ADHD & Digital Medicine (Apps & Games)
Summary
TLDRIn this video, Dr. Russ Barkley discusses the role of digital medicine, particularly the Endeavor video game, in managing ADHD. He highlights the limited evidence base for such apps and games, cautioning against their use as a primary treatment. Barkley critiques the FDA's lower standards for approving digital devices compared to drugs and emphasizes the need for independent research to validate claims of effectiveness. He concludes that while digital medicine shows promise, it is not yet ready for prime time as an evidence-based treatment for ADHD.
Takeaways
- 😀 Digital medicine, including apps and video games like Endeavor, is being used for ADHD management, but the evidence for their effectiveness is limited.
- 📱 Companies have created games and apps for smartphones that claim to improve attention, impulse control, and working memory through practice.
- 💡 Some websites offer a variety of cognitive games for a monthly fee, but they cannot claim to treat diagnosed mental or medical disorders, only to improve cognitive abilities that might be impaired.
- 🚫 The FDA approval for a device like a digital medicine app is not as stringent as for a drug, focusing more on safety than efficacy.
- 🔍 A review found that there are hundreds of apps for ADHD or related cognitive deficits, but most lack research to support their claims.
- 🎮 Endeavor is a video game designed to improve ADHD symptoms, with a version called Endeavor RX that has FDA approval and another called Endeavor OTC.
- 📊 A 2020 study on Endeavor RX showed improvement in lab tests measuring attention but did not demonstrate real-world behavioral changes.
- 🤔 The concept of 'near transfer' refers to improvement in lab measures similar to the game practice, which is not as important as 'far transfer' that extends into real life.
- 🧐 A subsequent trial of Endeavor showed improvement in impairment ratings but lacked a placebo control and did not convincingly demonstrate far transfer.
- 💡 The speaker does not recommend apps or games for ADHD as first-line treatments due to the weak evidence base and suggests buyer beware.
- 👎 The speaker expresses concern about relabeling games as digital therapeutics, as it may be misleading and implies medical treatment without sufficient evidence.
Q & A
What is the main topic of the video by Russ Barkley?
-The main topic is the role of digital medicine, particularly focusing on the Endeavor video game's effectiveness for the management of ADHD.
What has been the trend since the invention of smartphones in relation to mental health apps?
-Since the invention of smartphones, companies have been creating apps, usually games, that individuals can practice on, with the belief that this practice leads to improved attention, impulse control, and working memory.
What is the difference between the claims websites like lumosity.com can make and those they are not allowed to make?
-Websites like lumosity.com are not allowed to claim that they treat mental health disorders or medical disorders. However, they can claim to improve cognitive abilities that might be impaired in various diagnosed mental or medical disorders.
What is the FDA's stance on approving apps for mental health treatment?
-The FDA has a less strict set of standards for approving devices like apps compared to drugs. The main concern is safety, and there must be some evidence of efficacy.
What is the current evidence base for apps and games designed for ADHD?
-The evidence base is extremely limited, with almost no research on most of these apps. The few that have research are often funded by the companies that manufacture and market the apps.
What is the Endeavor RX and how does it differ from Endeavor OTC?
-Endeavor RX is a version of the video game that requires a prescription and is FDA approved. Endeavor OTC, on the other hand, is over-the-counter and does not require a prescription.
What is the primary concern Russ Barkley has about the Endeavor RX study published in 2020?
-The primary concern is that the study relies on a lab test (TOVA) for measuring attention and inhibition, which may not correlate significantly with real-world behavior changes in ADHD symptoms.
What is meant by 'near transfer' and 'far transfer' in the context of digital medicine?
-Near transfer refers to improvements on lab measures similar to what is practiced in the game. Far transfer refers to whether the results of the treatment extend into real-life settings, such as home, school, work, and social functioning.
What does Russ Barkley suggest about the evidence for the Endeavor program's effectiveness in real life?
