 06:52It's scalable.
  • 06:52I think that's one of the most
  • 06:54exciting things is that you can
  • 06:56have really widespread reach and
  • 06:57impact with these types of tools.
  • 06:59And as you all know very well,
  • 07:01during the the COVID crisis,
  • 07:03we definitely saw a big surge in
  • 07:05demand for remote models of care and
  • 07:08that definitely included telehealth.
  • 07:09But we also saw,
  • 07:10and I'll tell you a bit more
  • 07:12about this later,
  • 07:13a big growth in demand for
  • 07:15these types of digital tools,
  • 07:17digital interventions.
  • 07:20And as I mentioned,
  • 07:21we see we can get a big impact on on
  • 07:24lots of different health outcomes,
  • 07:25including health costs.
  • 07:27And there's some striking data
  • 07:28including some recently released data
  • 07:30that really showed not only can this
  • 07:32impact people's lives and their functioning,
  • 07:35but can have huge implications
  • 07:38to healthcare expenditures.
  • 07:40So these are some of the the benefits of it.
  • 07:42And this slide is just a snapshot
  • 07:44of sort of the state of research
  • 07:47in the application of digital
  • 07:49therapeutics to behavioral health.
  • 07:50And we've been,
  • 07:51I've been doing this work for decades now.
  • 07:54And but there's, you know,
  • 07:55really decades of of really
  • 07:57robust literature focused on,
  • 07:59you know,
  • 08:00how do you best develop and and
  • 08:02test and implement and sustain these
  • 08:04types of tools to really have value.
  • 08:06And this slide sort of gives you the
  • 08:08big picture of that body of of research.
  • 08:10And So what we generally see in the
  • 08:13literature is that if you develop
  • 08:14these tools, well development's huge,
  • 08:17it's it's really huge.
  • 08:19We could spend a lot of this time just
  • 08:21talking about development in terms
  • 08:22of how do you really develop a tool that is,
  • 08:24you know,
  • 08:25reflective of of the needs and and
  • 08:27cultures and values and and and brings
  • 08:29clinical utility to your target audience.
  • 08:32But if you embrace sort of best
  • 08:34practices and really have something
  • 08:35of value to to your target audience,
  • 08:38we see that these tools can be
  • 08:40highly useful and acceptable to
  • 08:42lots of different populations.
  • 08:44We see we can have a very large
  • 08:46impact on a wide array of health
  • 08:49behaviors and health outcomes.
  • 08:50We also have seen now in many studies
  • 08:53that digital interventions can produce
  • 08:56outcomes that are as good as or better
  • 08:59than clinician delivered interventions.
  • 09:01And you know some people you know
  • 09:02sort of bristle at that and and
  • 09:04worry that we're trying to replace
  • 09:05clinicians with these types of tools.
  • 09:07But as you all know very well in the
  • 09:09work that that you do you know it
  • 09:11we really have a capacity challenge
  • 09:13in many pockets of the world in
  • 09:15terms of you know really having
  • 09:17sufficient mental health workforce
  • 09:19to meet our population level needs
  • 09:21or or addiction treatment workforce
  • 09:22to meet our population level needs.
  • 09:24And so it's it's I,
  • 09:26I think of great value to know that
  • 09:28the data support that these types
  • 09:30of digital tools can really produce
  • 09:32meaningful clinical effects that can
  • 09:35extend the workforce that we have
  • 09:37and can help increase capacity and
  • 09:40reach for prevention and treatment
  • 09:43of various health conditions.
  • 09:45We've also seen you can increase reach,
  • 09:47you can increase personalization of care.
  • 09:49I'll talk a bit more about some
  • 09:50of the economic data,
  • 09:51but now there's a growing body of
  • 09:54literature showing economic benefits and
  • 09:56these don't always have to work the same way.
  • 09:58It doesn't have to be 8 sessions of 1
  • 10:00intervention or 12 sessions of another.
  • 10:02You can really embrace what technology
  • 10:04can do and have very adaptive types of
  • 10:08interventions that can change over time,
  • 10:11that can be very personalized to
  • 10:13whatever an individual's needs
  • 10:14and preferences are in the moment.
  • 10:15But that can again be adoptive in
  • 10:17an ongoing way as people's clinical
  • 10:19trajectories and needs change over time.
  • 10:22And there's a lot of exciting
  • 10:23research in that space,
  • 10:24including in our center and I'll
  • 10:26I'll speak a bit about that.
  • 10:27But I think that's,
  • 10:29I think that we have a lot of
  • 10:31promise for precision interventions,
  • 10:33precision delivery of mental health
  • 10:36interventions delivered anytime and
  • 10:39anywhere through capture of digital
  • 10:41data at the individual level and
  • 10:43then very responsive interventions
  • 10:45provided on digital platforms.
  • 10:49I'm going to talk about, first of all,
  • 10:52I'm going to talk about a
  • 10:53digital intervention that we did.
  • 10:55We developed the first iteration of
  • 10:56a long time ago, actually the first,
  • 10:58first iteration of it was in
  • 10:59the late 90s and it was not,
  • 11:01it was web-based at the time and not
  • 11:03a mobile intervention at the time and
  • 11:05has evolved over that period of time.
  • 11:08But I talk about this as an
  • 11:10exemplar of a digital therapeutic,
  • 11:12just to highlight what one
  • 11:13of these can look like,
  • 11:14but also what kinds of clinical
  • 11:16effects you can see when you
  • 11:18use these tools different ways.
  • 11:20So I'm going to give you examples
  • 11:22of different ways you could
  • 11:23apply this type of approach,
  • 11:25But I know there are many others.
  • 11:26In fact, Yale, you know,
  • 11:27has developed fantastic tools in the space,
  • 11:30including CBT for CBT,
  • 11:31and there are many others for
  • 11:33substance use and for mental health.
  • 11:35So this is just an example.
  • 11:37And briefly,
  • 11:38this is a pretty intensive behavioral
  • 11:42treatment for substance use disorders
  • 11:45that's entirely delivered in this
  • 11:48interactive self-directed way.
  • 11:49Again started web-based and then
  • 11:52morphed into a a mobile tool.
  • 11:54It just briefly I'm not going to
  • 11:57talk about the details of this.
  • 11:59I'm happy to chat more about this
  • 12:00if folks have specific questions.
  • 12:02But this takes one of our very
  • 12:04potent behavioral treatments for
  • 12:06substance use disorders called the
  • 12:08community reinforcement approach
  • 12:09to substance use disorder treatment
  • 12:12and takes the active ingredients
  • 12:13of that therapeutic approach and
  • 12:15delivers it on a digital platform.
  • 12:17So it's very interactive at
  • 12:20the individual level.
  • 12:21It focuses on helping people understand
  • 12:24their specific sort of pattern of
  • 12:27of behaviors of cognitions that
  • 12:29maintain self defeating patterns or
  • 12:30drug taking behavior and how you can
  • 12:33understand and disrupt those patterns.
  • 12:35And and and develop a new skill set
  • 12:36and a new behavioral repertoire that
  • 12:38can help you initiate and maintain a
  • 12:40recovery process and how to leverage
  • 12:43different resources in that process.
  • 12:46And there is an optional piece
  • 12:48to this intervention that is
  • 12:50motivational incentives piece,
  • 12:51which is often called contingency
  • 12:54management where you give people incentives,
  • 12:57prizes, rewards,
  • 12:58contingent on different milestones,
  • 13:00different successes in a recovery
  • 13:01process in this case.
  • 13:02And that that's all automated
  • 13:04in this tool and is an optional
  • 13:06component of this broader platform.
  • 13:09So again, happy to talk about this more,
  • 13:10but just just wanted to give you
  • 13:12a snapshot of what this is it.
  • 13:14It,
  • 13:14it's not just about sort of
  • 13:15enhancing motivation to change.
  • 13:16It really is intended to be an
  • 13:19intensive behavioral treatment
  • 13:20that that really helps people
  • 13:22build the skills and capacity for,
  • 13:25for change,
  • 13:26particularly around substance use.
  • 13:28So what I'm going to do now is just
  • 13:30give you a little bit of data and
  • 13:32some examples of the kinds of effects
  • 13:34you can see with these types of tools.
  • 13:37So one of the really early studies
  • 13:40that we did was I'll just briefly
  • 13:42describe the study and I'll mention
  • 13:43that we have lots and lots
  • 13:45of papers on all of this.
  • 13:46So if anyone has any interest,
  • 13:48please reach out.
  • 13:49I have my e-mail address on the last slide,
  • 13:52Please reach out and I'm happy
  • 13:53to share any and all additional
  • 13:55information that might be useful.
  • 13:57But in the interest of time I'm
  • 13:59just going to sort of give you a
  • 14:01flavor of of some of this work.
  • 14:02So, so this is this particular trial
  • 14:05Nida funded study was a three arm
  • 14:07randomized clinical trial and these
  • 14:09were all adults entering outpatient
  • 14:11treatment for opioid use disorder.
  • 14:14And every every single participant
  • 14:16in the study received medication.
  • 14:19We all know that medication is a
  • 14:21critical component of effective
  • 14:22treatments for opioid use disorder.
  • 14:24This is a sample here that all received
  • 14:28buprenorphine medication as part of care.
  • 14:31But the randomization occurred on the
  • 14:33type of behavioral treatment that people
  • 14:35received on top of the pharmacotherapy.
  • 14:37So if you went into the condition that
  • 14:40is reflected in the blue column here,
  • 14:43you were randomly assigned to a therapist
  • 14:45and you met with this therapist three
  • 14:47times a week in individual sessions.
  • 14:49And this therapist delivered to
  • 14:51you the community reinforcement
  • 14:53approach to behavior therapy for
  • 14:55substance use disorder treatment.
  • 14:57And there were all kinds of fidelity
  • 14:59checks in place to make sure it
  • 15:00was being done in accordance with
  • 15:02sort of state of the science
  • 15:03approach to this therapeutic model.
  • 15:04And so it was a pretty intensive one-on-one
  • 15:08therapeutic approach with a clinician.
  • 15:10If you went into what's
  • 15:12reflected in the red column here,
  • 15:14you had a therapist and you saw them
  • 15:16every other week just to check in.
  • 15:18But your, your therapy,
  • 15:19therapy was offloaded to a
  • 15:22digital delivery platform.
  • 15:23So this is a group that in this
  • 15:26particular study actually went to a
  • 15:28computer lab on site at the treatment
  • 15:30facility and interacted 3 * a week
  • 15:33with a digital version of this
  • 15:36community reinforcement approach,
  • 15:38behavioural therapy approach.
  • 15:39And then if you went into what's
  • 15:42reflected here in the Gray column,
  • 15:43you received what was considered
  • 15:46treatment as usual standard treatment
  • 15:48for opioid use disorders in the
  • 15:50US at the time and it wasn't the
  • 15:53community reinforcement approach.
  • 15:54So basically this slide shows that
  • 15:56even when you offload the bulk of this
  • 15:59therapeutic approach to a digital platform,
  • 16:01you can get comparable clinical
  • 16:03outcomes to what you observe from
  • 16:06exclusively clinician delivered care.
  • 16:08And then both versions of this
  • 16:10you know very effective and potent
  • 16:13behavioral therapy produce better
  • 16:15outcomes than our standard treatments.
  • 16:17And this particular slide is on a
  • 16:20objectively captured data through
  • 16:22urine toxicology testing looking
  • 16:24at abstinence from opioids and
  • 16:26cocaine in the sample.
  • 16:27So.
  • 16:27So that was one example of a way that
  • 16:30you could apply this and and and
  • 16:32you can see the kinds of benefits
  • 16:34you get clinically from that.
  • 16:36But now I'm going to show you
  • 16:37different examples.
  • 16:37So this was a study that we did
  • 16:40in New York City and
  • 16:42these were all adults again with
  • 16:44opioid use disorder that were
  • 16:46entering outpatient treatment.
  • 16:48This was done in methadone treatment
  • 16:51systems and when people came in
  • 16:53to treatment they either received
  • 16:56treatment as usual in methadone
  • 16:58treatment setting which as you
  • 17:00likely know includes daily methadone
  • 17:03medication and some therapy support
  • 17:06from counselors in the system.
  • 17:08So they went either into that
  • 17:10condition or they were randomized to
  • 17:12this condition which was basically
  • 17:15a condition where they they they
  • 17:18they had daily methadone access,
  • 17:20they had a clinician.
  • 17:21But the only difference between
  • 17:23the two conditions is that in
  • 17:24the one reflected here in blue,
  • 17:26those participants had a therapist
  • 17:30but their clinician patient time
  • 17:32was cut in half and the other half
  • 17:35of that time was spent interacting
  • 17:38with the digital therapy.
  • 17:40So let's say instead of doing a 60
  • 17:42minute session with their counselor,
  • 17:43they did a 30 minute session with
  • 17:45their counselor and then they
  • 17:46interacted for the rest of 30 minutes
  • 17:48in this interactive one-on-one
  • 17:49way with this digital treatment,
  • 17:51this community reinforcement
  • 17:53approach treatment.
  • 17:54And what we find is that when
  • 17:56you cut in half patient clinician
  • 17:58contact time and replace it with
  • 18:00this digital intervention,
  • 18:01we had significantly greater
  • 18:04documented abstinence from opioids
  • 18:06in that sample versus the sample who
  • 18:10received standard methadone treatment.
  • 18:13We had the opportunity in this study,
  • 18:14this was Nida funded.
  • 18:16We had the opportunity to track these
  • 18:19outcomes for 12 months per participant
  • 18:22and the differential here you see
  • 18:24persisted for that 12 month window.
  • 18:27We saw this benefit from including
  • 18:29the digital treatment as part of the
  • 18:32care model and there's lots to say
  • 18:33about why we think this is the case.
  • 18:35But you know this is an intervention
  • 18:37that you know is being delivered
  • 18:39with fidelity every time and
  • 18:40it's very responsive to what
  • 18:42people are understanding or not,
  • 18:44what their needs are or not.
  • 18:45So it's very personalized in the way
  • 18:47that it delivers the interventions
  • 18:49to a a particular individual.
  • 18:51And and we know there's a
  • 18:53lot of variability right, in,
  • 18:54in terms of what happens in counselling
  • 18:56in different in therapeutic settings.
  • 18:58And so this is very encouraging that this
  • 19:01can really have this kind of robust effect.
  • 19:05And then one more snapshot,
  • 19:07There's lots more data to
  • 19:08share beyond these studies,
  • 19:10but one more snapshot just to
  • 19:11show you a different way that a,
  • 19:13a clinical setting could embrace
  • 19:15a digital therapeutic.
  • 19:16And that is to say, OK,
  • 19:18we're not going to touch the
  • 19:19underlying model of care.
  • 19:19We're just going to add this
  • 19:21on as a supplement.
  • 19:21We're going to say over and above our
  • 19:23treatment as usual our care model.
  • 19:26What if we offered a digital intervention
  • 19:28as an adjunct to care and that's
  • 19:31what's reflected in this study.
  • 19:33So again,
  • 19:34this is another study with
  • 19:36adults with opioid use disorder
  • 19:38entering outpatient treatment.
  • 19:40This is another study in a
  • 19:42methadone treatment setting.
  • 19:43And the participants either again
  • 19:45receive standard methadone treatment or
  • 19:48as an adjunct to that they were
  • 19:50given when they joined the study,
  • 19:52access to a mobile version
  • 19:54of this digital intervention.
  • 19:56And when you gave folks this
  • 19:58mobile version on top of the
  • 20:00underlying treatment model,
  • 20:01we were able to keep those
  • 20:03people in treatment much longer,
  • 20:05much higher percent of those people
  • 20:07retained in treatment compared to
  • 20:09those who received standard treatment.
  • 20:10So right now we're looking at
  • 20:12what happens in the first three
  • 20:14months of your treatment episode.
  • 20:16And we found much higher percent of
  • 20:18patients who got the app as part of
  • 20:21care were retained in that window
  • 20:22of time versus those who didn't.
  • 20:24And you know, this is really important.
  • 20:26We know that treatment retentions are really.
  • 20:28Important predictor of all kinds
  • 20:30of other clinical outcomes in
  • 20:31substance use treatment.
  • 20:33And if we can bump up and and you know,
  • 20:35increase our retention,
  • 20:36particularly in these early windows,
  • 20:39you know of when dropout can be quite high,
  • 20:42you know this can be a
  • 20:43really meaningful effect.
  • 20:44And the same pattern I'm showing
  • 20:45you here showed up in the urine
  • 20:48toxicology data where if you offered
  • 20:50this mobile tool as part of treatment,
  • 20:52you had more documented abstinence
  • 20:55from opioids than if you didn't.
  • 20:58And again,
  • 20:59I'm just giving you examples of data there.
  • 21:01There's lots of really compelling
  • 21:04literature on the on the utility,
  • 21:06clinical utility of these types of
  • 21:08tools for substance use disorder
  • 21:10but also for other types of mental
  • 21:12health conditions.
  • 21:13And I I just wanted to mention this is
  • 21:16something that if you are a clinician,
  • 21:18if you don't know about this,
  • 21:19you you should because it's undoubtedly
  • 21:21a big part of of what is going to be
  • 21:24a part of our future of healthcare.
  • 21:26And surely you know our our
  • 21:27residents and then the trainees,
  • 21:29medical students should should
  • 21:30surely be aware of this.
  • 21:31So it's the case now in this country
  • 21:34that software can be prescribed by
  • 21:37doctors and there's a there's a
  • 21:39category of medical devices that
  • 21:42the US Food and Drug Administration
  • 21:44calls software as a medical device
  • 21:47where you can go to the FDA with
  • 21:49data from a clinical trial seeking
  • 21:52a label saying this software is
  • 21:54effective in the prevention,
  • 21:56treatment or management of some
  • 21:58disease or disorder.
  • 21:58And you have to meet a lot of
  • 22:00different requirements.
  • 22:01But if you if you meet the
  • 22:03requirements and and you get sort
  • 22:05of authorization for that,
  • 22:07for that claim,
  • 22:08you become what's called a prescription
  • 22:11digital therapeutic and that software
  • 22:13is an eligible to be prescribed
  • 22:16by clinicians in this country.
  • 22:18And the first time that happened
  • 22:20was in 2017 and that happened to be
  • 22:24a this computerized intervention
  • 22:26I just described to you for this
  • 22:29community reinforcement approach
  • 22:31to behaviour therapy for substance
  • 22:33use disorders.
  • 22:33And then the second one which was
  • 22:36FDA cleared in 2018 was a specific
  • 22:39indication of that intervention for
  • 22:41treatment of opioid use disorder.
  • 22:43Now we have a growing array of
  • 22:46digital therapeutics that
  • 22:47are available for prescription.
  • 22:49Most of them are in the mental health space,
  • 22:51not all and one includes a
  • 22:55pediatric indication for ADHD.
  • 22:57So again FDA is not going to look at your,
  • 23:00your your software if it's if it's
  • 23:03a general Wellness app or a health
  • 23:05general health promotion type of tool.
  • 23:08Those are excluded from regulatory oversight.
  • 23:09But it really has to be you know,
  • 23:11software driven,
  • 23:12evidence based and seeking to make a
  • 23:14claim of this is a potent intervention.
  • 23:16Some people call these digital pills.
  • 23:19So you know, there's been a lot of
  • 23:22excitement around this evolution in in
  • 23:25the regulatory space and there are other,
  • 23:27I'll speak later,
  • 23:28there are multiple other paths
  • 23:29to deployment as well.
  • 23:30But what we have seen, you know,
  • 23:32having worked in this space for a
  • 23:33long time and having clinicians come
  • 23:35to us and say I'm excited about this,
  • 23:36I'm excited about the data,
  • 23:37my patients are interested in this,
  • 23:39What should I offer?
  • 23:40If I go to the App Store,
  • 23:42there are huge numbers of mental
  • 23:43health apps out there.
  • 23:44How do I navigate that?
  • 23:45How do I know what's effective,
  • 23:46what's not,
  • 23:47what could be harmful.
  • 23:48And so there are there are multiple
  • 23:50ways to do that.
  • 23:51But one benefit of this particular
  • 23:53pathway is that you know if something
  • 23:56has gotten this designation by
  • 23:58FDA that it's really you know,
  • 24:00been carefully vetted and really you know,
  • 24:03had to meet all kinds of criteria
  • 24:05to say indeed this is you know,
  • 24:07safe and effective in preventing,
  • 24:08treating or managing a health condition.
  • 24:10So this is a growing, growing area,
  • 24:12rapidly growing area.
  • 24:14But I just want to tell you that you
  • 24:16know I I've highlighted some examples
  • 24:18of digital therapeutics in the realm
  • 24:19of substance use disorder treatment.
  • 24:21But we have all kinds of examples
  • 24:23now of robust clinical effects
  • 24:24for lots of health conditions,
  • 24:26heavily mental health.
  • 24:27So we've seen as you see here on the
  • 24:30side decreases in mental symptoms
  • 24:32in things like ADHD, anxiety,
  • 24:35depression, PTSDOCD, schizophrenia.
  • 24:37We've seen you can improve remission
  • 24:40rates in in some types of mental health.
  • 24:43We've done a number of studies with
  • 24:46chronic pain patients and you know,
  • 24:49giving people a digital tool to
  • 24:51help them better manage chronic
  • 24:53pain and to help prevent chronic
  • 24:55pain from ruining their lives,
  • 24:56ruining their relationships,
  • 24:57preventing them from achieving goals
  • 25:00and and giving them resources and to
  • 25:02help them help them in these areas.
  • 25:04And what we find is that you know we
  • 25:06can not only improve pain management
  • 25:08and sort of goal directed activity
  • 25:10among chronic pain patients.
  • 25:12So we've also seen that we can
  • 25:13reduce Ed visits, right.
  • 25:14So when you have something in your
  • 25:15pocket that in the moment can help you,
  • 25:17when maybe you're catastrophizing about pain,
  • 25:20perhaps that tool can help you
  • 25:21instead of you know needing to go to
  • 25:24the Ed as as the response to that.
  • 25:25And so you know surely there
  • 25:28this could reduce cost
  • 25:30of of healthcare utilization
  • 25:32including Ed visits.
  • 25:34And we've also seen some really
  • 25:36compelling data in reducing
  • 25:38healthcare costs for panic disorder,
  • 25:39substance use disorder
  • 25:40and opioid use disorder.
  • 25:41For example,
  • 25:43Mass Health Massachusetts Medicaid
  • 25:47just recently published data with
  • 25:51these tools that I just described
  • 25:53for treating digital therapeutics
  • 25:54for treating substance use
  • 25:56disorder that they used with their
  • 25:58first cohort of patients in the
  • 26:00state who got access to those.
  • 26:02And they showed that they dropped Ed
  • 26:04utilization by 45% with when these
  • 26:07tools were part of care models and
  • 26:09they dropped hospitalizations by 64%.
  • 26:11Very compelling data.
  • 26:12I was very excited to see it.
  • 26:15You know this is in the real world
  • 26:17where things are is in the wild what,
  • 26:18what kinds of clinical effects you
  • 26:20can see but also economic effects.
  • 26:22And we've seen also another
  • 26:24application of these types of
  • 26:25tools is in promoting medication
  • 26:27adherence and also adherence to
  • 26:29various types of medical regimen
  • 26:31and then also functional outcomes,
  • 26:34you know,
  • 26:35really helping people have meaningful lives.
  • 26:37So this is just a snapshot of
  • 26:40what's evolving in this space.
  • 26:41There's a lot of exciting work in
  • 26:43the prevention space and really
  • 26:45you know really robust effects in
  • 26:47in building up protective factors
  • 26:48and reducing risk factors for
  • 26:50lots of health conditions,
  • 26:52mental health,
  • 26:53substance use as well as chronic
  • 26:56disease management.
  • 26:58So I think it's a really interesting
  • 27:00time of opportunity.
  • 27:01I've been doing this for a long
  • 27:03time and you know I have seen a
  • 27:05whole confluence of factors recently
  • 27:07that I'm pretty excited about that
  • 27:09I think positions us as a field to
  • 27:12really envision and help shape I
  • 27:15think a very promising future for
  • 27:17for digital health and digital therapeutics.
  • 27:20So we surely know we've seen growing
  • 27:22demand for remote models of of
  • 27:24care and and intervention delivery.
  • 27:26We also unfortunately no across
  • 27:29the globe we've seen a big surge in
  • 27:33behavioral health needs in this country,
  • 27:35in many other parts of the world,
  • 27:37in youth, in adult populations.
  • 27:40You know the statistics are really,
  • 27:42really alarming and and and we
  • 27:44also sadly know that a lot of
  • 27:47people either won't access mental
  • 27:49health care or can't.
  • 27:51And that's not just true in you know,
  • 27:53low and middle income countries.
  • 27:54That's true in rural America.
  • 27:55That's true in in many communities
  • 27:57as you all likely well know.
  • 27:59And so there's this big population
  • 28:02level need and and and you know how can
  • 28:05we scale up capacity to to achieve that.
  • 28:07And we at the same time have been
  • 28:09seeing a pretty striking growth
  • 28:10in the digital health industry.
  • 28:12It it calmed down a bit in the
  • 28:13last year and a half or so,
  • 28:15but it is been growing at at at
  • 28:19great just exponentially really in
  • 28:21terms of start-ups in the space,
  • 28:24in terms of venture investment in the space.
  • 28:26But also as you may know there are
  • 28:29a number of global pharmaceutical
  • 28:31companies that are heavily investing
  • 28:33in digital therapeutics and building
  • 28:36out digital
  • 28:37health formulas, Digital therapeutics in
  • 28:39their portfolio that sort of complement
  • 28:41extend what they traditionally do in
  • 28:43the medication space and sometimes
  • 28:45that these are these are digital
  • 28:47therapeutics that are intended to
  • 28:49have synergistic effects with some of
  • 28:50their medications and or promote you
  • 28:52know more adherence to medications.
  • 28:54But sometimes these are stand alone
  • 28:56tools for a health condition that can be
  • 28:59agnostic to you know if they're with,
  • 29:01if they're used with or without
  • 29:03various medications.
  • 29:04So there's a lot of interesting growth
  • 29:06in the pharma space that you may be
  • 29:08aware of and glad to talk more about that.
  • 29:11And then additionally,
  • 29:11there's A at the same time all
  • 29:13of this is happening,
  • 29:14we're seeing more paths to deployment, right.
  • 29:16So I talked about one which is
  • 29:18this FDA regulatory pathway.
  • 29:19But we also know that in this country,
  • 29:23you know there are employers
  • 29:24that are building out their own
  • 29:27offering to their employees.
  • 29:28There are pharmacy benefit
  • 29:30managers that are doing that.
  • 29:32There are groups like CVS,
  • 29:34Caremark and and others.
  • 29:35So there's a growing array and there's
  • 29:38even over the counter offerings now as
  • 29:41well as this prescription model I mentioned.
  • 29:45And then the final piece to
  • 29:46this of course is payment.
  • 29:48How does this get paid for it?
  • 29:49This is a huge issue and this
  • 29:51has been evolving as well.
  • 29:53I think that many people overestimated
  • 29:55the pace at wish reimbursement
  • 29:57would kick in for these.
  • 29:59So even if you get approved by FDA
  • 30:02and your prescribable software,
  • 30:04it may not get paid for.
  • 30:05So there are definitely some
  • 30:07private payers paying for this.
  • 30:09They're definitely some employers
  • 30:11paying for this.
  • 30:14There are a number of states that have
  • 30:16Medicaid coverage like I mentioned
  • 30:18Massachusetts as an example for this,
  • 30:20but but it's it's just it's a minority
  • 30:23of states that have Medicaid coverage
  • 30:25and there's no national coverage
  • 30:27framework by Medicare at this point.
  • 30:30There is,
  • 30:30though,
  • 30:31a lot of hope that a pending legislation
  • 30:35right now called the Access to
  • 30:38Prescription to Digital Therapeutics Act
  • 30:42that it may get past timelines unknown.
  • 30:45There was hope it was going
  • 30:46to happen last year,
  • 30:46but I know there's a lot of
  • 30:48advocacy efforts for this year.
  • 30:49And if that gets passed,
  • 30:51then we would have national
  • 30:52Medicare coverage of digital
  • 30:54therapeutics in this country.
  • 30:55And and some colleagues feel like
  • 30:58that would then expedite the pace at
  • 31:01which Medicaid would kick in as well.
  • 31:03So there's a lot happening in this country.
  • 31:06There's a lot happening in other countries.
  • 31:07There's entire countries that have
  • 31:09national coverage frameworks,
  • 31:10like Germany and the UK.
  • 31:12Asia has been exploding in this space,
  • 31:14many countries in Asia.
  • 31:16So it's a really interesting time and
  • 31:19there's a lot still to sort of work
  • 31:20out in terms of like what's out there,
  • 31:21because there's there's unfortunately
  • 31:23a lot of hype,
  • 31:24but there's also a lot of
  • 31:25really potent tools.
