The multicenter, randomized controlled trial tested Stanza, a smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy recommended by international clinical guidelines for fibromyalgia management, with the results of the study published July 8 in The Lancet.

Fibromyalgia is a chronic pain condition that affects an estimated 10 million Americans, a majority of whom are women. The condition is characterized by widespread pain and other physical and cognitive symptoms that include fatigue, disrupted sleep, reduced physical function, memory problems and difficulty concentrating (“brain fog”). It is often accompanied by anxiety and depression.

The Phase 3 PROSPER-FM trial clinically validated Stanza’s benefits, including improvements in well-being, fibromyalgia severity and major fibromyalgia symptoms, including pain intensity, pain interference, fatigue, sleep disturbance, depression and physical function. This study is the largest medical device study for fibromyalgia ever undertaken.

“For the millions of people with fibromyalgia, the publication of this data in The Lancet and the clear results represent an answer to the urgent need for effective therapies to help manage their symptoms,” said Lesley Arnold, MD, study principal investigator and professor emerita at the University of Cincinnati College of Medicine. “Few large-scale studies over the last two decades have shown clinical benefit of novel treatments for this underrecognized and underserved condition.”

In the 12-week trial, 275 participants were randomized to receive either Stanza treatment or a digital symptom tracker control. At week 12, 70.6% of participants in the Stanza arm reported an improvement on Patient Global Impression in Change, which measures patient well-being.

Stanza also exhibited statistically greater improvement compared to the control on fibromyalgia-related symptoms, function and impact, as well as pain intensity, pain interference, fatigue, sleep disturbance and depression, with no treatment-related adverse events observed.

“Fibromyalgia options are typically limited to a handful of pharmacological interventions that have limited efficacy and that can come with difficult-to-manage side effects,” said Mike Rosenbluth, CEO of Swing. “This publication validates Stanza as a guideline-directed non-drug approach that many patients previously couldn’t access due to few available trained clinicians, geographic limitations and cost.