Smartphone-Based App Demonstrates Clinical Benefits in Fibromyalgia Management

R Michael Gendreau, MD, PhD

Credit: LinkedIn

The smartphone-based digital therapeutic application, FM-ACT, proved statistical superiority over the control regarding fibromyalgia symptoms, impact, function, and wellbeing, in addition to common conditions associated with fibromyalgia, according to data presented at the American College of Rheumatology’s 2023 Convergence in San Diego, California.¹

“Acceptance and Commitment Therapy (ACT), a form of guideline-recommended Cognitive Behavioral Therapy (CBT), has been empirically validated as a non-drug treatment for fibromyalgia,” wrote lead investigator R Michael Gendreau, MD, PhD, Gendreau Consulting, LLC, and colleagues. “However, clinical adoption of the therapy has been limited partly due to availability of qualified providers as a major barrier.”

To help tackle this barrier to access, FM-ACT, recently approved by the US Food and Drug Administration (FDA), was designed to deliver self-guided ACT for the treatment of symptoms related to fibromyalgia. Preliminary clinical benefits of the prescription digital application have been observed in a pilot randomized controlled trial, which was previously covered on HCPLive. In the analysis, patients using FM-ACT reported 84% positive ratings in “Ease of Use” and 88% had positive experiences regarding “Interface and Satisfaction.” Additionally, mHealth App Usability Questionnaire (MAUQ) results showed high ratings in the “Adequate Information on Progress” and “Easy to Learn” categories.²

In this prospective, multicenter, randomized controlled trial, PROSPER-FM, patients who met the American College of Rheumatology’s 2016 criteria for fibromyalgia were randomized to receive either 12 weeks of FM-ACT or a digital symptom tracker control. Patients were able to continue using any ongoing fibromyalgia treatments. The application was comprised of 42 structured ACT lessons, activities aimed to encourage behavior changes and exercise, and mindfulness practices. Patients in the control group were offered daily symptom tracking as well as fibromyalgia education materials.

The primary endpoint was the Patient Global Impression of Change (PGIC), while secondary endpoints focused on the Revised Fibromyalgia Impact Questionnaire (FIQ-R), pain interference and intensity, and sleep interference. These endpoints were obtained on a weekly basis through electronic patient-reported outcomes (ePROs).

Of the 591 patients assessed for eligibility, 275 patients were ultimately enrolled and randomized to receive FM-ACT (n = 140) or the symptom tracker (n = 135). The mean age of patients was 49 years, most were White (83%), and most were female (94.3% in the FM-ACT group and 92.6% in the symptom tracker group). Baseline fibromyalgia characteristics and baseline FIQ-R were comparable among arms. During the follow-up period, 20 patients in the FM-ACT cohort and 5 patients in the symptom tracker cohort discontinued the intervention.

At the 12-week mark, 70.6% of patients in the FM-ACT cohort observed an improvement on PGIC compared with only 22.2% of patients in the symptom tracker cohort (P <.001). Additionally, patients receiving the FM-ACT intervention had significantly greater post-treatment reductions in their FIQ-R total scores when compared with the symptom tracker intervention (-9.1 vs -1.1, respectively; P <.001, Effect Size = .65). The digital therapeutic application was also statistically superior on all measures, including pain intensity and interference, the Beck Depression Inventory II (-3.6 vs -.1, respectively), committed action (CAQ-8), Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Sleep Disturbance, and the Psychological Inflexibility in Pain Scale (PIPS). There were no treatment-related adverse events during the study period.
“Validated digital ACT therapy provided by FM-ACT, combined with the low-risk safety profile of this device-based intervention, offers an important step forward in reaching and benefiting the broader fibromyalgia population with a non-drug therapy,” investigators concluded.

References

1. ^{GendreauM, ChadwickA, McCrackenL, Williams D, et al. Digital Acceptance and Commitment Therapy Improves Fibromyalgia Outcomes: Results from a Pivotal, Multi-center, Randomized Controlled Trial. Presented at: American College of Rheumatology Convergence 2023. San Diego, CA. November 10-15, 2023.}
2. ^{Pine, L. (2023a, March 2). Digital Behavioral therapy app aims to help manage patients with fibromyalgia. HCP Live. https://www.hcplive.com/view/digital-behavioral-therapy-app-aims-to-help-manage-patients-with-fibromyalgia}