The Key to a Sustainable Mental Healthcare Model

When a patient seeks care for an illness, they need to trust that the treatment offered to them has been proven safe and effective through rigorous scientific testing. Seems obvious, yes? The field of medicine relies upon the trust between providers, pharmaceutical companies, and patients, whether that treatment is delivered through an in-person appointment, a virtual chat, a medication, or a mobile app-based therapy. The mode can vary; the quality of care must not.

I find it disturbing, then, to see some mental health apps being released without the same rigor of testing as other non-digitally based treatments. Apps may be “evidence-informed,” which does not rise to the “evidence-based” standards of medical therapeutics, which rely on both randomized clinical trials and real-world data to prove their efficacy and clinical effectiveness.

Imagine releasing a cancer drug or a blood pressure medication to the public before obtaining proof that it works. We’d never allow it. Yet such solutions, many classified as health and wellness apps, are regularly suggested to people suffering from depression, anxiety, insomnia, and more—vulnerable people struggling with mental health and seeking care. We must provide therapies they can trust.

On the other hand, digital therapeutics, which are often classified as software as a medical device, deliver evidence-based, clinically evaluated software to manage and prevent a broad spectrum of health challenges and meet the high standards that the field of medicine requires for other therapies. Clinicians, patients, and insurers need to distinguish which digital offerings meet these thresholds and effectively treat mental health. The stakes are too high, the need is too immediate, and mental health problems deserve treatments that actually work.

Dual Mental Health Crises

We’re experiencing two simultaneous mental health crises. First, we have an exploding number of people suffering from mental health challenges. In the United States, the percentage of high schoolers who reported feeling “persistent feelings of sadness or hopelessness” rose from 26 percent to 44 percent between 2009 and 2021. Nearly one-third of adults will experience anxiety disorders during their lifetimes. About four in ten adults have reported symptoms of depression or anxiety, up from one in ten in 2019.

Second, we have far too few providers to offer sufficient care. To meet the need, the United States alone would need nearly 4.5 million additional qualified mental health professionals, according to a 2020 report by the Substance Abuse and Mental Health Services Administration. Currently, we have approximately 100,000 licensed therapists in the United States.

In-person therapy is hugely important, but it is not a scalable solution. It would take many years and a massive undertaking to train enough providers to help all the patients who need them—patients who can’t wait. What we’ve used as a scalable intervention to bridge what is in fact a cognitive behavioral therapy gap has been pharmacotherapy—that is, medication. Nearly one in four Americans take a prescription drug to treat mental illness.

But often, medication is not meant to be a long-term solution, and some patients prefer a non-pharmaceutical treatment. Mental healthcare needs another scalable option to present to patients—one that has been as tested and is as trusted as in-person therapy and prescription medications.

The Emerging Field of Digital Therapeutics

The reason behind much of the confusion between wellness apps and digital therapeutics lies in a logical fallacy. Some apps try to give the impression that they’re effective simply because they incorporate CBT. CBT has been proven to help patients modify behavior and build life skills to cope with conditions such as anxiety and insomnia, and it has direct effects on thoughts, behaviors, biology, and physiology.

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Because CBT has been proven effective, they claim their app must be effective as well. Not true. Each app needs to prove the efficacy of its interface and its specific delivery of CBT. As I wrote for Health Affairs, requiring gold-standard evidence enables providers and patients to distinguish between a proven digital therapeutic and a wellness app.

It’s clear why the field of digital therapeutics has become a major industry, capturing not only the attention of clinicians, patients, and insurers but also investors—all of whom recognize that another scalable, evidence-based treatment for mental health is desperately needed. Globally, the digital therapeutics market was $3.5 billion in 2020 and is expected to grow to $23.5 billion by 2030.

Due to this significant opportunity, it is tempting for some people to apply a familiar business model to digital therapeutics. When creating software that improves business productivity or provides entertainment, one can launch a product, sell it, gather analytics, and iterate as they go.

What works for a cell phone or laptop, however, cannot apply to a medical treatment. Before a patient even begins a digital therapeutic, they must trust the data has already proven it to be effective. We can’t allow people to be uncertain whether they’re receiving an evidence-based therapy or, in effect, a placebo. We cannot lower standards because a therapy is digitally based, nor can we lower standards for an illness that affects mental, rather than physical, health.

Bridging the Gap in Mental Healthcare: Evidence-Based Digital Therapeutics

Digital therapeutics, when held to high standards, have the power to narrow the gap in care that’s plaguing mental health—to offer another way to scale care to treat the millions of people who need it. This is a solution rooted in evidence as much as hope. We already have randomized clinical trials and real-world data that show which digital therapeutics are effective in treating mental illness. Let’s start there.

We know that holding digital therapeutics to an evidence-based standard is possible because it’s already been done. To release apps to the public as if they were proven therapeutics when they haven’t reached that standard—or don’t aspire to—is to create a moral and professional liability.

Some clinicians, insurers, and patients remain cautious of the new model, understandably. If we can raise the bar on testing so that all digital therapeutics rise to the evidence-based standards of other medical therapies, however, we can increase this confidence, build trust, and create a scalable model of mental healthcare that can revolutionize the industry and offer much-needed care. The key to creating a sustainable mental health model is to implement evidence-based solutions, and digital therapeutics are in a prime position to do just that. The millions of people suffering from mental health problems need and deserve protection against anything less.