Researchers found that self-guided behavioural therapy through the Stanza app led to significant improvements for patients with fibromyalgia. CREDIT Photo/Swing Therapeutics

New research conducted by the University of Cincinnati and Swing Therapeutics revealed that self-directed smartphone-based behavioural therapy resulted in substantial improvements for individuals with fibromyalgia.

The multicenter, randomized controlled trial tested Stanza, a smartphone app that delivers acceptance and commitment therapy (ACT). International clinical guidelines recommend this type of therapy for fibromyalgia management.

Fibromyalgia is a chronic pain condition that affects an estimated 10 million Americans, with a majority of sufferers being women. The condition is characterized by widespread pain, as well as physical and cognitive symptoms such as fatigue, disrupted sleep, reduced physical function, memory problems, and difficulty concentrating (referred to as “brain fog”), and is often accompanied by anxiety and depression.

Lesley Arnold, MD. CREDIT Photo/University of Cincinnati

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

“According to Dr. Lesley Arnold, the publication of this data in The Lancet and the clear results provide a much-needed answer for the millions of people with fibromyalgia who are seeking effective therapies to manage their symptoms. As the study principal investigator and professor emerita at the University of Cincinnati College of Medicine, she emphasizes that there have been few large-scale studies in the last two decades demonstrating the clinical benefit of new treatments for this underrecognized and underserved condition.”

In a 12-week trial, 275 participants were randomly assigned to receive either Stanza treatment or a digital symptom tracker control. At the end of the 12 weeks, 70.6% of participants in the Stanza group reported an improvement in their well-being as measured by the Patient Global Impression of Change.

Stanza showed significant improvement in fibromyalgia symptoms compared to the control group, with no observed adverse events.

“Fibromyalgia treatment options are usually limited to a few medications that have limited effectiveness and can have challenging side effects,” said Mike Rosenbluth, CEO of Swing. “This publication confirms that Stanza, a non-pharmacological approach aligned with guidelines, is a viable option for many patients who previously couldn’t access it due to a lack of trained clinicians, geographical limitations, and cost.”ns, and cost.”