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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
275
Participants in this arm receive Digital ACT as well as standard of care.
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.
Site #37
Covina, California, United States
Patient Global Impression of Change (PGIC) response rate
Time frame: Week 12
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Site #15
Oceanside, California, United States
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San Bernardino, California, United States
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Thousand Oaks, California, United States
Site #36
Tujunga, California, United States
Site #35
Whittier, California, United States
Site #13
Orlando, Florida, United States
Site #33
St. Petersburg, Florida, United States
Site #25
Atlanta, Georgia, United States
Site #21
Covington, Louisiana, United States
...and 15 more locations