-Russ Barkley suggests that the evidence for the Endeavor program's effectiveness in real life is thin and not convincing, as the studies lack rigorous examination of far transfer using randomized trials with placebo controls.
What is the general recommendation from Russ Barkley regarding the use of digital medicine apps for ADHD?
-Russ Barkley does not recommend digital medicine apps or games as frontline treatments for ADHD due to the weak evidence base and suggests caution, advising consumers to 'buyer beware' until more independent research is available.
What is the issue with relabeling a game as a digital therapeutic according to Russ Barkley?
-Relabeling a game as a digital therapeutic can be misleading and deceptive to patients, as it implies a medical or digital treatment of the disorder without sufficient evidence to support such claims.
Outlines
😀 Digital Medicine and ADHD Apps
Dr. Russ Barkley discusses the role of digital medicine, particularly focusing on the Endeavor video game designed for ADHD management. He explains that while apps and games claim to improve attention, impulse control, and working memory, their efficacy is often overstated due to lax FDA approval standards for devices compared to drugs. Barkley emphasizes that the evidence base for these apps is weak, with most lacking research support, and he personally does not recommend them due to the limited evidence.
🔍 Scrutinizing the Evidence for Endeavor RX
This section critiques the evidence supporting the Endeavor RX program, a digital medicine application for ADHD. Barkley examines a 2020 study, noting its methodological strengths such as random assignment and double-blind measures but criticizes its reliance on lab tests that poorly correlate with real-world behavior changes. He argues that improvements on the TOVA test, the study's primary outcome, do not necessarily translate to real-life benefits. Barkley also introduces the concepts of near and far transfer, expressing skepticism about the generalizability of the game's effects to everyday life.
🤔 The Limitations of Current ADHD Digital Treatments
Barkley continues his discussion by highlighting the lack of convincing evidence for digital treatments like the Endeavor program. He describes a subsequent trial that showed improvements on an impairment rating scale but lacks a placebo control, casting doubt on the game's effectiveness. Barkley points out common issues in studies funded by manufacturers, such as the absence of independent replications and the failure to demonstrate far transfer to real-life settings, concluding that these games are not ready for prime time as evidence-based treatments.
🛑 A Word of Caution on Digital Medicine for ADHD
In the final paragraph, Barkley advises against considering digital medicine apps like Endeavor as frontline treatments for ADHD due to the thin evidence base. He references a review by Andrew Schuman, which also expresses caution regarding health apps, suggesting they may be recommended as ancillary treatments at best. Barkley personally does not recommend these apps and games for ADHD, advocating for a wait-and-see approach until more rigorous research is conducted. He also addresses his discomfort with the relabeling of games as digital therapeutics, advocating for truth in advertising.
Mindmap
Keywords
💡Digital Medicine
💡ADHD
💡Cognitive Abilities
💡FDA Approval
💡Endeavor RX
💡Evidence-Based Treatment
💡Near Transfer
💡Far Transfer
💡Randomized Controlled Trial
💡Practice Effects
💡Placebo Control
Highlights
Digital medicine, including video games like Endeavor, is being used for ADHD management, aiming to improve attention, impulse control, and working memory.
Smartphone apps and online games claim to enhance cognitive abilities, but cannot advertise as treatments for diagnosed mental health disorders.
FDA approval for digital medicine devices is less stringent than for drugs, focusing more on safety than efficacy.
There are over 300 apps for ADHD or related cognitive deficits, but most lack substantial research support.
Studies on apps like Endeavor often lack real-world evidence, relying on lab tests that may not correlate with actual behavior changes.
Endeavor RX, an FDA-approved version for children, and Endeavor OTC are examples of digital medicine, but their efficacy is still under scrutiny.
A 2020 study on Endeavor RX showed improvement in lab tests but did not demonstrate real-world behavioral changes.
The importance of distinguishing between 'near transfer' in lab settings and 'far transfer' to real-life situations is highlighted.
