Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Digital ACT; Other: Digital Symptom Tracker

• 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

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Study Start: 2022-02-08
• Study First Posted: 2022-02-17
• Status Verified: 2023-02
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Acceptance and Commitment Therapy (ACT) Arm	Digital ACT	-
Digital Symptom Tracker	Digital Symptom Tracker	-

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) response rate	Week 12

Trial Locations

Locations (25)

Site #36; 🇺🇸 Tujunga, California, United States

Site #21; 🇺🇸 Covington, Louisiana, United States

Site #35; 🇺🇸 Whittier, California, United States

Site #32; 🇺🇸 Scarsdale, New York, United States

Site #16; 🇺🇸 Allentown, Pennsylvania, United States

Site #30; 🇺🇸 Pflugerville, Texas, United States

Site #28; 🇺🇸 Dayton, Ohio, United States

Site #27; 🇺🇸 Fargo, North Dakota, United States

Site #14; 🇺🇸 Cincinnati, Ohio, United States

Site #23; 🇺🇸 Tulsa, Oklahoma, United States

Site #29; 🇺🇸 Austin, Texas, United States

Site #26; 🇺🇸 McKinney, Texas, United States

Site #15; 🇺🇸 Oceanside, California, United States

Site #37; 🇺🇸 Covina, California, United States

Site #31; 🇺🇸 San Bernardino, California, United States

Site #38; 🇺🇸 Thousand Oaks, California, United States

Site #33; 🇺🇸 Saint Petersburg, Florida, United States

Site #13; 🇺🇸 Orlando, Florida, United States

Site #25; 🇺🇸 Atlanta, Georgia, United States

Site #22; 🇺🇸 Prairieville, Louisiana, United States

Site #39; 🇺🇸 Chestnut Hill, Massachusetts, United States

Site #20; 🇺🇸 New Orleans, Louisiana, United States

Site #24; 🇺🇸 Ocean Springs, Mississippi, United States

Site #12; 🇺🇸 Williamsville, New York, United States

Site #34; 🇺🇸 Brooklyn, New York, United States