Swing Therapeutics, a digital therapeutics company developing evidence-backed treatments for chronic pain conditions, announced the publication of new research data supporting the long-term effectiveness of Stanza, its digital therapeutic that delivers behavioral therapy for fibromyalgia management. The results, from an extension of a prospective single-arm clinical trial (REACT-FM), were presented at the U.S. Association for the Study of Pain annual meeting, April 11-14, 2023.
Stanza is a prescription smartphone-based digital therapeutic designed to help adult patients manage the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness. The core of the treatment is Acceptance and Commitment Therapy (ACT), a type of Cognitive Behavioral Therapy (CBT) with proven efficacy in treating fibromyalgia.
“Fibromyalgia patients benefit from therapies that can make a meaningful difference, not just in the near-term, but over the long-term,” said Mike Rosenbluth, Ph.D., founder and CEO of Swing Therapeutics. “Compared to pharmaceutical-based treatments, behavioral therapies have the potential to make lasting changes in how patients experience and process chronic pain and other symptoms. With this long-term clinical data, we are demonstrating Stanza as a convenient, effective fibromyalgia treatment with lasting impact on patient outcomes.”
In the decentralized, single-arm, real-world extension study, fibromyalgia patients continued to use Stanza as needed for therapy maintenance after the main 3-month treatment program, and were evaluated up to 12 months after their treatment initiation. The USASP publication presented the follow-ups at 3, 6, 9 and 12 months.
The results showed durable clinical effectiveness of the treatment, evidenced by the maintenance of the immediate treatment effect at Month 3 through to Month 12. Specifically, the proportion of patients improved in fibromyalgia (measured by Patient Global Impression of Change) was consistently above 80% across all follow-up timepoints. The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score also demonstrated substantial and durable improvement, reporting greater than 25% mean improvement across the extension study.
Long-term improvements were also reported on other common fibromyalgia-related symptoms, including pain intensity, pain interference, and sleep interference. In addition, the extension study demonstrated lasting relief in clinical depression and anxiety, as well as improvement on patients’ overall quality of life). Specifically:
- Substantial reduction in the proportion of patients with clinical anxiety (measured by Generalized Anxiety Disorder 7) from 83% at baseline to 31% in Month 3 and stayed consistent at 28% in Month 12
- Substantial reduction in the proportion of patients with clinical depression (measured by Beck Depression Inventory II) from 64% at baseline to 11% in Month 3 and maintained at 22% in Month 12
- Major increase in the proportion of the patients with satisfactory quality of life, from 22% at baseline, to 54% at Month 3 and maintained at 56% at Month 12
The newly published research data further confirm the positive clinical impact of Stanza, suggesting that durable outcomes may be expected for up to 12 months. The full publication can be accessed here.
Stanza 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. Swing Care, an online clinic focused specifically on the treatment of fibromyalgia, includes digital therapeutics as a care option.