A subsequent trial of Endeavor in 2021 showed some improvement in impairment ratings but lacked a placebo control for comparison.
Practice effects on rating scales can lead to improvements even without intervention, questioning the validity of some study results.
The need for independent replications of studies on digital medicine apps and games is emphasized for better reliability.
Dr. Barkley does not recommend apps or games as frontline treatments for ADHD due to the weak evidence base.
A review by Andrew Schuman on mental health apps suggests caution, recommending apps only as ancillary treatments with thin evidence.
The relabeling of games as 'digital therapeutics' can be misleading and is a point of contention for some professionals.
More research is needed on digital medicine apps to establish their efficacy and role in ADHD treatment.
Consumers are advised to be cautious, as many companies capitalize on the lack of consumer knowledge about FDA approval standards for devices.
Transcripts
hey friends Russ Barkley here welcome
back in this short video I want to talk
about the role of digital medicine
generally and specifically the Endeavor
video game for management of
ADHD ever since the invention of
smartphones we have seen companies move
into the space where they create uh apps
usually games where individuals can
practice on the game and It is believed
that this practice leads to improved
attention improved impulse control uh
and improved working memory now depends
on what app you have as to which or all
three of those might be included in the
app uh besides these apps that can be
used on Smart devices you can also go
out on the internet to several websites
that allow you to for a monthly fee
practice on a variety of these games now
now the thing about these websites such
as lumosity.com just to name one uh is
that they are not allowed to make claims
that they treat mental health disorders
that is diagnosed disorders or even
medical disorders specifically but they
can claim to improve cognitive abilities
that might be impaired in various
diagnosed mental or medical disorders uh
and it's kind of the same with these
apps although they're not as well
regulated uh some of the companies that
make these apps have gone to the FDA to
get their approval for their device
understand however that the guidelines
for that FDA approval for a device are
not as strict or as high a set of
standards as if you were asking the FDA
to approve to approve uh a drug uh and I
I think that's important because
oftentimes companies trade on the fact
that consumers don't know about that
difference and when they see that uh a
game or an app has FDA approval uh they
think that it has met a very high bar
for standards of evidence for
Effectiveness and safety uh and in fact
that's not the case the bar is pretty
low there has to be some evidence of
some efficacy but it's mainly issues of
safety that the f da is most concerned
about here with a device that is so uh
we've got all these apps out there at
last count one review I looked at a
while ago counted 300 apps for either
ADHD specifically or for ADHD related
cognitive deficits more generally such
as working memory for instance um and
the the problem is as this review found
is that there's almost no research on
most of the these apps uh and the few
that have research might have a paper or
two often funded by the company that's
manufacturing and um marketing the app
uh and so what's a consumer to to do
with these things right now the evidence
base is so weak personally I don't
recommend any of these apps or games for
ADHD or even any of the websites just
because of the extremely limited
evidence base for them out there uh I'm
going to uh use the Endeavor gaming
program as an example of digital
medicine uh not because they're any
better or any worse than any others but
because they're the one that was in my
newsfeed twice this week when I was
looking at the trade media uh Endeavor
is a video game played on a smart device
that uh is supposedly improve symptoms
of inattention
impulsivity uh other related symptoms of
ADHD and there is a version for children
called Endeavor RX uh that's the one
that has the FDA approval and then there
is an overthe counter called Endeavor
OTC that doesn't require a prescription
uh but both of these require a fee uh
and in the case of endeavor RX uh also a
prescription
in order to access the game uh so very
clever there because it makes it sound
like this is kind of a drug it's digital
medicine it's FDA approved and therefore
it must meet a high bar of evidence and
safety and don't be misled by that
that's that's not the case it's just a
device and devices uh can pass through
FDA approval much much more easily than
drugs as I've already said so uh
Endeavor is this video game that you
play That's supposed to improve these
symptoms as I've mentioned uh now what
is the evidence for this uh obviously
these trade articles uh interview
company representatives and they claim
that it does have evidence for
improving uh in atttention uh improving
