Patients with fibromyalgia – a common condition causing chronic pain, fatigue, poor sleep, and cognitive dysfunction – could get relief from a digital therapeutic (DTx) based on cognitive behavioural therapy, according to a clinical trial.
The Stanza DTx – developed by Swing Therapeutics and delivered via smartphone – has been put through its paces in a prospective single-arm clinical trial called REACT-FM, presented at a recent American College of Rheumatology (ACR) congress.
Non-pharmacological interventions like CBT are generally recommended as first-line treatment for fibromyalgia, a complex disorder with no known cause, but these are usually delivered by a therapist – often in short supply in health systems around the world.
Stanza provides a form of CBT known as acceptance and commitment therapy (ACT), which according to Swing has been validated as an effective approach to managing fibromyalgia but is limited due to a lack of scalability.
“Self-guided digital behavioural therapies have been developed to address scalability and access issues, though some have had low engagement due to poor usability,” notes the ACR abstract for the study.
“A user-centred, engaging digital treatment designed for [fibromyalgia] patients has the potential to be clinically impactful on a broad scale,” it adds.
In the study, participants received 12 weeks’ therapy with Stanza, consisting of skill building lessons, mindfulness practices, and activities to encourage exercise and behavioural changes. Early results from 40 subjects at the data cut-off point showed that 84% reported improvement in symptoms, with 47% saying the were “much or very much improved.”
Benefits were seen across the spectrum of symptoms, including pain severity, sleep, and psychological well-being, according to the researchers, with participants also reporting improved quality of life.
Swing is conducting another randomised clinical trial – PROSPER-FM – which will compared Stanza to a control group in 300 patients. It is due to generate results next year.
Stanza was made available to patients in September under the FDA’s Digital Health Enforcement Policy for Digital Health Devices, set up to facilitate access to remote therapies during the pandemic. It is available on prescription from healthcare providers.
“People living with fibromyalgia often fall through the cracks of healthcare, and better solutions are needed to improve the quality of their lives,” said Andrea Chadwick, a specialist in chronic pain who serves as medical director of Swing Care – a virtual clinic set up by Swing earlier this year to provide treatment for patients with the disorder.
“This clinical data demonstrates the power of digital behavioural therapeutics to make a meaningful difference,” she added.