Fibromyalgia & musculoskeletal pain
Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial
Primary result · Improvement on PGICResult — go to the resultDifference in proportions 48.4% 95% CI 37.9–58.9Authors' conclusion
Digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients.
Study context
- Population
- Adults aged 22–75 years with FM, 25 US community sites257 women and 18 men
- Participants
- 275 adults
- Comparison
- 12-week self-guided smartphone-delivered digital and commitment therapy (ACT) vs active control
- Digital ACTn = 140
- Active controln = 135reference
- Primary endpoint
- Patient global impression of change (PGIC) response rate
- Follow-up
- Week 12
Methodological detailsmulticentre (25 US community sites), active-controlled, blind-to-hypothesis, 1:1 randomisation in permuted blocks of four, open-label for research staff, Research staff not masked to group allocation, Randomised 1:1 via web-based system in permuted blocks of four at site level
- Multicentre (25 US community sites)
- Active-controlled
- Blind-to-hypothesis
- 1:1 randomisation in permuted blocks of four
- Open-label for research staff
- Research staff not masked to group allocation
- Randomised 1:1 via web-based system in permuted blocks of four at site level
Primary result
Improvement on PGIC · 12 weeks
Difference in proportions
48.4%
95% CI 37.9–58.9
P < 0.0001
Events by treatment group
Digital ACTvs Active control
difference in proportions 48.4% (95% CI 37.9–58.9); P < 0.0001
As reported in the abstract
Safety
- No device-related safety events were reported
Original publication
Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial. Lancet. Published 8 July 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →