The “Standard of Care” in Mental Health is Failing Us, Digital Therapeutics Show a Better Way Forward

The statistics are clear – mental illness is the public health crisis of our era. Almost 1 in 10 American adults suffered from a depressive disorder in the past year, and almost double that number suffered from an anxiety disorder. Prevalence is even greater among youth, and rates are only increasing, as are other mental illnesses like trauma-related disorders, addiction, and suicidality. Yet, treatments remain woefully out of reach or inadequate. For example, only half of those diagnosed with a mental illness seek treatment due to barriers ranging from stigma to cost to accessibility; and of those who do receive treatment, only half see meaningful benefit (1,2,3). Worse yet, frontline treatments like SSRI or benzodiazepine pharmacotherapy carry risks of serious side effects and, in the case of benzodiazepines, abuse and overdose.

This is the standard of care in America today. However, many are now working to advance new, app-based treatments called “digital therapeutics” that show enormous potential to improve this standard with considerably lower risks. Last month, the House Energy and Commerce subcommittee on Health discussed with CMS the pressing need to ensure reimbursement and coverage for this emerging class of treatment. Over the last half decade, many stakeholders across the continuum have seen the promise in DTx innovation and pushed forward considerable advancements in a healthcare system that is not known for its speed and efficiency. However, there’s still a long way to go. To truly transform the standard of care, we should first understand how we got here. 

The Medical Disease Model

In 2006, a large clinical trial called STAR*D had an enormous impact on the field of mental health treatment. It played a major part in convincing a generation of patients and practitioners that major depression – and by proxy other mental health problems – were purely medical diseases described as “chemical imbalances” of the brain. 

At the time, STAR*D was the largest long-term study ever conducted to assess the efficacy of SSRIs in treating patients diagnosed with major depressive disorder. Researchers found a startlingly high remission rate of 67% among those receiving SSRIs. Based on these impressive results, prescription rates skyrocketed and remained high over the next 17 years, while prescribing practices radically morphed to prioritize repeat usage of SSRIs, as opposed to the single regimen documented to show benefit. 

But a recent re-analysis of this famous trial dealt a death blow to the medical disease model of depression by revealing a shocking truth: The original estimate that 67% of patients on antidepressants experienced remission was inaccurate; in reality, only 35% got better. This new evidence of antidepressants’ lesser impact, coupled with psychiatry’s recent realization that depression may not be the result of an underlying biological imbalance after all, provides compelling evidence for non-pharmaceutical interventions as a front line approach for depression.

One common category of non-pharmaceutical intervention, cognitive behavioral therapy (CBT), has shown promise. However, most forms of CBT typically require clinician involvement, and we are in the midst of an unprecedented shortage of mental health practitioners. Despite an excellent evidence base, and fulsome acceptance of these therapies as the best psychological treatments available, there remain pervasive and systemic barriers to CBT’s positive impact. It is time consuming, expensive, and difficult to access. It also remains stigmatizing, as seeking therapy is often framed as a means to eradicate a disease state as opposed to a means through which patients can build positive mental habits. CBT is plagued by the difficulties inherent in any behavior change endeavor; you can talk about change in the therapy room all day long, and it doesn’t necessarily translate to sustained change in everyday life. Moreover, some key factors influencing mental health, like biases towards negative information, are not directly targeted by CBT or pharmaceutical interventions.

Don’t misunderstand – for many patients, both pharmaceuticals and CBT have been literally life-saving, and 100 years of research has greatly advanced our understanding and acceptance of mental health. Unfortunately, the barriers associated with these treatments means that the majority of the population cannot access them, and a subset of those who do, do not benefit. Even our current “best in class” treatment approaches are not enough.

Changing the Game in Mental Healthcare

With the medical disease model on one hand, with its overprescribed and risky pharmaceuticals plus endemic barriers to accessing and benefitting from clinician-administered CBT, mental healthcare in America is primed for limited impact on mental illness and continued crisis.