impairment uh and other symptoms related
to ADHD but but is that really the case
uh let's take a closer look one of the
first papers
on the Endeavor RX program uh which is
manufactured by the company uh achil uh
is this article that appeared in 2020
that was a uh randomized trial of their
software for children ages 8 to 12 uh
with ADH so uh it's a reasonably good
study it involve random assignments uh
the improvements uh or that is the
measures were collected in a double
blind fashion the groups went through
treatment in parallel fashion uh and so
it's a good controlled trial with
pediatric patients uh and all of these
patients had to have diagnosed ADHD
confirmed with clinical
diagnosis uh now what's what's the
problem with this paper which claimed to
have found Improvement uh in lab test
measuring attention uh and inhibition
the lab test they used was the Tova the
tested variables of attention uh and
they assessed individuals at several
time points across the trial the primary
outcome measure for the trial uh was
changes in the Tova score uh and in this
case the attention performance score
from pre to post uh intervention and
then they also looked at safety side
effects and so on but um so you know in
in terms of the rigor of the trial is
pretty good however the problem here is
that it's using a lab test of ADHD and
you've heard me say in other videos
particularly my one on the role of
neuropsychological testing for
diagnosing ADHD that lab measures are
not very good for diagnosing
ADHD or for monitoring change in
treatment that reflect changes in real
world Behavior now why is that because
these tests don't correlate
significantly with rating scales of
realworld ADHD symptoms or of executive
functioning so we don't know what
they're predicting with regard to what's
changing out there in real life so you
could get a change on a lab test that
would not necessarily be reflected in
any any changes out there in real life
as assessed by parents teachers or in
the case of adults uh self- ratings uh
and so it to me uh it kind of
obscures the issue when all you give is
a lab test so yes they did find
Improvement um as assessed on the Tova
measure of attention however if you look
into the study results you look deeply
into the methods they did collect
ratings of ADHD symptoms uh and other
aspects of daily life functioning and if
you look at the results they didn't find
anything what they found was
improvements on the TOA and since that
was their primary measure they get to
claim that this was a successful trial
but what we want to know as clinicians
and as clients is did it change their
life uh and at this point the study does
not
suggest real world changes now here's
where we need to talk about something
researchers talk about when you design a
game or an intervention like this you
can look at what is called near transfer
that is do you improve on measures in
the lab that are similar to what you're
practicing in the game in this sense the
Endeavor RX provant shows some near
trans
but that's not real important as I've
said because measures in the lab often
don't correlate with real life so the
next thing we want to know is far
transfer does the results of the
treatment program extend into real life
natural settings home school work social
functioning and so on and we didn't see
that in this trial so that's very
typical
of studies of these apps for instance
cogmed was a very popular app over a
decade ago for training working memory
in people with ADHD uh it's even more
popular in Europe than it was in the us
at the time but a number of studies were
done on
cogmed that found that all you got you
got better at the game you got better at
measures in the lab similar to the game
but there was no convincing evidence
that it extended into real life
situations so I don't hear an awful lot
about cogmet anymore uh at least here in
the US uh but I do hear more about this
particular digital medicine application
and that's the Endeavor program So based
on that one trial uh I for one would say
well it seems to have some promise at
least on lab measures but we need to see
that there's benefits in real life and
we didn't see it there uh subsequently
another trial was published in the
journal npj digital medicine uh that
involved this game uh and in this case
it was given to kids who were on
medication and kids who were not on
medication and in this time they did use
a impairment rating scale and they
looked at before treatment and four
weeks into treatment
uh in playing this game and what they
found was that there was Improvement in
the impairment ratings over that time in
both the treated the stimulant treated
and the non-treated group um so that's
interesting but again to a scientist
like myself it it's kind of a a so what
finding because we know that if all you
do is measure something with a rating
scale or a test
before treatment and after the treatment
you often see
Improvement and it may have nothing to
do with the treatment it may have to do
with contact with professionals it may
