Fibromyalgia
Conditions
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.
Interventions
DEVICEDigital ACT
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.
Sponsors
Swing Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Participant is 22 to 75 years of age, inclusive 2. Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM 3. Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. 4. Participant is capable of reading and understanding English and has provided written informed consent to participate. Key
Exclusion criteria
1. Lifetime history of bipolar or other psychotic disorder 2. Severe depression at screening (measured by BDI-II) 3. 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) 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Change (PGIC) response rate | Week 12 |
Countries
United States
Outcome results
None listed