Faced with widespread skepticism about the value of digital therapies, Swing Therapeutics in early 2022 set out to make the strongest case possible for its app-based treatment for fibromyalgia.
In a year-long pivotal trial for Swing’s treatment, called Stanza, participants were told they were receiving one of two potentially effective treatments for fibromyalgia. Both groups received a smartphone app designed to look and feel similar, but just one of them guided users, in daily sessions over 12 weeks, through a cognitive behavioral therapy treatment designed to improve quality of life for people with the debilitating chronic pain condition. The other group only had access to health- and fibromyalgia-related educational materials and symptom tracking tools.
The use of a so-called sham application is considered among the most difficult controls that developers of digital treatments can employ to prove their interventions work. Just about any app you give a patient will have some therapeutic effect, so well-designed shams can be much harder to beat than alternatives, like a control group that receives treatment as usual or a waitlist control. But despite the expense and higher likelihood of failure that shams introduce, they are now a standard practice for companies that wish to submit their digital treatments to the Food and Drug Administration for review. Treatments cleared by FDA this year from Otsuka Pharmaceutical and Curio Digital Therapeutics both used sham controls.
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