When it comes to treating mental health and behavioral disorders, there have traditionally been two choices: medication and psychotherapy/behavioral interventions. Get ready for a third option: digital health devices, software and applications collectively known as "digital therapeutics."
These therapies aim to treat a variety of diseases and disorders, from asthma and diabetes to depression and attention-deficit hyperactivity disorder. Some digital therapeutics are designed to be used in conjunction with medication or behavioral interventions. Others aim to replace traditional treatments altogether. Examples include web-based cognitive-behavioral therapy (CBT) programs, digital dashboards that allow patients and providers to closely track indicators of health, and even game-based interventions.
What the therapies have in common is a commitment to evidence-based medicine. Unlike most wellness apps marketed directly to consumers, digital therapeutics follow an R&D path that looks more like drug development. The tools are evaluated in clinical studies and prescribed by a medical provider. And many of the companies producing digital therapies are seeking regulatory approval.
Mental and behavioral disorders lend themselves particularly well to digital interventions, suggests psychologist Colin Espie, PhD, a professor of sleep medicine at the University of Oxford and co-founder and chief medical officer of the digital therapeutics company Big Health. "Digital medicine is really personalized behavioral medicine," he says.
Mobile CBT
Big Health centers on a web-based program called Sleepio, an evidence-based intervention that uses CBT for insomnia, or CBT-I. Instead of being delivered in an office by a psychologist, Sleepio’s six-week intervention is led by an animated virtual sleep expert named The Prof and his narcoleptic dog Pavlov. "It’s designed to feel entertaining, but it’s actually full-octane CBT," Espie says.
He and his colleagues tested the intervention in a randomized, placebo-controlled trial of people with chronic insomnia. More than 70 percent of participants who completed the online CBT intervention had healthy sleep eight weeks after the program ended, compared with less than 30 percent of participants who received a placebo in the form of visualization exercises (Sleepopens in new window, Vol. 35, No. 6, 2012). Further randomized controlled trials have been published since then, including a study of more than 3,700 participants that showed improving sleep also improves mental health (The Lancet Psychiatryopens in new window, Vol. 4, No. 10, 2017).
Big Health is working with more than two dozen self-insured corporations in the United States to offer Sleepio to their employees. The aim, Espie says, is to close a treatment gap. Guidelines from groups such as the American College of Physicians indicate that CBT-I should be first-line treatment for people with chronic insomnia, but there aren’t enough providers to meet the demand. "Anyone in America with chronic insomnia can go to the doctor and get a sleeping pill, but they very seldom have access to CBT," says Espie. "Our goal is to create a new digital medicine that can replace sleeping pills."
Other companies are designing tools that patients and their health-care providers will use collaboratively. For example, Pear Therapeutics, a company based in Boston and San Francisco, is developing prescription-based digital treatments for substance use disorder, post-traumatic stress disorder, generalized anxiety disorder and schizophrenia.
In 2017, Pear’s reSET therapy for the treatment of substance use disorders became the first prescription digital therapeutic for disease treatment cleared by the Food and Drug Administration (FDA). A similar product for the treatment of patients with opioid use disorder, reSET-O, to be used in combination with the medication buprenorphine, is now under review by the FDA. In April, Pear announced a deal with Sandoz, a division of the health-care company Novartis, to commercialize the two products.
reSET centers around a mobile app that leads patients with alcohol, cocaine, marijuana and stimulant use disorders through CBT-based tools and allows them to track substance use, cravings and triggers such as social pressure and loneliness. The system requires a physician’s prescription, but it’s designed for patients who are undergoing outpatient therapy for treatment of their substance use disorder. Clinicians such as psychologists or psychiatrists who are working with those patients can log on to a dashboard to access a patient’s data and monitor his or her progress. The application also comes with a label, akin to a prescription drug label, that contains instructions for clinicians about how to integrate the tool into their therapeutic practice, says Yuri Maricich, MD, MBA, Pear’s chief medical officer.
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igh-quality CBT for substance abuse treatment is time-intensive and intentionally repetitive so that patients can strengthen the neural circuits involved in resisting the substance of misuse, Maricich says. With reSET, patients can undertake the straightforward components of the treatment on their own and focus in-person therapy on more complicated issues, such as exploring why particular settings cause cravings. "Rather than focusing on the more rote aspects of treatment, clinicians can work with patients on the areas where they’re struggling," Maricich says. "reSET isn’t psychoeducation or self-help. It’s an actual treatment intended to improve outcomes and enhance the therapeutic alliance between the patient and the clinician."
Stamp of approval
As digital therapeutics and other new technologies gain in popularity, the FDA is tasked with determining how best to evaluate them. Software that aims to diagnose or treat medical conditions falls under the category of medical devices. But because such software is so different from existing devices, the route to approval isn’t straightforward. The reSET system was evaluated through a "de novo" premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are so novel they have no equivalents on the market.
Recognizing the need for a better approach, in 2017 the FDA published a Digital Health Innovation Action Planopens in new window and launched a new Software Precertification Pilot Program to develop a regulatory model for software technologies. The pilot program will evaluate digital health companies, including manufacturers of digital therapeutics, and certify companies to go through a more streamlined review. Precertified companies could potentially send low-risk products to market without a specific product review.
"This pilot program is the first step in redesigning how the FDA regulates digital health products," says Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health.
Requiring a prescription and seeking FDA approval involve extra effort for developers of digital therapeutics, but those efforts are worth it to ensure patient safety, Maricich says. When treating high-risk conditions such as substance use disorder, patients can face significant harm from treatments that don’t do what they claim, he adds. An official stamp of approval indicates that the digital therapeutic has been rigorously evaluated. "All medications and devices need to be evaluated to make sure they’re safe and effective. There’s no reason to presume that software is any different," Maricich says. "Patients and clinicians deserve no less." Regulatory approval is also an important step toward getting insurance companies to cover the costs of digital therapeutics, he adds. "Once a product is cleared by the FDA, it receives a code that facilitates reimbursement [by insurers]."
While regulatory and insurance wrinkles still need to be ironed out, digital medicine pioneers say it’s only a matter of time before physicians are regularly prescribing digital therapeutics. "I don’t think we’re far from an environment where digital medicine is a first-line option," Espie says. "Technology is a part of modern medicine, and a part of its future."
