SAN FRANCISCO– Swing Therapeutics, a digital therapeutics company developing evidence-backed treatments for autoimmune and chronic pain conditions, today announced the presentation of research supporting the use of its digital therapeutic to deliver behavioral therapy for fibromyalgia management. Swing Therapeutics reported early results from a prospective single-arm clinical trial (REACT-FM), which were presented at the American College of Rheumatology (ACR) annual meeting last week.
Swing Therapeutics has developed Stanza, a prescription smartphone-based digital therapeutic for fibromyalgia management. The core of the treatment is acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy (CBT) with proven efficacy in treating fibromyalgia. Stanza is designed to help adult patients manage the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness. It was made available to patients in September 2022 under the FDA’s Digital Health Enforcement Policy for Digital Health Devices, and is available by prescription via a healthcare provider.
“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 randomized controlled trial,” said Mike Rosenbluth, Ph.D., founder and CEO of Swing Therapeutics. “As we gather additional compelling evidence, our mission is to make digital behavioral therapeutics like Stanza become more accessible to people with fibromyalgia. The launch of Swing Care is an exciting step toward broadening the reach of telemedicine and digital health to a wider population of patients.”
Swing Care, an online clinic focused specifically on the treatment of fibromyalgia, launched in Texas in 2022 to focus on holistic treatment for fibromyalgia patients, and includes digital therapeutics as a care option.
“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 behavioral therapeutics to make a meaningful difference. Swing Care has partnered with Swing Therapeutics to expand access through telehealth to specialized, clinically proven fibromyalgia treatment that otherwise has only been available from a limited number of providers,” said Andrea Chadwick, M.D., a globally recognized expert on the treatment of fibromyalgia and Medical Director of Swing Care. “With Swing Care, patients will receive personalized treatment plans that meet their unique needs, including access to behavioral therapies like Stanza and medication management as needed.”
In this study, participants were primarily evaluated using the Patient Global Impression of Change (PGIC) Scale. Other outcomes collected include the Revised Fibromyalgia Impact Questionnaire (FIQ-R), as well as instruments that measure pain intensity and interference, sleep interference, depression, anxiety, pain acceptance, mindfulness, and quality of life (QoL). Outcomes were measured after 12 weeks of using the app, and then analyzed against baseline scores for all completed participants.
At the end of the course of a 12-week therapy, participants with fibromyalgia achieved improvement in all areas measured. Eighty-four percent of participants reported improvement in their fibromyalgia condition after Stanza treatment, with 47 percent reporting to be “much” or “very much” improved.
“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,” said Yifei Dai, Ph.D., Head of Clinical and Scientific Affairs at Swing Therapeutics. “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 Stanza’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 12-week program, 84 percent and 88 percent of participants reported positive ratings in the MAUQ domains of ‘Ease of Use’ and ‘Interface and Satisfaction’, respectively. Approximately 90 percent of participants who had used FDA-approved fibromyalgia medications preferred treatment with Stanza, or Stanza combined with approved fibromyalgia medication, versus treatment with approved medication alone.
“Other self-guided digital behavioral therapies on the market have been created to address accessibility and scalability issues, but many have low engagement due to poor usability,” said Nelson Mitchell, Head of Product at Swing Therapeutics. “We’re encouraged by the positive results from this study that support our therapy’s usability and satisfaction for fibromyalgia management.”
