As the pandemic shatters Americans' mental health, the FDA, psychiatrists, and developers are bettin

• The COVID-19 pandemic has exacerbated the US mental-health crisis, with apps like Calm and Headspace booming as people try to cope.
• Now, a new cohort of apps are working to directly treat mental illness, rather than just help people get by.
• Three such companies told Business Insider their programs can drive similar results as medication, and said they believe in-person therapy is outdated.
• The Food and Drug Administration has in recent months moved to help these mental-health apps become more available.
• Experts at the FDA, National Institute of Mental Health, and American Psychiatric Association told Business Insider that evidence indicates the apps work, and that regulators are frantically playing catch up.
• Visit Business Insider's homepage for more stories.

The coronavirus pandemic has precipitated a universal mental-health crisis.

Symptoms of anxiety and depression are rising across age groups, with redundancies, isolation, and health anxiety manifesting despair and hopelessness.

US adults have shown three times as many symptoms of depression during the pandemic than the same period in 2019, researchers at Boston University found in September.

"There's been an exacerbation of existing symptoms," Dr. Adam Haim, chief of treatment and preventive intervention at the National Institute of Mental Health, told Business Insider. "Then, you have individuals exhibiting new symptoms."

Healthcare providers have also struggled to keep pace with the soaring rates of mental illness for years, with therapists oversubscribed and new antidepressants showing little improvement on their predecessors.

Many of the mental-health apps to help people cope, like Calm and Headspace, have seen staggering usage in the pandemic. Mental-health startups are also securing record levels of funding.

Now, a select group of apps are seeking not just to help people get by, but to take the treatments normally confined to psychiatric clinics and put them in a person's hand.

"There's a broader acceleration in digital health," Nate Beyor, a digital-health expert at the Boston Consulting Group, told Business Insider. "The slope has changed, it's become more aggressive."

The swift rise of these apps has prompted the question: Can they be as effective as drugs at treating mental illness?

'Be your own therapist'

These apps vary in price, and can cost as much as a course of in-person therapy or medication. But it is clear that they are more ubiquitous, accessible, and future-proof.

Click Therapeutics, Pear Therapeutics, and Orexo are three companies currently leading the field in the digital-health space. All have developed software to treat mental illness with cognitive behavioral therapy (CBT).

Broadly, CBT helps people understand why they think and act the way they do, and helps them manage and change those habits through reflexive tasks.

Pear is behind Somryst, the first app approved by the Food and Drug Administration to use CBT to treat insomnia. A nine-week course of treatment using Somryst costs $899.

Meanwhile, Click is currently developing an app — CT152 — to treat major depressive disorder with cognitive therapy.

"Psychotherapy is expensive and a big time commitment," Brian Iacoviello, assistant professor of psychiatry at the Icahn School of Medicine at Mount Sinai — who helped develop CT152 — said in 2017. "It's good to have another option that is not medication."

Leon Mueller, the CEO of Bloom — another app that offers CBT for $60 a year — also told Business Insider: "What CBT does is it gives you the therapeutic tools so you can do therapy with yourself. It empowers you to be your own therapist."

Bloom's course centers around a guide called Mike who takes the user through exercises, "similar to an Ayahuasca ceremony," Mueller said.

"It's a bit like Peloton for the mind, without the hardware part anyway," he added.

The 'perfect storm'

Dr. John Torous, who leads the American Psychiatric Association's work evaluating mental-health apps, told Business Insider: "We know that psychological treatments are often very effective for many conditions. Realizing how we can digitize these therapies is extremely important."

That work is well underway, said Pear CEO Corey McCann, and the pressures of the pandemic indicate that now is the time to normalize it.

"Because of COVID we've certainly seen an uptick in the needs for these products. We've definitely seen access to these treatments decrease and we've also seen triggers for these conditions increase," he said.

"I think that is sort of a perfect storm."

Can apps work as well as medication?

Unlike many of its peers, Pear's Somryst, Click's CT125, and Orexo's Deprexis — an app that treats depression with CBT — make their claims of efficacy based on evidence from yearslong clinical trials.

This means they require more oversight from regulators, but also means they're proven to work, and more likely to be adopted by clinicians and covered by health-insurance companies.

"We're looking at primary outcomes that are the same that a drug would be targeting," David Benshoof Klein, Click's CEO and cofounder, told Business Insider. "Because they are meaningful, but also so that payers, providers, and patients really understand what we're doing and what they're getting."

Those working on digital mental-health solutions say the demand is there because antidepressants aren't getting better at the rate they used to and, while they are lifesaving for many, they can come with debilitating side effects.

"The more revolutionary, innovative, safe, and, frankly, more effective treatments for a wide variety of different mental-health disorders are in my view more likely to be digital than chemical," Klein said.

"How much pharmacotherapy innovation is really happening in the depression space?"

Orexo CEO Nickolaj Sørensen also told Business Insider: "A hundred years back, a lot of medications were mixed by the pharmacist and the hospitals."

"Now it's the turn of the more interactive digital therapies."

Regulators want to fast-track app therapies — but are still working out how to screen them

Compared to pharmacotherapy, the digital mental-health space is nascent, and regulators have been playing catchup, quickly forming guidance so that people can get the help they needed, safely.

While developers are sold on their efficacy and salience, "regulatory agencies are still learning how to evaluate these products," said Torous of the American Psychiatric Association.

