America’s mental health crisis is showing no signs of slowing down, underscoring the urgent need for accessible treatments. While innovative technologies are employed in mental healthcare, maintaining patient engagement can be challenging. But what if mental health treatments could be provided where patients already are engaged?
This is the promise of a new biofeedback software development kit created by DeepWell DTx. The digital therapeutics kit, which received approval from the Food and Drug Administration in early September, can transform new and existing media products, such as video games and movies, into digital mental health therapeutics. As a result, access to mental health support could be significantly expanded.
Expanding access is critical as more than one in five American adults live with a mental illness, according to the CDC. In fact, Americans’ mental health concerns have grown since the height of the COVID-19 pandemic, with a 2024 survey showing that 65% of 2,000 U.S. adults acknowledged concerns about their own mental health or that of a family member or friend, up 15 percentage points from 2020.
Amid the growing need for mental healthcare services, the country is facing a mental health provider shortage. Advanced technologies are increasingly employed to manage this imbalance between the demand for and supply of mental healthcare.
Research has shown that digital health applications targeting depression and anxiety symptoms can support patients who are having trouble securing initial mental healthcare appointments. Digital therapeutics, which are evidence-based, clinically evaluated software and devices, can also deliver mental health treatments in lieu of in-person care.
The new FDA clearance adds another tool to the digital care toolbox to combat this issue.
“While people have known that there’s the potential for digital media, gaming and things like that to really do significant therapeutic things, I think what we see now is, with this FDA approval, this is really going to change how we think about digital media as a therapeutic,” said Russell Lonser, M.D., professor and chair of the department of neurological surgery at the Ohio State University College of Medicine, in an interview.
In layman’s terms, the software development kit allows technology developers to add DeepWell’s biofeedback mechanism to their media products. The biofeedback mechanism is a vagal nerve stimulator, explained Ryan Douglas, co-founder and chairman of DeepWell DTx.
It turns out when you’re using media, you are very, very bioavailable to learn new behaviors and not just on the conscious level, but on a subconscious level. Ryan DouglasCo-founder and chairman, DeepWell DTx
Typically, vagus nerve stimulation involves using mild pulses of electrical energy to stimulate the vagus nerve in the brain through a device similar to a pacemaker.
“But we cleared with the FDA [an approach] where we get you to make patterns of sound, and that pattern of sound allows us to detect [your respiration rate], and then [we] use the biofeedback mechanism to control your respiration rate,” Douglas said.
For example, the biofeedback mechanism could operate through music in a video game or movie. The music is designed to provide rhythmic opportunities to breathe, hum or sing along with it, allowing the music to have a therapeutic effect on their stress levels. This results in a learned action that a person could use to reduce their stress even when they are not using the media product.
“It turns out when you’re using media, you are very, very bioavailable to learn new behaviors and not just on the conscious level, but on a subconscious level,” Douglas noted. “So, we can start getting you more and more attuned or programmed in a way that when you are induced with something very stressful, you have a pre-learned mechanism of action.”
The media creates a positive association with learning the action, allowing people to create new neural pathways, he added.
According to Lonser, the data generated by the biofeedback mechanism has the potential to further evidence-based treatment of mental health disorders. Health metrics like respiration rates can be collected to give researchers a more in-depth understanding of mental health conditions and whether a certain treatment is working. This would enable mental healthcare professionals to fine-tune treatments in real time.
“We can envision, in the future, around mental health and anxiety, depression, these types of things, you could see the ability to monitor feedback in patients as they evolve and get therapy,” said Lonser. “You could also monitor the effectiveness of therapy.”
Adding the biofeedback mechanism to engaging media can also solve a significant challenge in mental healthcare: patient engagement.
“A lot of people enjoy and engage in video games, as everyone knows,” Lonser said. “Imagine if you have a therapeutic that someone enjoys … It’d be like having a pill that everybody enjoys taking all the time.”
Why the FDA clearance is significant
Though the use of digital therapeutics is rising, many companies have been unable to survive the challenges of the U.S. healthcare system. Though by no means a panacea, FDA approval has proved critical in helping digital therapeutics developers manage the complexities of the industry.
According to Douglas, one reason digital therapeutics products fail is that keeping the media engaging requires developers to enhance or create new media; this, in turn, requires new FDA approvals, which take up time, money and resources.
The FDA approval of the biofeedback software development kit could solve this issue, allowing developers to add an approved mechanism to their media to turn it into a mental health treatment, Douglas said. Since the biofeedback mechanism already has FDA approval, it acts as a “software kernel” that can be included in new or enhanced media.
“We are now providing an opportunity to get access to that clearance in a much more expedited fashion,” Douglas said.
Supporting faster FDA approvals and allowing access to mental health treatment within already popular media could significantly expand the reach of mental healthcare, which is much-needed amid the mental health crisis in America.
According to Lonser, the FDA approval of the biofeedback kit indicates a vital turning point in the acceptability of including therapeutic features in digital media.
“These games are very engaging … So, I think that this is kind of a watershed moment moving forward with this FDA clearance, where I think now it’s going to be even more widely accepted that digital media, immersive environments and biofeedback that’s coming from that digital media, [can have a therapeutic effect],” he said.
This watershed moment also follows a federal proposal to create a reimbursement pathway for mental health-related digital therapeutics. In its Physician Fee Schedule (PFS) proposed rule released earlier this year, CMS proposed various new codes for digital mental health treatment devices used in conjunction with ongoing behavioral health treatment. Experts noted that this proposal signifies a significant shift in how traditional payers view digital therapeutics’ staying power in the industry.
A lot of people enjoy and engage in video games, as everyone knows. Imagine if you have a therapeutic that someone enjoys… It’d be like having a pill that everybody enjoys taking all the time. Russell Lonser, M.D.Professor and chair, Department of neurological surgery, Ohio State University College of Medicine
“I think in a very short period of time, we’ll be talking about what a sea change this is for therapeutics and mental health, and I think this will extend beyond that,” Lonser said. “I think [digital therapeutics] can [be used to treat] other neurologic disorders that include cognitive disorders, neurodegenerative diseases, as well as potentially movement disorders, like Parkinson’s disease — a whole host of things.”
Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.
