Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
- Conditions
- Fibromyalgia
- Registration Number
- NCT05243511
- Lead Sponsor
- Swing Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
- Participant is 22 to 75 years of age, inclusive
- Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM
- Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
- Participant is capable of reading and understanding English and has provided written informed consent to participate.
Key
- Lifetime history of bipolar or other psychotic disorder
- Severe depression at screening (measured by BDI-II)
- The participant is at increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS")
- Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) response rate Week 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Site #37
🇺🇸Covina, California, United States
Site #15
🇺🇸Oceanside, California, United States
Site #31
🇺🇸San Bernardino, California, United States
Site #38
🇺🇸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
🇺🇸Saint Petersburg, Florida, United States
Site #25
🇺🇸Atlanta, Georgia, United States
Site #21
🇺🇸Covington, Louisiana, United States
Scroll for more (15 remaining)Site #37🇺🇸Covina, California, United States