San Francisco-based company Big Health touted the results of a study that found its app for insomnia helped patients with anxiety and depression.
They compared more than 1,000 people in the U.K. who either used the app with therapy, or used therapy alone. Those who used the Sleepio app in conjunction with therapy saw a greater improvement in their anxiety or depression, according to results published in Behaviour Research and Therapy.
Specifically, 65 percent of Sleepio users saw their GAD-7 and PHQ-9 scores reduced below the clinical threshold, compared to 58 percent in the control group.
But the study, which was funded in part by Big Health, also had some significant limitations. All of its authors either worked for Big Health or were paid consultants of the company.
It also wasn’t randomized or blinded, as all participants were offered the opportunity to use the app. Of about 3,500 people who were offered the option to use Sleepio, just 552 signed up, and 510 were included in the final results. They were compared to a subset of 510 people who had opted not to use the app.
As a result, “it could be argued that those who exercised the choice to take up Sleepio were more motivated generally to persevere with their mental health goal,” researchers noted in the paper.
They tried to mitigate this bias by matching people in the control group with the intervention group based on certain characteristics, including mood.
Also, fewer minorities used the app, accounting for just 10% of the intervention group. A little over 66% of Sleepio’s users were female.
Sleepio uses sleep restriction, cognitive exercises, and walks users through “sleep hygiene” to help them get a better night’s rest. The app is CE marked, but is not yet FDA cleared. In the U.S., people can only access it through their employer’s health plan.
The company also has a competitor in Pear Therapeutics’ Somryst, which was FDA cleared last year. But like other digital therapeutics companies, it’s still working out the best way to win over reimbursement, as demonstrated by recent filings.
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