NCT05243511

Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Swing Therapeutics, Inc. · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 weeks.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	Digital ACT	Participants in this arm receive Digital ACT as well as standard of care.
OTHER	Digital Symptom Tracker	Participants in this arm complete a digital symptom and function tracker and monitor, are provided access to digital fibromyalgia and health education, and receive standard of care.

Timeline

• Start date: 2022-02-08
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2022-02-17
• Last updated: 2023-06-15

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study