  • 31:26And I'm very optimistic
  • 31:27that we're going to get to
  • 31:28a landscape where we really have a much
  • 31:30more widespread access to these tools
  • 31:32that people can use in their daily lives.
  • 31:35So what I thought I would highlight
  • 31:37at this point is a a project that we
  • 31:40were able to do that shows you you
  • 31:42know so going beyond the clinical
  • 31:44trials that I highlighted to you,
  • 31:45you know those are promising effects.
  • 31:46But what if you really wanted to scale
  • 31:49up the use of digital tools and really
  • 31:52think about new healthcare delivery
  • 31:54models that centrally leverage digital
  • 31:56health tools as part of the care
  • 31:59model and what would the impact be.
  • 32:01So I I'm going to tell you about an
  • 32:02example of the study we've done in
  • 32:04this space and this was a project
  • 32:06funded by the US National Institute
  • 32:07of Mental Health and it was a project
  • 32:11we did in Latin America and we
  • 32:14started in the country of Columbia.
  • 32:17Columbia, as you may know,
  • 32:18is a part of the world that has a very
  • 32:21high mental health burden and very limited
  • 32:25workforce capacity to tackle that burden.
  • 32:28So you know,
  • 32:29Columbia had generations of armed conflict
  • 32:32and and if you know all the data show that,
  • 32:36you know every community has been touched
  • 32:39by this very high rates of depression,
  • 32:41very high rates of alcohol use,
  • 32:43soft and accompanied by domestic violence
  • 32:45and so very high mental health need.
  • 32:47But if you look at the
  • 32:48mental health workforce,
  • 32:49you have, you know,
  • 32:50a handful of psychiatrists in Bogota
  • 32:52or in some of the more urban settings.
  • 32:54But if you go into rural farming communities,
  • 32:56you have we you have no,
  • 32:59no access to sort of outpatient psychiatry.
  • 33:01There's really only inpatient psychiatric
  • 33:03hospitals sprinkled throughout the country.
  • 33:06So this is just an example of a part
  • 33:07of the world and there are many
  • 33:09other examples we could think of
  • 33:11where you know you have this problem,
  • 33:13right,
  • 33:13you have this big need and you have
  • 33:15limited capacity to meet the needs.
  • 33:16So what what do you do?
  • 33:18So what this project did is to leverage
  • 33:23an integrated suite of digital health
  • 33:26tools to seek to scale across the
  • 33:29country screening and treatment for
  • 33:32mental health conditions in a way
  • 33:35that could help meet this need.
  • 33:37So it was basically a digitally
  • 33:39enhanced model of care that we did
  • 33:41in partnership with Primary Care
  • 33:43Systems across Columbia.
  • 33:45And so Primary care in the country
  • 33:47of Columbia had never talked about
  • 33:49mental health.
  • 33:49It wasn't part of any routine
  • 33:51screening or included in care at
  • 33:54all before this project.
  • 33:55We know that's not true in
  • 33:56other parts of the world,
  • 33:57but it happened to be true there.
  • 34:00But this,
  • 34:01the benefit is that primary care was much
  • 34:03more accessible in many parts of the country,
  • 34:07unlike psychiatric care.
  • 34:08So there was surely some training of
  • 34:10primary care providers in understanding,
  • 34:12you know what,
  • 34:13what is mental health?
  • 34:14Why is mental health important
  • 34:16in the whole as you
  • 34:18think about whole care models
  • 34:20for the patients you serve.
  • 34:22So it's definitely some clinician
  • 34:24training and and support to primary
  • 34:26care providers around embracing this.
  • 34:28But then basically we we integrated
  • 34:30into primary care across the country
  • 34:33and integrated suite of tools that
  • 34:35first included taking clinically
  • 34:38validated digital screeners for mental
  • 34:41health and alcohol use was also part
  • 34:44of this and deliver that entirely in
  • 34:46a digital assessment way that then
  • 34:48directly fed into a digital clinical
  • 34:50decision support tool that providers
  • 34:52could use when interacting with the
  • 34:54patient in front of them and to help
  • 34:57with a diagnosis and then care models.
  • 35:00And then also every single patient
  • 35:03who met criteria for one of the
  • 35:06conditions that we're screening for
  • 35:07was also given a digital therapeutic.
  • 35:09So that was on top of what happened
  • 35:11in primary care.
  • 35:12They had this tool that they could
  • 35:14use every day in their daily lives to
  • 35:17support to provide a mental health care.
  • 35:19And so these are some photos of some
  • 35:21of the tools we used for screening for
  • 35:25the clinical decision support that the
  • 35:28providers used and for the digital
  • 35:30therapeutic that the patients use.
  • 35:32This is a digital therapeutic that we
  • 35:35developed based on a couple of decades
  • 35:37of different NIH funded projects
  • 35:39with different populations where we
  • 35:41took you know sort of core sort of
  • 35:42science of behavior change in the
  • 35:44core active ingredients in helping
  • 35:45people initiate and maintain health
  • 35:47behavior changes and and embedded
  • 35:49it in a transdiagnostic platform.
  • 35:50So we could flexibly provide
  • 35:52therapeutic tools to people depending
  • 35:55on whatever combination of needs and
  • 35:57preferences they have in mental health.
  • 36:00And we have lots and lots of data from this.
  • 36:03It was a big project.
  • 36:04We have wonderful partners across
  • 36:06the whole country work on this not
  • 36:09just research partners but you
  • 36:10know really Ministry of Health and
  • 36:13industry payers and patient advocacy
  • 36:15groups and healthcare leadership
  • 36:17really working on this in order to
  • 36:19be that was really critical in order
  • 36:22to really scale this in the way we
  • 36:23were able to across the country.
  • 36:25So in one,
  • 36:26this is a snapshot of a couple
  • 36:28of years right before COVID.
  • 36:30We saw in that couple years we
  • 36:32went from screening no,
  • 36:33No 10 patients for mental health and
  • 36:35primary care to screening over 22,000 people.
  • 36:39And then of that we had 22% and
  • 36:41positive screens and then 8% diagnosis
  • 36:43of depression or unhealthy alcohol
  • 36:46use in this case.
  • 36:47And so you know this is the those
  • 36:508% would have gone undetected.
  • 36:51You know in the traditional models,
  • 36:53these very simple slide here,
  • 36:54but I just want to give you this was
  • 36:56mostly an implementation science study,
  • 36:57but we we were able to track patient
  • 37:00outcomes for one year every single patient.
  • 37:02We had a whole team tracking patients
  • 37:05for a year and to to to document sort of
  • 37:09their experience clinically for a year.
  • 37:10So these are just some examples of
  • 37:12lots of data that we have including
  • 37:15you know showing a market reduction
  • 37:17in depression symptoms over that year.
  • 37:19And that was true even if you had
  • 37:21pretty severe depression at baseline.
  • 37:24We saw even those,
  • 37:25you know with high versus moderate
  • 37:26versus mild depression at baseline were
  • 37:28able to benefit from this therapeutic
  • 37:30approach and reduce depression symptoms.
  • 37:33Same similar pattern I should
  • 37:36say with problematic alcohol use
  • 37:38over that course for the sample
  • 37:40that had high levels of drinking.
  • 37:42And then even for those who had really
  • 37:45high levels of alcohol use versus moderate
  • 37:48to maybe some lower risk drinking,
  • 37:51again we saw some value for
  • 37:53for all of those folks.
