BACKGROUND: International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. We aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.
METHODS: In the PROSPER-FM randomised clinical trial conducted at 25 US community sites, adult participants aged 22-75 years with fibromyalgia were recruited and randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Randomisation was done with a web-based system in permuted blocks of four at the site level. We used a blind-to-hypothesis approach in which participants were informed they would be randomly assigned to one of two potentially effective therapies under evaluation. Research staff were not masked to group allocation, with the exception of a masked statistics group while preparing statistical programming for the interim analysis. The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat. The trial was registered with ClinicalTrials.gov, NCT05243511 (now fully closed).
FINDINGS: Between Feb 8, 2022, and Feb 2, 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135). At 12 weeks, 99 (71%) of 140 ACT participants reported improvement on PGIC versus 30 (22%) of 135 active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9-58·9; p<0·0001). No device-related safety events were reported.
INTERPRETATION: Digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients.
FUNDING: Swing Therapeutics.
| Discipline Area | Score |
|---|---|
| Psychologist |  |
| Physician | |
Physician rater
An RCT about a digitally guided therapeutic app in the personal symptom management of fibromyalgia showing a significant benefit versus the control group.
Physician rater
Interesting research to open up accessibility for a common disease, with an alredy proven but unaccessible treatment
Physician rater
This telematic form of CBT has proven effective for a certain segment of the population that may not have significant economic difficulties in attending in person. It is an alternative worth considering.
Physician rater
Which clinical disciplines treat fibromyalgia? Not all. Most likely very few pain physicians in this community do.
Psychologist rater
The results support fibromyalgia patients' use of ACT delivered via a mobile device app. The treatment group reported functional improvement with treatment.
Psychologist rater
The study follows a well-designed, comprehensive research. I appreciated the acknowledgment that differences in outcome between ACT and CBT have not been established by research. However, this study certainly suggests that ACT, even when delivered digitally, is a viable psychological approach to chronic pain.
Psychologist rater
These are promising results about an intervention more accessible to more patients. However, a reduction of one point in a 0-11 scale after 42 sessions of treatment suggests that there is still room for improvement.
, McMaster University