Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management (PROSPER-FM)

Swing Therapeutics

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Other: Digital Symptom Tracker

Device: Digital ACT

Study type

Interventional

Funder types

Other

Identifiers

NCT05243511

Swing-005

Details and patient eligibility

About

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.

Enrollment

275 patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.