  • 37:55We have a lot of data on how
  • 37:56did this impact the functioning
  • 37:58of the healthcare system,
  • 38:00the clinical workflow,
  • 38:01how people spend their time and
  • 38:04these are just some examples of
  • 38:06some data from those analysis.
  • 38:08So we looked at you know from
  • 38:12administrator point of view,
  • 38:12from provider point of view,
  • 38:14you know what do you think about
  • 38:15adopting this in your setting,
  • 38:17is it is this accessible to do so,
  • 38:19is it appropriate for the context,
  • 38:20is it feasible etcetera.
  • 38:21So what we found is in this two
  • 38:24year window I'm showing here even at
  • 38:25baseline and this was after that we
  • 38:27had trained a lot of the primary care
  • 38:29folks about what we're about to launch.
  • 38:31We had pretty high rates of buy
  • 38:33in and you know on on many of
  • 38:35these dimensions at baseline which
  • 38:37persisted post launch and for two
  • 38:39years post launch for for most of
  • 38:41the data that we've got here there's
  • 38:43some new ones to talk about here.
  • 38:45But in the interest of time generally
  • 38:47we we found that people felt like
  • 38:49it was a value we as part of
  • 38:52the data collection did a pretty
  • 38:55detailed costing assessment.
  • 38:57So you all may know this time driven activity
  • 39:00based costing metric that first came out
  • 39:02of Harvard and it gives you this very,
  • 39:04it's,
  • 39:05it's a very lengthy process to do,
  • 39:06but it's very valuable where you
  • 39:08map the cost of every process
  • 39:10in a clinical workflow.
  • 39:12And then you can see when you introduce
  • 39:14some innovation in a clinical workflow,
  • 39:16how does it impact costs,
  • 39:17what's cost difference.
  • 39:18So the bottom line of this very long
  • 39:21process was that after we implemented
  • 39:23this model in primary care in the
  • 39:25country to screen and treat mental health,
  • 39:28the cost per patient per year was $1.89 U.S.
  • 39:33dollars higher than the what the prior model,
  • 39:36sort of the baseline model before we
  • 39:39before we introduce this new model.
  • 39:40So there's a lot of excitement about
  • 39:42that because of the value that
  • 39:44they saw in doing so and and sort
  • 39:46of the limited cost per patient.
  • 39:48And so you know there's there's a
  • 39:51lot of optimism that that that they
  • 39:54could continue to grow capacity in
  • 39:56the region with this type of tool
  • 39:59and and also grow it to embrace
  • 40:01other areas of health and including
  • 40:02other types of mental health but
  • 40:04other preventative
  • 40:05health promoting interventions and and
  • 40:07other chronic disease management tools.
  • 40:09And again this was the country of
  • 40:11Colombia and now we've expanding our
  • 40:13partnership to Chile and Peru, but.
  • 40:15The nice thing is that this is an
  • 40:17exemplar of a part of the world
  • 40:19where you know we could show value,
  • 40:21maybe we could do so in rural
  • 40:23America or other countries.
  • 40:24And you know it's been exciting to see the
  • 40:27interest in in the region in scaling this up.
  • 40:30Now you know this the funding,
  • 40:32the research funding has ended and now
  • 40:34they are are offering it clinically
  • 40:37and seeking to expand it even more so.
  • 40:40So I'm happy to share papers on that,
  • 40:43but I'm going to shift gears just a
  • 40:45little bit in our remaining time and
  • 40:47I'm watching the clock to make sure we
  • 40:49have enough time here for discussion.
  • 40:50But I want to talk a little bit now
  • 40:54about digital health assessment, right.
  • 40:57So I talked a lot about therapeutics,
  • 40:59but we can learn a lot about people through
  • 41:02digital data capture about their daily lives,
  • 41:04about their, you know,
  • 41:06really granular data even day-to-day about
  • 41:08people's needs in in their real world,
  • 41:10right in their daily lives and and and
  • 41:13provide a lot of insights into people's
  • 41:16clinical status and trajectories.
  • 41:17But then that data,
  • 41:18particularly we can build at
  • 41:19the individual level,
  • 41:21predictive models that help us
  • 41:22understand when someone might benefit,
  • 41:24benefit from an intervention,
  • 41:25can help us then push sort of
  • 41:27digital therapeutics to people when
  • 41:29they might most benefit from them.
  • 41:31You know,
  • 41:32when someone's at risk of relapse
  • 41:33or panic attack or psychotic episode
  • 41:35or whatever it is,
  • 41:36could we in that moment give them some
  • 41:39meaningful therapeutic intervention.
  • 41:41So there's a lot of exciting work
  • 41:43in the space.
  • 41:44Most of it is in mental health,
  • 41:47although that's evolving.
  • 41:48But people are looking at digital biomarkers,
  • 41:52things you can capture in vivo again about,
  • 41:57you know,
  • 41:59sort of in people's environment
  • 42:01and neurodevelopmental context.
  • 42:02That can be done through the very
  • 42:05rich array of sensors you've got
  • 42:07on smartphones and or wearables
  • 42:10like smartwatches.
  • 42:12People are even making smart jewelry
  • 42:14and all kinds of different all kinds
  • 42:17of different ways to capture this rich
  • 42:20information in People's Daily lives.
  • 42:22And and some people call this
  • 42:25digital phenotyping.
  • 42:26And that's just really this very
  • 42:28detailed granular quantification of
  • 42:30these individual level data in the
  • 42:32real world collected through digital devices.
  • 42:34And it could be either passively
  • 42:36collected through sensing like I
  • 42:38mentioned or you can prompt people
  • 42:40to answer brief queries about,
  • 42:42you know, their pain, their craving,
  • 42:44their their mood state, their sleep,
  • 42:46whatever the question is.
  • 42:49And and you can do that through
  • 42:51on digital platforms using these
  • 42:54ecological momentary assessments.
  • 42:56And so the idea is that maybe we
  • 42:58can understand for a given person
  • 43:00what confluence of factors might
  • 43:01predict clinically meaningful events.
  • 43:03And then this sort of some people
  • 43:06call it just in time adaptive
  • 43:08interventions or just in time
  • 43:10delivery of a therapeutic.
  • 43:11There's a lot of exciting
  • 43:12work happening in this space.
  • 43:13I'm going to give you a little
  • 43:15snapshot of first of all what's
  • 43:16happening in substance use disorder
  • 43:18space and then more broadly mental
  • 43:19health and then tell you a bit about
  • 43:21some work we're doing in this space.
  • 43:22So some of the really early work
  • 43:25in looking at these digital
  • 43:28biomarkers in substance use were
  • 43:30heavily with smoking populations.
  • 43:32So, so Shiffman,
  • 43:33you may you may know his work well
  • 43:36we did some early work in this where
  • 43:38where you're tracking people's mood
  • 43:40in a pretty detailed way and they
  • 43:43had a whole line of research here.
  • 43:45It's just one example showing that
  • 43:46lapses to smoking among smokers trying
  • 43:48to quit were associated with increases
  • 43:50in negative mood for many days and
  • 43:52not just hours before a smoking lapse.
  • 43:54So it was this sort of,
  • 43:56you know, sort of this,
  • 43:57a more prolonged negative mood that
  • 43:59seemed to be associated with lapses.
  • 44:01Kenzie Preston who I
  • 44:03understand recently retired,
  • 44:04but there's still a lot of fantastic work
  • 44:07coming out of her former lab at the Nida
  • 44:10Intramural Research Center in this area.