That’s why we at Arcade, as well as other digital therapeutics developers, the Digital Therapeutics Alliance, the American Psychological Association, the American Medical Association, legislators, regulators and many other constituencies have committed to a crucial and long-overdue paradigm shift: establishing evidentiary standards, clearance processes, and reimbursement frameworks for DTx. 

However, all DTx companies are clear on one point: we are not the same. Depending on the technology, the mechanism of action, and the therapeutic area, DTx treatments can range from AI chatbots, to immersive VR, to more content-oriented education. And, more often than not, these interventions have some degree of gamification to encourage behavior change, whether leveling up, getting streaks or achieving a high score. 

But at Arcade, we don’t just stop at gamification. Gaming is at the heart of our vision. Luckily, for us this means more science, not less. That’s because our core intervention approach, a form of cognitive training called attention bias modification (ABM), marries the best of neuroscience, gaming, psychology, UX/UI, cognitive science, and behavioral psychology. 

ABM is embedded in our game-based pipeline of products targeting anxiety disorders, depression, and addiction. Our technology works by reducing unconscious mindsets and habits of thinking called attention biases (AB). Anxiety-related AB, for example, is selective and exaggerated attention towards threat, which has been strongly linked to neural circuitry and behavior related to fight-flight, anxiety, and worry. AB occurs automatically and unconsciously, acting as an information filter that selects threat-relevant information at the expense of noticing positive outcomes or safety. If rigid and sustained over time, this bias towards threat can cause a cascade of cognitive, affective, and biological changes that give rise to and maintain symptoms of anxiety. ABM disrupts AB towards threat and increases cognitive flexibility, thus driving enduring reductions in anxiety symptoms. 

As tested in research contexts, ABM is effective as an early intervention, stand-alone treatment, and synergistic treatment with complementary approaches like CBT and medication, which aren’t optimized to target AB. ABM has been particularly successful in the treatment of social anxiety disorder (SAD), showing reductions of clinical symptoms comparable to treatment effect sizes of traditional cognitive behavioral therapy (CBT), as well as other anxiety disorders, major depression, addiction, and trauma-related disorders.

Arcade’s ABM-based therapies are brief, computer-based, and easy to use. By ameliorating unconscious habits of attention that other interventions fail to target, they have the downstream effect of reducing clinical symptoms. We’ve taken the crucial extra step of embedding ABM into a game-based format, boosting engagement and reducing the stigma of mental health therapy through the power of gaming. The backbone of our approach: intervene early with science-first, low-barrier, and engaging games that provide therapeutic benefit alone while also synergistically improving efficacy of other therapies.

We have made steady progress toward our goals. First, our Chief Science Officer Dr. Tracy Dennis-Tiwary generated a decade of research validating our treatments through a combination of biometrics like heart rate variability, cortisol levels, eye tracking, MRI, and EEG, alongside validated clinical outcomes integral to the FDA approvals of SSRIs and benzodiazepines. Following a meeting with the FDA to discuss study design, we completed a successful placebo-controlled pilot trial in which we showed that our therapeutic game, StarStarter Rx (ABM-01), successfully reduced social anxiety symptoms compared to a nearly identical “sugarpill” version of the game. By then presenting these findings to the FDA, we further gained insights and confidence into what it’s going to take to obtain FDA clearance through our upcoming pivotal trial. This clearance is important to us at Arcade because it clearly signals to patients that they are receiving the highest quality of treatment. Finally, our second product ABM-02 for major depressive disorder recently became the first digital therapeutic to receive a $3.8M federal grant from the NIMH for a 600-person sample confirmatory efficacy study to be conducted by UT Austin. ABM-01 and ABM-02 would be the first FDA-cleared digital therapeutics for anxiety and major depressive disorders respectively, poising us to address some of the largest patient populations of any digital therapeutics to date.

As we look toward the future, our mission is to partner with tech-forward health systems, universities and insurers to deploy our game-based treatments in real world settings and continue the never-ending journey of evidence generation, while also improving outcomes for patients in desperate need. If you are interested in partnering with us, please reach out to nayan@arcadetherapeutics.com for more information.