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From cars to digital mental health solutions: demand safety and effectiveness

As leaders in digital therapeutics, we aim to set an industry-wide standard of high-quality and transparent clinical evidence.

Imagine walking into an auto dealership and asking how a car performs on crash tests, only to be told that no such tests were ever conducted. “Does the car have any advanced safety features, like a forward-collision warning system?” you might ask. “Not that I know of,” the salesperson replies. Frustrated, you say: “Well, do the brakes work?” The salesperson pauses, thinking. “I’m sure they do. But you’ll have to give it a try to find out!”

That seems like an impossible scenario, but in reality, it is not that different from what a benefits team might experience when evaluating digital mental health solutions, often referred to as digital therapeutics (DTx).

The DTx space is growing rapidly, but most solutions do not have the quantity or quality of clinical evidence to support their claims of value, safety, or efficacy. What’s at stake is of greater consequence than ROI or engagement—employees’ well being depends on digital mental health making good on their claims.

As leaders in digital therapeutics, we aim to set an industry-wide standard of high-quality and transparent clinical evidence. Along the way, we want to empower benefits leaders to expect nothing short of “gold standard” clinical evidence from every vendor that claims to improve mental health. Not doing so will fail the individuals we all aim to help.

The consequence of ineffective mental health care

Using unproven, ineffective mental health care might not seem as dangerous as getting into a car with faulty brakes. But the truth is, giving a person who’s suffering from a mental health condition help that doesn’t work can have severe consequences.

That person will likely become disheartened that they aren’t getting better and distrustful of mental health care in general. Their suffering will continue, and their condition may worsen. Their untreated mental health symptoms will affect other aspects of their physical health, exacerbate comorbidities, and lead to mounting costs for employers, employees, and our healthcare system as a whole.

“The expectations for digital therapeutics are enormous because its promise is transformative — making mental health care better and more accessible by turning traditional approaches, which have left many without care, on their head,” said Jenna Carl, Vice President of Clinical Development and Medical Affairs at Big Health.“But that can only happen if digital therapeutics step up to the high standards of research and clinical evidence that are necessary for healthcare interventions to ensure their safety and effectiveness. Digital medicine must be taken as seriously as other forms of medicine, or we’ll risk peoples health and wellbeing.”

Use clinical evidence as a “test-drive”

Attempting to make sense of clinical evidence can be a real struggle, and unfortunately, you can’t take a mental health solution out for a quick drive to “test the brakes.” That’s why we created a digestible guide, “Choosing Wisely: Using Clinical Evidence to Evaluate Digital Therapeutics for Mental Health,” to walk you through what “evidence-based” means, what to look for in clinical research, and how to decipher good from poor quality evidence. Together we can ensure that high-quality clinical research is foundational to every digital mental health solution.

If you don’t have time to read the full guide, don’t stress. You can check out our blog, “Five questions you must ask before buying a digital mental health solution,” which highlights… well… the five questions you should ask every mental health vendor to “test drive” the quality of their clinical evidence.

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During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

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