  • 44:12So one of those studies showed that
  • 44:15craving predicted imminent drug use,
  • 44:18but self reported stress was much
  • 44:20less predictive than craving.
  • 44:21So, you know,
  • 44:22they have this whole literature around,
  • 44:24you know,
  • 44:24do these types of data help us
  • 44:27understand more nuance between,
  • 44:28you know,
  • 44:29between different triggers for drug use
  • 44:32including things like stress and craving.
  • 44:34And they also the same lab,
  • 44:37David Epstein's part of that group show that,
  • 44:40you know,
  • 44:41drug triggers,
  • 44:41things that for a given person like
  • 44:43exposure to drug cues or mood changes
  • 44:46increase for hours before cocaine use events.
  • 44:48But we we saw very different
  • 44:49pattern with heroin use events.
  • 44:51So they're also,
  • 44:51you know,
  • 44:52building out a literature suggesting
  • 44:54that this type of data might give
  • 44:56us new insights into different
  • 44:58sort of risk profiles or different
  • 45:00sort of triggers for different
  • 45:02types of substance use in the
  • 45:05personalized intervention space.
  • 45:06Here's some early studies, again,
  • 45:09including again with smoking.
  • 45:10So if you track people smoking risk,
  • 45:13this is what was done in
  • 45:15this particular study.
  • 45:16You know their risk for smoking.
  • 45:18And then and then you trigger a
  • 45:20tailored message responsive to that,
  • 45:22like, you know,
  • 45:22when someone seems like they are at risk,
  • 45:24advise them to a piece of nicotine gum.
  • 45:26Those types of tailored messages were
  • 45:28more engaging and effective than usual care.
  • 45:30Similar study where you give
  • 45:32adaptively tailored advice for
  • 45:33managing withdrawal symptoms
  • 45:34when people are going through
  • 45:36nicotine withdrawal symptoms and
  • 45:38and medication side effects.
  • 45:39We found that that very responsive
  • 45:41in the moment advice was used more
  • 45:43often and was more acceptable among
  • 45:45smokers seeking to quit than usual care.
  • 45:47And then we had a grant from the NIH
  • 45:50Science of Behavior Change Initiative
  • 45:53out of the Office of the Director's
  • 45:55Office and it was on self regulation.
  • 45:57And one piece of that included
  • 46:00developing A momentary self regulation
  • 46:02scale where we can in the moment assess
  • 46:06different aspects of self regulatory
  • 46:08capacity like emotion regulation.
  • 46:10And we found in this study that
  • 46:14digital interventions can impact
  • 46:15momentary self regulation that then
  • 46:17can in turn impact health behavior
  • 46:19across various populations like
  • 46:21people with binge eating disorder,
  • 46:23like heavy smokers.
  • 46:25So very these are just again a
  • 46:27snapshot of of what's evolving.
  • 46:29There's a lot of exciting work
  • 46:30happening in this space now,
  • 46:31including I I I know some folks at Yale
  • 46:33are doing some great work in this space.
  • 46:36We recently finished a study funded
  • 46:39by Nida run on NIDA's clinical trials
  • 46:42network platform that we're part of.
  • 46:44It was in partnership with
  • 46:46Kaiser Permanente and IBM.
  • 46:47And this study was really trying
  • 46:50to understand the utility of
  • 46:52digital data capture with people in
  • 46:55treatment for opioid use disorder.
  • 46:57So we asked outpatients in buprenorphine
  • 46:59treatment for opioid use disorder
  • 47:01if they want to join the study.
  • 47:03And if they did,
  • 47:05we asked them to not only answer questions,
  • 47:09we asked them through these prompts,
  • 47:10these Emas on on a mobile device.
  • 47:12We asked them if we could passively get
  • 47:15data from smartwatches and smartphones.
  • 47:17And we asked them if you have social media,
  • 47:19can we can we take your social media
  • 47:22data and can we look at that data?
  • 47:24And the idea here was to understand,
  • 47:27are some of these data meaningful
  • 47:30in People's Daily lives to help us
  • 47:33understand when people might relapse or
  • 47:35maybe not take their medication today,
  • 47:37for example, right.
  • 47:38We know a lot about you know we
  • 47:40know medication treatment is a
  • 47:42very effective and literally life
  • 47:44saving for opioid use disorder.
  • 47:45And we also know that we
  • 47:48have you know relapses,
  • 47:49we have dropout,
  • 47:50we have non medication adherence and
  • 47:52we have clinical insights into some of
  • 47:55the factors that contribute to that.
  • 47:56But the idea here is if we get
  • 47:58this day-to-day data that's
  • 47:59outside of a clinical setting,
  • 48:01could we get any new insights into
  • 48:03what when someone might be at risk
  • 48:05of these things and where are there,
  • 48:07where is there redundancy
  • 48:08in the data capture, right.
  • 48:10So maybe you know it's just a snapshot
  • 48:12of these data that are really the the
  • 48:14main sort of data to extract that are
  • 48:16meaningful for predicting these things.
  • 48:18That's the big picture of the the
  • 48:20study we we in the passing sense,
  • 48:23passive sensing.
  • 48:24You get all kinds of rich information from
  • 48:27literally not asking people to do anything.
  • 48:29It's just passively collected
  • 48:30in an unobtrusive way.
  • 48:32You can get features that give you
  • 48:34insights into people's activity levels,
  • 48:36into their sleep and quality of sleep,
  • 48:38into their sociability,
  • 48:39into their light exposure.
  • 48:41Lots of different kinds of data you can get.
  • 48:44And then we asked them these brief queries
  • 48:46as you see on the right here about,
  • 48:48you know, their sleep stress,
  • 48:49their pain, craving,
  • 48:52withdrawal symptoms,
  • 48:53etcetera.
  • 48:54And so these are really brief
  • 48:57questions we prompt them to do
  • 48:58on a mobile device.
  • 48:59And then if they had social
  • 49:01media data from Twitter,
  • 49:03Facebook or Instagram,
  • 49:03we could look at those data.
  • 49:05And so we could look at postings,
  • 49:07we could look at sentiment analysis,
  • 49:09we could look at topology of
  • 49:10social networks, the ideas.
  • 49:12Are any of these data really
  • 49:14strong predictors of things like
  • 49:17when someone might relapse?
  • 49:19So this first day was heavily A
  • 49:22feasibility study and we found
  • 49:24that participants in outpatient
  • 49:26treatment for opioid use disorder
  • 49:28carried the phone on 94% of days.
  • 49:30We've been very encouraged by that,
  • 49:31wore the watch 74% of days.
  • 49:34We had a average response rate to our
  • 49:37questions of 70% and we were actually
  • 49:39quite surprised about this last one.
  • 49:41We thought it'd be lower but 88% agreed
  • 49:43to share their social media data and
  • 49:46then we have a lot of data including
  • 49:47a lot of evolving data from this.
  • 49:49But I'm just going to give
  • 49:50you a little flavor of some
  • 49:52of the things we're finding.
  • 49:53This slide is from our EMA data.
  • 49:56So this is again the these questions
  • 49:58that we asked people to answer and
  • 50:0311 predictor that seemed among the
  • 50:06strongest in predicting next day
  • 50:08opioid use is this momentary self
  • 50:10regulation metric that I mentioned
  • 50:12to you that we this the scale that
  • 50:15we developed and validated and
  • 50:16particularly when you track momentary
  • 50:20risk taking about 24 hours prior seems
  • 50:24to be a a pretty strong predictor of
  • 50:28next day non prescribed opioid use.
