Positive clinical results for fibromyalgia behavioural therapy treatment

The digital therapeutics company Swing Therapeutics has announced positive results following the clinical trial of its behavioural therapy solution for fibromyalgia.

The US company has reported early results from a prospective single-arm clinical trial, presented at the American College of Rheumatology (ACR) annual meeting.

Stanza, a prescription smartphone-based digital therapeutic, was developed by Swing Therapeutics for the management of fibromyalgia – a condition that causes widespread musculoskeletal pain, fatigue, sleep, memory and mood issues.

The core of the treatment is acceptance and commitment therapy (ACT), a type of cognitive behavioural therapy (CBT) with proven efficacy in treating the disorder.

The company says Stanza is designed to help adult patients manage the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness.

“This real-world data expands the growing body of clinical evidence supporting the use of digital therapeutics for the management of fibromyalgia, and reinforces the positive outcomes observed from a previous randomised controlled trial,” said Mike Rosenbluth, founder and CEO of Swing Therapeutics.

“As we gather additional compelling evidence, our mission is to make digital behavioural therapeutics like Stanza become more accessible to people with fibromyalgia.

“The launch of Swing Care – a Texas-based clinic focused on the treatment of fibromyalgia – is an exciting step toward broadening the reach of telemedicine and digital health to a wider population of patients.”

Andrea Chadwick, medical director of Swing Care, said: “People living with fibromyalgia often fall through the cracks of healthcare and better solutions are needed to improve the quality of their lives. This clinical data demonstrates the power of digital behavioural therapeutics to make a meaningful difference.”

Swing Therapeutics looked at the clinical impact of a digital behavioural therapy for fibromyalgia management in a decentralised trial where participants were primarily evaluated using the Patient Global Impression of Change (PGIC) Scale.

At the end of the course of a 12-week therapy, participants with fibromyalgia achieved improvement in all areas measured, with 84 per cent of them reporting improvement in their condition after Stanza treatment.

Yifei Dai, head of clinical and scientific affairs at Swing Therapeutics, said: “People with fibromyalgia have no cure for their condition, and often have trouble managing symptoms, including pain, brain fog, sleep disturbances and anxiety and depression.

“I’m encouraged by the results we saw from patients throughout the study and look forward to gathering additional evidence.”

Swing Therapeutics also reported results of usability research on Stanza that was conducted as part of the REACT-FM trial. 

In this study, participants evaluated the treatment’s ease of use, interface, and overall satisfaction via the mHealth App Usability Questionnaire (MAUQ) at the end of the 12-week treatment.

Treatment preference for the digital therapeutic application versus medication management was evaluated for participants who currently or previously used FDA-approved pharmacological treatments for fibromyalgia.

At the end of the programme, 84 per cent and 88 per cent of participants reported positive ratings in the MAUQ domains of ease of use and interface and satisfaction, respectively.

The company found that approximately 90 per cent of those who had used FDA-approved fibromyalgia medications preferred treatment with Stanza, or Stanza combined with approved fibromyalgia medication, versus treatment with approved medication alone.

Nelson Mitchell, head of product at Swing Therapeutics, said: “Other self-guided digital behavioural therapies on the market have been created to address accessibility and scalability issues, but many have low engagement due to poor usability.

“We’re encouraged by the positive results from this study that support our therapy’s usability and satisfaction for fibromyalgia management.”