This text was initially revealed on HCP Stay®.
The smartphone-based digital therapeutic software, FM-ACT, proved statistical superiority over the management relating to fibromyalgia signs, influence, perform, and wellbeing, along with frequent situations related to fibromyalgia, in keeping with information offered on the American School of Rheumatology’s 2023 Convergence in San Diego, California.1
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“Acceptance and Dedication Remedy (ACT), a type of guideline-recommended Cognitive Behavioral Remedy (CBT), has been empirically validated as a non-drug remedy for fibromyalgia,” wrote lead investigator R Michael Gendreau, MD, PhD, Gendreau Consulting, LLC, and colleagues. “Nonetheless, scientific adoption of the remedy has been restricted partly resulting from availability of certified suppliers as a significant barrier.”
To assist deal with this barrier to entry, FM-ACT, just lately accepted by the FDA, was designed to ship self-guided ACT for the remedy of signs associated to fibromyalgia. Preliminary scientific advantages of the prescription digital software have been noticed in a pilot randomized managed trial, which was beforehand coated on HCP Stay. Within the evaluation, sufferers utilizing FM-ACT reported 84% optimistic scores in “Ease of Use” and 88% had optimistic experiences relating to “Interface and Satisfaction.” Moreover, mHealth App Usability Questionnaire (MAUQ) outcomes confirmed excessive scores within the “Ample Data on Progress” and “Straightforward to Be taught” classes.2
On this potential, multicenter, randomized managed trial, PROSPER-FM, sufferers who met the American School of Rheumatology’s 2016 standards for fibromyalgia had been randomized to obtain both 12 weeks of FM-ACT or a digital symptom tracker management. Sufferers had been capable of proceed utilizing any ongoing fibromyalgia remedies. The applying was comprised of 42 structured ACT classes, actions aimed to encourage conduct adjustments and train, and mindfulness practices. Sufferers within the management group had been supplied each day symptom monitoring in addition to fibromyalgia training supplies.
The first endpoint was the Affected person International Impression of Change (PGIC), whereas secondary endpoints targeted on the Revised Fibromyalgia Impression Questionnaire (FIQ-R), ache interference and depth, and sleep interference. These endpoints had been obtained on a weekly foundation by digital patient-reported outcomes (ePROs).
Of the 591 sufferers assessed for eligibility, 275 sufferers had been in the end enrolled and randomized to obtain FM-ACT (n = 140) or the symptom tracker (n = 135). The imply age of sufferers was 49 years, most had been White (83%), and most had been feminine (94.3% within the FM-ACT group and 92.6% within the symptom tracker group). Baseline fibromyalgia traits and baseline FIQ-R had been comparable amongst arms. Throughout the follow-up interval, 20 sufferers within the FM-ACT cohort and 5 sufferers within the symptom tracker cohort discontinued the intervention.
On the 12-week mark, 70.6% of sufferers within the FM-ACT cohort noticed an enchancment on PGIC in contrast with solely 22.2% of sufferers within the symptom tracker cohort (P<.001). Moreover, sufferers receiving the FM-ACT intervention had considerably larger post-treatment reductions of their FIQ-R complete scores in comparison with the symptom tracker intervention (-9.1 vs -1.1, respectively; P<.001, Impact Dimension = .65). The digital therapeutic software was additionally statistically superior on all measures, together with ache depth and interference, the Beck Melancholy Stock II (-3.6 vs -.1, respectively), dedicated motion (CAQ-8), Affected person-Reported Outcomes Measurement Data System (PROMIS) Fatigue and Sleep Disturbance, and the Psychological Inflexibility in Ache Scale (PIPS). There have been no treatment-related antagonistic occasions throughout the research interval.
“Validated digital ACT remedy supplied by FM-ACT, mixed with the low-risk security profile of this device-based intervention, presents an vital step ahead in reaching and benefiting the broader fibromyalgia inhabitants with a non-drug remedy,” wrote the investigators.
References
1. Gendreau M, Chadwick A, McCracken L, Williams D, et al. Digital acceptance and dedication remedy improves fibromyalgia outcomes: outcomes from a pivotal, multi-center, randomized managed trial. Introduced at: American School of Rheumatology Convergence 2023. November 10-15, 2023; San Diego, CA.
2. Pine L. Digital Behavioral remedy app goals to assist handle sufferers with fibromyalgia. HCP Stay. March 2, 2023. Accessed December 1, 2023. https://www.hcplive.com/view/digital-behavioral-therapy-app-aims-to-help-manage-patients-with-fibromyalgia.
