This article was first published HCP Live®.
According to data presented at the American College of Rheumatology’s 2023 Convergence, the smartphone-based digital therapy application FM-ACT can treat fibromyalgia symptoms, effects, and symptoms in addition to common symptoms associated with fibromyalgia. They were shown to be statistically superior to controls in terms of function and health status. Located in San Diego, California.1
““Acceptance and Commitment Therapy (ACT), a type of cognitive behavioral therapy (CBT) recommended by the guidelines, is an empirically validated non-pharmacological treatment for fibromyalgia,” said Principal Investigator Gendreau Consulting, LLC. writes R Michael Gendreau, MD. , and colleagues. “However, clinical adoption of this therapy has been limited, in part because availability of qualified health care providers remains a major barrier.”
To address this access barrier, FM-ACT, recently approved by the FDA, was designed to provide self-induced ACT for the treatment of symptoms associated with fibromyalgia. Preliminary clinical benefits of digital prescription applications have been observed in pilot randomized controlled trials. HCP Live. The analysis found that 84% of patients using FM-ACT had a positive rating regarding “ease of use” and 88% reported a positive experience regarding “interface and satisfaction”. did. Furthermore, the results of the mHealth App Usability Questionnaire (MAUQ) showed high ratings in the “adequate information about progress” and “easy to learn” categories.2
In this prospective, multicenter, randomized controlled trial, PROSPER-FM, patients meeting the American College of Rheumatology’s 2016 fibromyalgia criteria were randomized to receive either 12 weeks of FM-ACT or digital symptom tracking control. was assigned to. The patient was able to continue his ongoing fibromyalgia treatment. The application consisted of 42 structured ACT lessons, activities aimed at promoting behavior change and movement, and mindfulness practices. Patients in the control group were provided with daily symptom tracking and fibromyalgia education materials.
The primary endpoint was 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. Ta. These endpoints were obtained weekly through electronic patient-reported outcomes (ePRO).
Of 591 patients assessed for eligibility, 275 patients were ultimately enrolled and randomized to receive FM-ACT (n = 140) or symptom tracker (n = 135). Ta. 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 her FIQ-R were comparable between groups. During the follow-up period, 20 patients in the FM-ACT cohort and 5 patients in the symptom tracking cohort discontinued the intervention.
At 12 weeks, PGIC improvement was observed in 70.6% of patients in the FM-ACT cohort compared to only 22.2% of patients in the symptom tracker cohort (P<.001). Furthermore, patients who received the FM-ACT intervention had a significantly reduced post-treatment FIQ-R total score compared to the symptom tracker intervention (-9.1 vs. -1.1, respectively). P<.001, effect size = .65). Additionally, digital therapeutic applications have been tested for pain intensity and interference, Beck Depression Inventory II (-3.6 vs. -0.1, respectively), Commitment Action (CAQ-8), Patient-Reported Outcomes Measurement Information System ( PROMIS) fatigue and sleep disturbances, and Psychological Inflexibility in Pain Scale (PIPS). There were no treatment-related adverse events during the study period.
“The validated digital ACT therapy offered by FM-ACT, combined with the low-risk safety profile of this device-based intervention, provides non-pharmacological therapy and its benefits to a broader range of fibromyalgia patients. “This is an important step forward in improving health outcomes,” the researchers wrote. .
References
1. Gendreau M, Chadwick A, McCracken L, Williams D, et al. Digital acceptance and commitment therapy improves outcomes in fibromyalgia. This is the result of an important multicenter randomized controlled trial. Presentation location: American College of Rheumatology Convergence 2023. November 10-15, 2023. San Diego, California.
2. Pine L. Digital behavioral therapy app aims to help manage fibromyalgia patients. HCP Live. March 2, 2023. Accessed December 1, 2023. https://www.hcplive.com/view/digital-behavioral-therapy-app-aims-to-help-manage-patients-with-fibromyalgia.