A Novel Digital Behavioral Therapy Reduces Fibromyalgia Severity: Results of the PROSPER-FM RCT

Behavioral therapies, such as Acceptance and Commitment Therapy (ACT), have been empirically supported for treating fibromyalgia (FM). However, clinical adoption is challenging due to limited access to qualified providers. A smartphone-based, FDA cleared prescription digital therapy (FM-ACT) addresses this barrier by providing self-guided ACT for treatment of FM symptoms. We report the effectiveness of FM-ACT from PROSPER-FM (NCT05243511), a pivotal randomized controlled trial (RCT). The trial randomized 275 participants with FM to receive 12 weeks of FM-ACT or an active comparator (Symptom Tracker (ST), designed as a daily symptom tracker/monitor with access to patient education materials). The primary endpoint was Patient Global Impression of Change (PGIC) at Week 12. Secondary endpoints (collected weekly) included the Revised Fibromyalgia Impact Questionnaire (FIQ-R), Pain Intensity, Pain Interference, and Sleep Interference. At week 12, 70.6% of the FM-ACT participants improved on PGIC (vs 22.2% in the ST control, p < 0.001). The FM-ACT arm improved significantly more on FIQ-R total score than the ST control (p < 0.001, Effect Size = 0.65). Superiority of FM-ACT emerged early (between Weeks 2 and 7) on FIQ-R total and domain scores, Pain Intensity, and Pain Interference. FM-ACT was superior to ST control on virtually all endpoints at Week 12. No treatment related adverse events were observed. Results from the pivotal RCT demonstrated that FM-ACT offers clinical benefits in improving wellbeing, lowering FM severity, and reducing common FM symptoms. Clinical benefits started to display a few weeks into the therapy.