Jun 17, 2020 7:00 AM

The Therapist Is In—and It's a Chatbot App

Companies rush to offer digital help for psychiatric disorders, after the FDA relaxes its rules amid the Covid-19 pandemic.

Illustration of person in therapy sessions talking to phone

A deadly new virus circling the globe makes many people more anxious. The pandemic’s psychological toll can be particularly weighty for people with an existing mental health condition. One 25-year-old on the US East Coast seeing a therapist for help with anxiety found additional support from an unexpected source: a chatbot.

“Therapy twice a month was fine before. It’s just now sometimes I have days where I feel like I need something extra,” says the person, who identifies as gender nonbinary and asked to remain anonymous. Their budget didn’t allow more frequent therapy sessions, making them receptive when a friend mentioned Woebot, a chatbot built on Stanford research that delivers a digital version of cognitive behavioral therapy. It has become essential. “Being able to turn to the app daily is very comforting,” they say. “It has taught me anxious traits and patterns of thought that I didn’t know about before.”

The Food and Drug Administration also thinks software can help people with the mental burdens of the pandemic. Covid-19 prompted the agency to give the concept a pandemic booster.

Since late 2017, the FDA has approved a handful of apps and digital services that doctors may prescribe for psychiatric disorders such as opioid abuse in a similar way to medication. The small industry was expected to grow fast as regulators and health care providers got more comfortable with the concept, and Woebot and others gathered clinical trial data needed to win approval.

Then in April the FDA suspended many of its usual rules for what it calls digital therapeutic devices for psychiatric disorders, to widen access to care during the pandemic. That freed doctors to prescribe digital therapy that hadn’t yet won approval and propelled companies to accelerate plans to develop and release apps.

One is Orexo, a Swedish pharmaceutical company that specializes in treatments for substance abuse and does most of its business in the US.

At the start of 2020, it expected to win FDA approval later this year for its first digital product—a cognitive-behavioral-therapy website for problem drinking called vorvida that trials showed can significantly reduce a person’s alcohol consumption. The company was preparing to start trials this fall of another site for opioid use, and was seeking to license a third for depression. “We’re now going to be launching all three this year,” says Dennis Urbaniak, head of Orexo’s digital therapeutics division. The company is working with insurers and health systems to offer vorvida to its first US patients outside a clinical trial within weeks. Urbaniak says the web therapy will be priced to be “competitive” with how insurers are billed for psychotherapy or counseling via video.

Pear Therapeutics, maker of three FDA-approved cognitive therapy apps for opioid use, chronic insomnia, and substance addiction, is accelerating work on a fourth app, for schizophrenia.

When the pandemic hit, the company was working toward clinical trials of the schizophrenia app, which includes exercises that help people question whether something they are experiencing is real or is a hallucination. CEO Corey McCann says Pear plans to release the app to some patients this fall, through partnerships with health providers and academic centers. He compares his company’s response to the FDA guidance for therapy apps to the compassionate-use program for remdesivir, the antiviral that won expedited approval for use in Covid-19 patients.

Evidence has mounted over the past decade that digital therapeutics can be as effective, or more effective, than treatment by doctors or therapists. Many are based on cognitive behavioral therapy, considered the gold standard for conditions including depression and anxiety.

CBT uses structured exercises to encourage a person to question and change their habits of thought—a format well suited to a step-by-step software guide or chatbot. Orexo, Woebot, and Pear say they personalize their services, steering patients to different exercises based on their answers to questions. Orexo’s Vorvida uses questions about a person’s drinking habits and path to treatment to tailor a program±for example, selecting exercises that can include guided meditation, creating a diary of consumption, and setting and tracking goals to reduce it. This week the FDA approved an app with a different format, a computer game called EndeavorRx from Akili Interactive that trials showed can help children with ADHD improve attention.

One benefit of digital treatment is that it can always be on hand, or in your pocket. People receiving conventional therapy rarely get a daily consultation, but a digital therapist on your phone makes it easier to keep up with homework and can provide support in urgent moments.

“Someone in the recovery process from substance use may be awake at 2 am feeling at high risk of relapse and not have anyone to talk to,” says Lisa Marsch, director of the Dartmouth Center for Technology and Behavioral Health, and a member of Pear’s scientific advisory board. “But they can have something in their pocket that helps them respond to that moment in a way that doesn’t include using again.”

The US has lagged other countries, such as Germany, in embracing computer therapy. The body that weighs clinical evidence for England’s National Health Service first recommended computerized cognitive behavioral therapy for depression, panic, and phobias in 2006, saying it could widen access to care.

Alison Darcy, CEO of Woebot and an adjunct lecturer in psychiatry at Stanford, says that argument carries weight in the US, too. The company has been offering its app as a form of self-care for people experiencing symptoms such as depression and anxiety for free since 2017 while it works towards FDA clearance; it now exchanges 4.7 million messages with people a week. “We just don’t have enough clinicians and specialists to treat everybody,” she says.

The 2018 National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration, found 48 million Americans with some form of mental illness, 60 percent of whom were not receiving treatment. Of the 20 million Americans with a substance use disorder, 90 percent weren’t getting any care.

The FDA didn’t sweep away all restrictions on psychiatric apps. April’s notice waived the requirement to submit clinical trial data but requires companies to establish security procedures, analyze the potential hazards for patients turning to their app, and advise people to first consult their doctor.

The policy is still an experiment. American Psychiatric Association guidance on mobile apps advises members to be cautious because digital therapies are new and “not what psychiatrists and mental health clinicians are classically trained to do.”

Bruce Rollman, director of the Center for Behavioral Health and Smart Technology at the University of Pittsburgh, says how doctors adapt to digital therapy will help determine the outcome of the FDA’s rule change. He worked on a trial funded by the National Institute of Mental Health, which found that people with depression and anxiety were helped more by a course of computerized CBT than by physicians’ usual care, and that the effect persisted six months later. But he cites another study as a reminder that the tech isn’t perfect. A randomized controlled trial with nearly 700 UK patients found computerized CBT didn’t produce better outcomes, mostly due to low engagement.

Rollman takes that as a reminder that doctors need to keep supporting patients receiving digital treatments, something relatively few physicians in the US have experience with. “You can’t just send people a link to a flashy digital app or website and expect that people are going to recover,” he says.