NCT05243511CompletedPhase 3
"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Swing Therapeutics, Inc.25 sites in 1 country275 target enrollmentStarted: February 8, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Swing Therapeutics, Inc.
- Enrollment
- 275
- Locations
- 25
- Primary Endpoint
- Patient Global Impression of Change (PGIC) response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Digital Symptom Tracker
Active Comparator
Intervention: Digital Symptom Tracker (Other)
Digital Acceptance and Commitment Therapy (ACT) Arm
Active Comparator
Intervention: Digital ACT (Device)
Outcomes
Primary Outcomes
Patient Global Impression of Change (PGIC) response rate
Time Frame: Week 12
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (25)
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