The field of “digital therapeutics,” software designed for diagnosing and treating mental health disorders, is coming into its own
Society’s reliance on technology has reached unprecedented heights during the COVID-19 pandemic. People have had to rely on their computers and smartphones to complete routine errands, to work and attend school, and even to access health care. This has set the stage for the rise of digital therapeutics—evidence-based digital interventions to prevent, manage, or treat medical disorders or diseases. And psychologists can help shape this burgeoning field.
Experts still don’t fully agree on a definition of digital therapeutics. But most use the term to describe software or digital applications that go beyond mere “wellness” apps that people can download to help with meditation or losing weight, for example. What sets digital therapeutics apart is that they’re designed to treat a disease, and some of them are accessible by prescription only. Since 2017, the U.S. Food and Drug Administration (FDA) has certified half a dozen digital therapeutics for diagnosing and treating mental and behavioral health conditions, including attention-deficit/hyperactivity disorder (ADHD), cognitive impairment, and substance use disorders. While that number is small, many more digital mental health interventions—hundreds, maybe thousands—exist in a regulatory gray area, available to consumers without specific FDA approval or a prescription.
Digital behavioral health companies who create these interventions drew $2.4 billion in venture funding in 2020 alone, according to venture fund Rock Health. But even as the money is pouring in, many questions remain, including how well digital therapeutics work, how they should be regulated, their place in the health care system, and what influence they will have on the practice of psychotherapy. While many of these tools function as an alternative to psychotherapy, they are based on psychological science—and experts argue that psychologists should play a prominent role in their development, approval, and use.
“The world has changed, and people are using remote technologies in almost every aspect of their lives, including for psychological services,” said psychologist Jonathan Comer, PhD, director of the Mental Health Interventions and Technology Program at Florida International University and a founding chair of the mHealth Working Group of APA’s Society of Clinical Psychology (Div. 12) Presidential Task Force on Technology and Mental Health. “It’s happening whether psychologists are on board or not. We can either opt out or be a part of how people engage with these wellness resources.”
What’s regulated and what’s not
The promise of digital mental health tools is their potential to reach so many people. “We have an enormous supply and demand problem in mental health. There are many more people who want services than there are professionals available to provide them—and not by a small margin,” said Stephen Schueller, PhD, an associate professor of psychological science and informatics at the University of California, Irvine, and executive director of One Mind PsyberGuide, a website that reviews digital mental health apps.
But there are many dots to connect before the promise of digital therapeutics is reached. “Everyone agrees it’s early days for the field,” said John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center in Boston. “The intention is good, but we don’t really know how well these things work.”
To date, only a handful of digital therapeutics have been submitted for FDA clearance, a signal to consumers and providers that the intervention is safe and effective. The first—reSET, a prescription digital therapeutic by Pear Therapeutics used to treat substance use disorder—was approved in 2017 through a regulatory pathway for low- to moderate-risk medical devices. Recognizing the need for a better approach, the FDA created the Software Precertification Program (Pre-Cert). The program aimed to streamline review of software-based medical devices based on the seriousness of the condition and the level of risk presented by the app.
It’s a good start, Torous said, but he has argued that more detailed regulatory guidelines are needed. He and his colleagues simulated how the Pre-Cert framework would apply to top health apps in the United States and were unable to identify a standard measure that would differentiate apps requiring regulatory review from those that would not (Alon, N., et al., JMIR mHealth and uHealth, Vol. 8, No. 10, 2020). “The system might work well for conditions such as diabetes or hypertension that have well-demarcated lines between health and wellness,” he said. “But it doesn’t seem overly practical for apps to treat mental health conditions, which are more personal and dynamic and can’t be measured with routine biomarkers.”
The FDA seems to recognize the need for a more comprehensive approach to digital health technologies. In 2020, the agency launched a Digital Health Center of Excellence to coordinate research, support developers, and help reframe its regulatory approach to digital health technology.
Meanwhile, many digital therapeutics developers are moving forward without seeking FDA clearance. They can do so because the agency has stated it will exercise “enforcement discretion” for certain software functions, including mobile apps. This category of regulation stipulates requirements related to labeling, safety, and quality but doesn’t include a specific clearance process. Under this policy, many software programs for mental and behavioral health can be marketed without explicit FDA approval. Software that fall into this category include apps that provide psychoeducation, offer motivational guidance, or help people with diagnosed psychiatric conditions practice coping skills.
“By far, the majority of digital therapeutics for mental and behavioral health fall under FDA enforcement discretion,” said Jenna Carl, PhD, chief medical officer at digital therapeutics company Big Health and current chair of the Div. 12 mHealth Working Group. But because no one is regulating these interventions, even the experts aren’t quite sure how many are out there—or how well an individual product might work.
Promise and pitfalls
For digital therapeutics company Big Health, the decision to delay pursuing product claims that require FDA approval was a strategic move to improve access to safe and effective interventions for common mental health issues, Carl said. FDA-cleared digital therapeutics such as reSET require a prescription from a physician—a barrier that prevents many people from connecting with apps that could help them. “Most people with mental health conditions don’t actually talk to their provider about them,” Carl said. And even if they do seek help, most mental health care providers can’t legally prescribe medication. “The prescription barrier means most mental health care providers can’t provide access to these behavioral solutions,” she said.