In the face of the COVID-19 crisis, the FDA has expedited its evaluation process, allowing more apps and software to be accessed by the public.

On April 14, 2020, the FDA opened up a loophole for software treating psychiatric disorders, swiftly allowing patients with schizophrenia temporary access to the prescription-only Pear-004 app.

EndeavorRx, a prescription-only video game that treats ADHD in children, was approved by the FDA via another pathway, the De Novo scheme, soon after.

And in September, the FDA set up a new division, the Digital Health Center of Excellence, to accelerate the development of its digital therapy policy.

Bakul Patel, the center's Director for Digital Health, told Business Insider that the FDA had been working to formulate app and software guidance since 2015, but this year has accentuated the need to speed it up.

"People are creating all these very interesting and innovating apps and we've been continuously providing that clarity," he said.

Standards of evidence can vary wildly

One problem for these new apps is that many of their peers don't need FDA approval and have already been uploaded to app stores with little evidence behind them, said Haim of the NIMH.

Often, these apps claim efficacy based on small-size studies, or make vague claims altogether, thereby ducking regulatory hurdles, he said. He did not name any of these apps.

"We're aware that commercial entities are developing things that, in some cases, have very little evidence base," he said. "If they do have evidence base, they aren't being delivered in such a way, and may not be effective."

"That's challenging, as there are tens of thousands of apps out there — and consumers for them."

A paper published in the Frontiers in Psychiatry journal in November 2019 found that just 3.41% of anxiety and depression apps on Apple's App Store and Google's Play Store "had research to justify their claims of effectiveness" with "the majority of that research undertaken by those involved in the development of the app."

Extra concerns about user data

App developers collect sensitive personal data about their users, and often sell it to third parties to generate revenue.

In the mental-health space, data is often extremely intimate, so the rise of such apps have rightly prompted concern about privacy. There is also often a gap between what data the users of mental-health apps think they have agreed to hand over, and what is actually taken.

"Cambridge Analytica kind of warned people that we have to be careful," Torous said, referring to the scandal over the Facebook personality tests that were used to harvest data of US voters in 2016.

The FDA said it is committed to ensuring developers value user privacy.

"Safety is definitely one of the biggest aspects of what we look for. When I say safety, I mean privacy and security," said Patel of the FDA's digital center. "A loss of information leading to harm is something we really care about."

However, both Haim and Patel stressed that the benefits of collecting patient data in the mental-health space could be huge.

"It's a double-edged sword," Haim said. "The amount of data that can be collected passively, it's amazing, and it provides the opportunity to leverage that data in a meaningful way."

"If they can leverage data while maintaining privacy, that's a really important sign that you wouldn't want to ignore."

Beating the stigma

Discussions around mental health are more normalized than they ever were, but the stigma around asking for help looms large.

So receiving a therapy that has been greenlit by regulators, on a person's own terms, is therefore extremely attractive.

"It's easier to be more private with this stuff, right? I think in mental health inevitably there's this certain need to be more private," BCG's Beyor told Business Insider. 

"People are more open to the computer than they are to their therapist," Orexo's Sørensen added.

The distracted generation

One concern shared by experts and developers is that, from experience, people rarely complete courses of therapy on apps, unless supported by a human clinician.

"Sustained engagement is a huge, huge issue," Haim, of the NIMH, told Business Insider. "Someone might download the app … but then the vast majority of individuals that download the app don't use it."

"For those that do use it, they may use it for one or two sessions and, since there's not that clinician involvement, they lose interest."

Developers and regulators will also have to consider the fact that starting a course of therapy on an app could — as in real life — often unearth trauma and put people at risk without the support network they need.

Other issues are more subtle. The main problem Bloom has right now, according to its CEO, is the lack of diversity among its virtual therapists.

"We don't have a female guide in the app," Mueller said. "Mike, our guide, is male and white, and so that doesn't resonate with everyone."

"That's why we're launching new guides very soon."

New, convenient solutions to mental health are sorely needed

One thing developers, scientists, and experts all agree on is that millions of people aren't getting the treatment they need.

Sixty percent of American adults diagnosed with a mental illness had not received any treatment in the year leading up to 2018, according to data from the National Alliance on Mental Illness.

"The vast majority of individuals who have mental illness don't seek, or aren't able to receive, effective treatment," Haim said, adding that apps offer a huge opportunity to solve the issue.

Click's Klein echoed the sentiment, saying: "There's a very high percentage of people with unmanaged mental-health disease that can be significantly addressed through digital."

The practice of visiting a clinic once a week for a 50-minute session is also over, the CEOs said.

"That's outdated not just because of COVID, but because people don't operate in that space anymore," Haim said.

All signs indicate that apps offering therapy courses will become as widespread of prescription drugs and in-person therapy — and that regulators are welcoming them with open arms.

Editor's note: This story has been updated to clarify that the FDA has permitted Deprexis to be approved temporarily and that EndevourRx was approved through the FDA's De Novo pathway.

Watch: What could be the fastest way to end the coronavirus crisis?

ncG1vNJzZmivp6x7o8HSoqWeq6Oeu7S1w56pZ5ufonyusc2tmKVlmJqurcDHZpqroaOewG6tz6lkm5mjmrFuwMeeqZqoqWKzpa2Mqaqym5ierrW%2ByKyrrGViZX9xeZBq