Researchers have found that 71% of patients undergoing a self-guided digital acceptance and commitment therapy program for 12 weeks reported improvements in fibromyalgia symptoms compared with 22% of controls, according to a new study.
Fibromyalgia affects about 1.8% to 6.4% of the U.S. population—primarily women—and is characterized by widespread pain, fatigue, sleep disturbances, and cognitive difficulties. Although cognitive behavioral therapies such as ACT are recommended, access is limited because of a shortage of trained therapists and high costs.
In the multicenter, randomized, controlled phase III PROSPER-FM trial, published in The Lancet, the researchers evaluated the efficacy of a self-guided digital acceptance and commitment therapy (ACT) program, delivered via the Stanza application, at managing fibromyalgia. Conducted at 25 sites in the United States, the trial enrolled 275 adult patients aged 22 to 75 years with a fibromyalgia diagnosis. The participants were then randomized to either the digital ACT group (n = 140) or an active control group (n = 135), which provided daily symptom tracking and access to educational materials.
After a follow-up of 12 weeks, the researchers demonstrated that 99 of the participants in the digital ACT group reported improvements on the Patient Global Impression of Change scale compared with 30 in the control group (P < .0001). The primary endpoint showed a significant response rate favoring the digital ACT intervention. Further, the digital ACT group experienced statistically significant improvements in secondary outcomes, including a mean reduction in the Revised Fibromyalgia Impact Questionnaire total score by 10.3 points vs 2.2 points in the control group (P < .0001) and significant improvements in pain, fatigue, sleep disturbances, and depression—without any device-related adverse events.
The researchers reported that the digital ACT program improved accessibility by providing a self-guided treatment option. The participants had high engagement with the app, with 83% of them completing at least 75% of the core therapy program. Additionally, usability scores were favorable, with 84% of the participants rating the app easy to use and 76% of them satisfied with the interface.
In addition to the primary outcomes, secondary measures showed significant reductions in weekly pain intensity (mean difference = –0.68 points, P = .0010), weekly pain interference (mean difference = –0.74 points, P = .0011), and Patient-Reported Outcomes Measurement Information System Fatigue scores (mean difference = –3.2 points, P < .0001). Psychological flexibility, as measured by the Psychological Inflexibility in Pain Scale, also improved significantly (mean difference = –4.7 points, P < .0001).
The findings supported the safety and efficacy of a self-guided digital ACT program for fibromyalgia, showing statistically significant symptom improvement and enhanced accessibility.
Full disclosures can be found in the original study.