  • 50:31That's just one example.
  • 50:33Here's another from some of our
  • 50:35passive sensing data and this is
  • 50:37just looking at two channels.
  • 50:37This is looking at heart rate
  • 50:39data from wearables and smart
  • 50:41smartphone conversation detection.
  • 50:42So not what people are saying,
  • 50:44not the content of what they're saying,
  • 50:45but detecting instances of communication.
  • 50:49And again we're seeing some promising
  • 50:53utility of these passive data channels
  • 50:56in predicting next day opioid use.
  • 50:59We also have seen similar pattern in
  • 51:02predicting stress and predicting craving.
  • 51:04Lots of ongoing analysis,
  • 51:05but this is just to give you a flavor.
  • 51:08So why did Nida fund this?
  • 51:09So Nida was interested in thinking about
  • 51:12you know, you know in clinical trials,
  • 51:13let's say we have these great
  • 51:15clinically validated assessments
  • 51:16we do in an episodic way during
  • 51:18the course of clinical trial.
  • 51:19Maybe we're looking at you know the
  • 51:21effects of a novel pharmacotherapy
  • 51:22or or something else.
  • 51:23Could this type of data be meaningful
  • 51:25to add an outcomes measurement and what
  • 51:27type of data from digitally derived data
  • 51:30capture could be meaningful as part
  • 51:31of outcomes measurement in clinical trials.
  • 51:33So that's a big part of it,
  • 51:35that's a big question.
  • 51:37But then, you know,
  • 51:38surely there's a lot of excitement
  • 51:39around if indeed we can get these
  • 51:41models good enough to understand,
  • 51:43you know, when someone might
  • 51:44be at risk and we can really,
  • 51:47you know,
  • 51:47trial the,
  • 51:48the utility of these very responsive in the
  • 51:52moment interventions to help prevent relapse,
  • 51:54for example.
  • 51:55So I think this is an exciting space,
  • 51:58you know,
  • 51:59from the discovery science space
  • 52:00and looking at digital biomarkers
  • 52:01to really translational science,
  • 52:03I think in terms of informing
  • 52:05intervention models,
  • 52:06the the literature is compelling,
  • 52:07but there's a lot of proof of
  • 52:09concept out there for folks who
  • 52:10are working in this space.
  • 52:11But it's growing.
  • 52:12But I think,
  • 52:13you know,
  • 52:13there's a lot of opportunity for
  • 52:15more rigor in this work right now
  • 52:17and more validation of measures.
  • 52:18Lots of people look at different
  • 52:20features that you extract from
  • 52:21sensing and other things.
  • 52:22We don't have a lot of replicability yet,
  • 52:24reproducibility of results
  • 52:25or control studies as of yet.
  • 52:27We have some and it's growing
  • 52:29particularly mental health.
  • 52:30But it's a it's an interesting and
  • 52:33exciting space and I think that
  • 52:35it's promising for mental health,
  • 52:37but also really just thinking
  • 52:39about behavior broadly and it's in
  • 52:41in sort of transcending disease
  • 52:43specific types of behaviors to
  • 52:45really understanding in new ways
  • 52:47the complexity and interrelatedness
  • 52:48of different clinical conditions.
  • 52:50And so in the last couple of minutes
  • 52:52before we jump to discussion,
  • 52:53I just wanted to mention again
  • 52:56our center and this
  • 52:58is a Nida funded center and we,
  • 53:00we are really devoted to bringing
  • 53:03science to the space, right.
  • 53:05Bringing science to the development,
  • 53:07evaluation and implementation of
  • 53:09digital health tools from prevention to
  • 53:12treatment for heavily for substance use.
  • 53:15And mental health is a critical mass of
  • 53:16our group in terms of the work that we do.
  • 53:18But and we do work you know ranging from
  • 53:21precision prevention of cancer to you know,
  • 53:23chronic disease management and diabetes
  • 53:24and and and lots of other areas.
  • 53:26So lots of you know, rigorous science.
  • 53:29We're housed at Dartmouth,
  • 53:30but we work with partners across
  • 53:31the country and internationally.
  • 53:33But it's not just about the science, right.
  • 53:34It's great to be able to do the
  • 53:36rigorous science and publish on
  • 53:37and share it with your colleagues.
  • 53:39But our our goal is really to have
  • 53:41impact and how do we bring the
  • 53:42science to People's Daily lives?
  • 53:44How do we scale things so that the most
  • 53:47how effective and engaging tools are
  • 53:49what people can access and we have a
  • 53:51lot of resources if you're interested
  • 53:53in this work or doing this work.
  • 53:56Some of the current things we're up
  • 53:58to particularly in our recent center
  • 54:00grant renewal is a focus on some of our
  • 54:03transdiagnostic digital therapeutics,
  • 54:04some of the adaptive digital therapeutics
  • 54:07I mentioned some of our faculty are
  • 54:10are are doing some really pioneering
  • 54:12work in the realm of artificial
  • 54:14intelligence as applied to mental health.
  • 54:16We've we've launched several
  • 54:19partnerships with training programs
  • 54:21for underrepresented minority
  • 54:23scholars who are working with us in
  • 54:26digital in training for for becoming
  • 54:28digital health scholars.
  • 54:29And then as I mentioned at the beginning,
  • 54:32you know we are really working on
  • 54:35strategic partnerships with with
  • 54:37lots of different partners in in the
  • 54:40regulatory space and policy and industry
  • 54:42investors and and and not just about
  • 54:45bringing the science to that community,
  • 54:47but really understanding what's happening
  • 54:50in those in that area and what kinds of
  • 54:53questions and data people want, right.
  • 54:54So when payers decide to pay
  • 54:56for a digital health tool,
  • 54:57what do they care about?
  • 54:58You know when the FDA is looking at data,
  • 55:00what do they care about so that
  • 55:02you know our research community
  • 55:03can also be capturing meaningful
  • 55:05data that are meaningful to a lot
  • 55:07of stakeholders in this space.
  • 55:08So to that end we've done several things.
  • 55:10We've launched in the annual Digital Health
  • 55:12Summit with a whole array of partners
  • 55:14with that goal for shared dialogue to it,
  • 55:16with a goal of together increasing pace
  • 55:19of access to the most effective tools.
  • 55:23We launched a Dartmouth Innovation
  • 55:25Accelerator in digital Health in
  • 55:27partnership with our Magnuson Center
  • 55:29for Entrepreneurship at Dartmouth.
  • 55:31Again,
  • 55:31it's about getting things out there
  • 55:33that work and having a path in
  • 55:36the right partners and knowledge
  • 55:37and expertise to bring to that.
  • 55:38So this is a big priority of ours.
  • 55:41And again, happy to chat about it more,
  • 55:43but I want to pause here so we can have
  • 55:46some discussion.
  • 55:47I included my e-mail,
  • 55:49our website for our center.
  • 55:51We have a pretty lively,
  • 55:52particularly Twitter life.
  • 55:53If you all are interested in this,
  • 55:54please follow us.
  • 55:56And then I had to mention we have some
  • 56:00assistant professor level faculty positions
  • 56:02available in our center right now,
  • 56:05so if anyone has any interest
  • 56:07in learning more about that,
  • 56:08please feel free to reach out.
  • 56:10So anyway, thank you for the
  • 56:11opportunity to share this.
  • 56:12I'm going to stop sharing my screen.