The digital mental health space was growing rapidly even before the COVID-19 pandemic but stress and anxiety brought on by the health crisis have accelerated demand for virtual behavioral health services.
The success of digital mental health startups means that more people can access mental wellness than were potentially able to do so before.
“I think the benefits are clear. We can increase access to care, at our fingertips, and we can hopefully personalize care to our exact needs. There is the potential to provide care that is more affordable, personalized and accessible,” John Torous, M.D. director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston told Fierce Healthcare.
Broadly, the digital mental health space includes direct-to-consumer apps, such as Talkspace and Calm, apps that are designed for a clinician to prescribe, such as reSET, which is used to treat substance use disorders and also mental health platforms that work with employers and health plans, such as Ginger, Lyra Health and Modern Health.
There are more than 380,000 health apps available through Apple and Android operating systems, and around 20,000 of them address mental health, according to the European Connected Health Alliance.
But with the market growing rapidly, some experts are concerned about whether digital mental health tools deliver what they promise.
“There is still much we do not know about how the tech part works and for whom,” said Torous, also an associate professor of psychiatry at Harvard Medical School.
“With direct-to-consumer advertising and marketing, companies will sometimes exaggerate what these apps can do. They will take a small pilot study and extrapolate that it can work for huge populations,” said Torous, whose research focuses primarily on direct-to-consumer apps.
Some investors have raised concerns about the potential downsides of venture backed-digital health companies and the risks to patients.
“It’s frustrating if you’re a customer of an expense report SaaS startup and the company goes out of business, but it’s potentially devastating if your tele-therapist or addiction counselor suddenly disappears because the platform that employed them ran out of money,” wrote Hunter Walk, a partner at venture capital firm HomeBrew in a blog post earlier this year. “This is my most significant concern about the wave of mental wellness startups being funded with venture dollars — what happens to the clients of the ones which fail?
Modern Health co-founder Erica Johnson made serious allegations about the company she helped launch in a lawsuit she filed against co-founder Alyson Watson and the company after she was fired in 2019.
Johnson, who filed suit for wrongful termination, retaliation and defamation, claimed in the lawsuit that Modern Health, under Watson’s leadership, mispresented its capabilities, such as the size of its provider network, to potential customers and investors. This alleged misrepresentation “puts at serious risk the lives and health” of Modern Health’s patients, she said in the lawsuit.
Modern Health strongly denies the allegations. In a statement to Fierce Healthcare, a Modern Health spokesperson said the claims “have no basis in reality since an independent committee of the board of directors of Modern Health concluded after a comprehensive investigation that the derivative claims lack merit.”
Leading companies try to set the bar
Leading digital health companies that have made inroads in the employer and payer markets are well aware of the need for accountability and aim to set high standards.
Many of these companies rely on clinically validated measures, such as the Patient Health Questionnaire (PHQ) and Generalized Anxiety Disorder (GAD) screeners to assess symptom improvement for anxiety, depression, and other common mental health issues. And leading companies in the market also say they build their products on evidence-based approaches and invest in research to support their therapies.
But with thousands of digital mental health tools on the market, many companies in the space are not doing enough to provide validation for their products, according to Adam Chekroud, co-founder and chief product officer of Spring Health.
“There are a few outlier companies that are committed to clinical validation but in general, the incentives are pretty low for companies to commit to real validation and invest in it,” he said.
As the market rapidly grows, the upside is that digital mental health is getting much-needed investment, said Myra Altman, Ph.D., a clinical psychologist and the vice president of clinical care at Modern Health.
“But it also makes me nervous because I don’t know that all those companies have mental health experts that work there. I don’t know if they have research and assessment experts that work there so you run this risk of having non-validated tools out there,” she said.
“We’ve invested a ton of time in building that foundation that is based on evidence and evaluate it with repeated assessment and academic research that we have under review,” Altman said. “The field certainly can and should be doing more in that area and we are investing in that heavily here so we can help set the tone of what that should look like in the mental health space.”
Connie Chen, M.D., chief medical officer at Lyra Health, also has concerns about whether all companies in the market are meeting high standards.
“I worry about the general standard in digital health broadly and particularly mental health. I think we see companies making clams that may and or may not be sustainable by internal data at scale. They can take a small subset of the population and position it as telling the story or they are talking about clinical measures that are not clinically meaningful,” Chen said.
Lyra Health has an internal research team and has partnered with several academic institutions on a series of research papers, Chen said. The company also uses “reliable clinical improvement” to measure patients’ success with treatment.
Chekroud says Spring Health has published over 30 peer-reviewed papers in medical journals, tracks patients’ results during treatment and launched a new product to measure the quality of its provider network in real-time.
“Ultimately, you’re a healthcare company, and healthcare is all about safety and outcomes,” Chekroud said. “Are digital mental health companies measuring safety and clinical outcomes? Do they track them using gold standards? Do they publish their results in top medical journals so that world experts can verify and validate those processes? How well are they designing those studies? Ultimately, digital mental health companies will earn trust and respectability over time by publishing their proof and showing receipts for the value they drive.”
For patients and consumers, the stakes are high. If someone looks for treatment and has a negative experience with a digital mental health tool, that is a missed opportunity and could lead to a delay in care.
“As a field, we make a commitment to high-quality care and that raises the bar for everyone else. If there are companies taking a lax approach to evidence-based rigors that builds mistrust in the field as a whole, so there’s a social responsibility among the organizations,” Altman said.