have to do with increased attention from
professionals or in this case parents
that are encouraging their children to
play the game uh it may have to do with
practice effects on these rating scales
we've known for decades that if you give
a rating scale twice to anybody even if
you don't do anything the second score
is often significantly lower than the
initial score so there's practice
effects on the rating scales and so for
that reason researchers like studies
like this to give the scale once before
treatment give it again just before
treatment and then after treatment and
then you've gotten rid of the majority
of practice effects though not entirely
there continue to be improvements on
rating scales with repeated applications
of the scale even when there's no
intervention but the largest jump occurs
between time one and time two now the
second thing you need to do in a study
like this is you need to have an active
Placebo condition which this second
study didn't have it's just comparing
the patients before and after uh it it
does show that the game add something to
people who are on medication but again
that's not convincing because there's
no comparison Placebo
intervention where we might have found
the same effect with a placebo game
being given to these individuals that
doesn't Target attention and uh other
aspects of of ADHD so again there's a
couple trials out there they're kind of
interesting to a researcher they're not
real rigorous when it comes to looking
for far transfer using randomized trials
with Placebo
controls and both ratings and if you
want lab measures as well but the
naturalistic measures are much more
important now I know that's gotten into
the weeds a little more than you like uh
but it does exemplify what's happening
in the space called digital medicine
where games and apps are being used and
are being advertised for use in
improving ad PhD in patients and what
what do we have uh most apps and games
have no evidence whatsoever other than
the claims of the manufacturer even
where there are studies as in the case
of the Endeavor program by achil these
studies were funded by the manufacturer
the marketing company for the achil app
uh and so one has to at least say CAU
iously buyer beware until we get
independent
replications of these apps games and
specifically the Endeavor program these
are not something that I would recommend
as Frontline first line treatments for
ADHD uh again as I said about neuro
feedback earlier this week uh if you've
tried the other things and you're still
not satisfied with the other treatments
that are evidence-based and you've got
Expendable income and you want to play a
game um okay fine nobody's going to talk
you out of doing that but if you're
claiming that these games and apps are
equivalent to the science-based
interventions for ADHD uh then I'm sorry
there's just no evidence-base to support
that kind of definitive conclusion about
these games or apps uh now there was
recently in a mental health newsletter a
nice review by Andrew Schuman on mental
health health apps and should Mental
Health Providers recommend them and they
also talk here about the Endeavor app uh
and the conclusion of this article uh is
uh
that the first of all we have to be
assured that the patient downloads and
uses the app routinely second it's
helpful if benefits are seen right away
because it encourages people to continue
with the game but beyond that as he
points out the evidence base for these
apps uh is is pretty thin so uh you can
recommend them if you wish as ancillary
treatments if I can even call them
treatments but I certainly don't
recommend them to patients myself uh or
uh even as you know fun things to play
that might have some benefits at this
point now just as it aside I have a lot
of trouble with
relabeling a game as a digital
therapeutic it is just a game I think
the relabeling uh is a bit uh confusing
to patients a bit deceptive it implies
that there's something about this game
uh that leads to some kind of medical or
or digital treatment of the of the
disorder uh so so watch out for that
again it's just a personal preference of
mine I I you know to me it should be
truth and advertising do games help
people with ADHD and and don't relabel
this as a digital medicine uh which some
of these uh promoters have so uh so
there you have it right now I think this
is not ready for prime time it's not an
evidence-based treatment the evidence
for most apps is wanting the evidence
for this particular game or app is
pretty thin as well and to a scientist
like me not especially convincing so
time will tell we need a lot more
research on these apps as Schuman talks
about in his uh article editorial if you
will here in contemporary Pediatrics so
that's the status of the field everybody
as always buy or beware thanks for
joining me don't forget to subscribe if
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others uh otherwise I hope you found
this video informative thanks again
everybody see you next time be well
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