Big Health’s products, including Sleepio for sleep improvement and Daylight for worry and anxiety, are modeled on cognitive behavioral therapy (CBT) and have research to back them up. A randomized controlled trial of Daylight, for instance, found that 71% of users achieved remission of generalized anxiety disorder, compared with 33% of those in a control group (Carl, J. R., et al., Depression & Anxiety, Vol. 37, No. 12, 2020). Though Big Health designs these apps for patients to use on their own, they can be integrated into psychotherapy, said Carl, a clinical psychologist. “I might be working with someone with anxiety who also has sleep difficulties. By recommending they use Sleepio, we don’t have to spend part of our hour going over their sleep diary and can instead focus on the parts of care that are better done in person.”
Big Health has made its two programs available to nearly 10 million users in the United Kingdom and the United States. In the United Kingdom, patients have access through the National Health Service. In the United States, access mostly comes through agreements with large, self-insured employers who offer the apps to their employees with the hope they will help bring down health care costs. Other insurers are beginning to take notice. Managed-care consortium Kaiser Permanente has now integrated digital therapeutic apps into its electronic record system, allowing physicians and therapists to refer patients to free tools for mindfulness, meditation, and CBT.
An analysis of the Kaiser program found that patients had greater engagement with the tools when they were integrated into the care system and recommended by clinicians (Mordecai, D., et al., NEJM Catalyst Innovations in Care Delivery, Vol. 2, No. 1, 2021). “Evidence suggests that you get better outcomes when a mental health professional and client use these tools together,” Torous said.
Still, most patients interested in digital therapeutics are using the tools on their own, rather than with the help of their health care providers, said David Mohr, PhD, director of the Center for Behavioral Intervention Technologies at the Northwestern University Feinberg School of Medicine. In 2019, he cohosted a series of meetings on digital mental health in collaboration with the Banbury Center, a science think tank at Cold Spring Harbor Laboratory in New York. The participants—including researchers and representatives from insurance companies and large health care organizations as well as self-employed insurers—concluded that the evidence base for digital mental health is strong, particularly for common mental health problems such as depression and anxiety. But there are significant barriers to implementation, they found, in part because providers have no way to be reimbursed for using digital therapeutics with patients (Psychiatric Services, advance online publication, 2021). “Without a reimbursement mechanism, there’s no way to roll this out for most of American health care,” Mohr said.
The piecemeal approach to regulating digital therapeutics also poses problems for safety and privacy. Data collected by consumer-facing apps may not be subject to the same Health Insurance Portability and Accountability Act (HIPAA) protections as data collected by providers. And there are potential harms to patients from using unproven apps to treat mental health conditions, Schueller said. One app he evaluated, for example, recommended an evening cocktail as a primary strategy for regulating mood. Fortunately, such egregious, dated advice seems to be rare, he said. But a bigger risk may be that people choose poorly designed apps in place of evidence-based interventions. “Someone might download these apps, not get better, and think, ‘There’s nothing out there that can help me,’” Schueller said. “They may avoid therapy or delay treatment as a result.”
The role of psychologists
Schueller created One Mind PsyberGuide to help consumers find digital tools that work. The review site evaluates products based on information about their evidence base, user experience, and policies related to data security and privacy. Torous, too, has attempted to make sense of the growing digital therapeutics marketplace by creating the M-Health Index and Navigation Database (MIND), which rates apps in four categories: privacy/data security, evidence, user engagement, and integration into care (Lagan, S., et al., npj Digital Medicine, Vol. 3, 2020). APA, too, reviews the latest apps and tools for practicing psychologists in its quarterly “Let’s Get Technical” column.
Such efforts help consumers and providers make sense of a confusing marketplace. But nobody expects these tools to replace experts. “Many of these apps aren’t as good as therapist-led treatments, but they fill a separate need,” Comer said. “Therapists can make large changes but reach a small number of people. A lot of the promise of digital mental health apps is that we can now also reach larger numbers of people, even if some of those effects are small. The combination of the two is how we move the needle at the population level.”
Digital mental health tools may work best when used in a stepped care model, added Mohr. He and his colleagues developed an internet-based CBT (iCBT) program for depression and tested it in an exploratory trial. The iCBT program included periodic check-ins with a psychotherapist, and those users who weren’t responding to the initial intervention were stepped up to phone-based CBT with a therapist. After 5 weeks of treatment, patients had significant reductions in depression severity—on par with improvements seen in a control group that received a teletherapy intervention (Nicholas, J., et al., Journal of Affective Disorders, Vol. 281, 2021). “There was no difference in outcomes, but the stepped care model with iCBT used about half of the therapists’ time,” Mohr said. In other words, each provider could reach twice as many people.
How to integrate digital health tools into health care models will be one of the most important challenges to address as the field continues to grow. “This is a murky space,” Schueller said. “Psychologists should be using their voices to make sure it’s figured out in a way that protects privacy, safety, and security, and benefits the individuals who might be impacted by these tools.”
As part of that effort, APA is taking steps to stay ahead of the curve. This year, the association created the Office of Health Care Innovation to address issues in emerging technologies, including a strategic approach for addressing digital therapeutics in psychological care. APA has also partnered with the FDA as a member of the agency’s Network of Digital Health Experts, with the goal of allowing psychologists to have more input on the regulation of digital therapeutics.
While some psychotherapists might see these tools as a threat, Carl believes it’s more helpful to focus on their potential. “Other medical professionals are happy to take advantage of these tools. There’s a risk in psychologists not seeing this as an opportunity,” she said. “And the industry wants psychologists—including research psychologists and clinicians—to be involved.”
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