Digital Behavioral Therapy App Aims to Help Manage Patients with Fibromyalgia

Data presented at the American College of Rheumatology Convergence 2022 indicated that the use of the smartphone-based digital behavioral therapy app, Stanza, which focused on the acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy (CBT), considered a gold-standard treatment, has been proven to be effective in the management of fibromyalgia. Results are derived from a decentralized, single-arm clinical trial, REACT-FM. The app, initially made available in September 2022, was designed to help patients manage psychological symptoms that patients with fibromyalgia often experience, including sleep issues, anxiety, and depression.

Fibromyalgia, a chronic and debilitating condition, commonly presents as widespread pain, physical, and cognitive symptoms. Unfortunately, it often manifests differently among patients and can be difficult to diagnose and treat.

“People living with fibromyalgia often fall through the cracks of healthcare, and better solutions are needed to improve the quality of their lives,” Andrea Chadwick, MD, a globally recognized expert on the treatment of fibromyalgia and Medical Director of Swing Care, noted. “This clinical data demonstrates the power of digital behavioral therapeutics to make a meaningful difference.”

The first study determined the clinical impact of the digital behavioral therapy app, in which patients were evaluated at baseline using the Patient Global Impression of Change (PGIC) Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), pain acceptance, pain intensity and interference, sleep interference, anxiety and depression, quality of life (QoL), and mindfulness. Measurements were reevaluated at 12 weeks and compared to scores at baseline.

Of the 32 patients with fibromyalgia who completed the trail, 84% reported improvement in their disease state and 47% experienced “much” or “very much” improvement. There were also improvements shown in all areas measured, including sleep interference, pain severity and interference, QoL, and psychological wellbeing.

The study was limited by the small sample of patients and the lack of a control cohort.

The next study assessed the usability and acceptability of the app for managing the symptoms of fibromyalgia. Participants using the investigational smartphone-based self-guided digital ACT application for FM (FM-ACT) reported 84% positive ratings in “Ease of Use” and 88% had positive experiences regarding “Interface and Satisfaction.” mHealth App Usability Questionnaire (MAUQ) results showed high ratings in the “Adequate Information on Progress” and “Easy to Learn” categories. However, “Comfortable to use in a Social Setting” was rated the lowest. The app was deemed both relevant (8.3/10) and worthwhile (8.4/10) among patients. The majority of participants (90%) preferred the app or a combination of the app and pharmacotherapy when compared with pharmacotherapy alone.

Usability and satisfaction results indicate that this app may be useful in delivering behavioral therapy for the management of fibromyalgia.

Similar to the previous study, the small cohort size limited the study, in addition to the possibility of the impact of missing data for those who ended the study before the 12-week mark.

“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,” Mike Rosenbluth, PhD, founder and CEO of Swing Therapeutics, concluded. “As we gather additional compelling evidence, our mission is to make digital behavioral therapeutics like Stanza become more accessible to people with fibromyalgia.”