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

"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

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 Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Digital ACT; Other: Digital Symptom Tracker

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicolette Vega

Study Locations

• United States
  • California
    • Covina, California, United States, 91722
      • Site #37
    • Oceanside, California, United States, 92056
      • Site #15
    • San Bernardino, California, United States, 92498
      • Site #31
    • Thousand Oaks, California, United States, 91360
      • Site #38
    • Tujunga, California, United States, 91042
      • Site #36
    • Whittier, California, United States, 90602
      • Site #35
  • Florida
    • Orlando, Florida, United States, 32801
      • Site #13
    • Saint Petersburg, Florida, United States, 33709
      • Site #33
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Site #25
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Site #21
    • New Orleans, Louisiana, United States, 70124
      • Site #20
    • Prairieville, Louisiana, United States, 70769
      • Site #22
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Site #39
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Site #24
  • New York
    • Brooklyn, New York, United States, 11235
      • Site #34
    • Scarsdale, New York, United States, 10583
      • Site #32
    • Williamsville, New York, United States, 14221
      • Site #12
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Site #27
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Site #14
    • Dayton, Ohio, United States, 45419
      • Site #28
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Site #23
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Site #16
  • Texas
    • Austin, Texas, United States, 78726
      • Site #29
    • McKinney, Texas, United States, 75070
      • Site #26
    • Pflugerville, Texas, United States, 78660
      • Site #30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital Acceptance and Commitment Therapy (ACT) Arm	Device: Digital ACT; Participants in this arm receive Digital ACT as well as standard of care.
Active Comparator: Digital Symptom Tracker	Other: Digital Symptom Tracker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Global Impression of Change (PGIC) response rate	Week 12

Collaborators and Investigators

• Sponsor: Swing Therapeutics, Inc.
• Investigators: Principal Investigator: Lesley Arnold, MD, Study Principal Investigator; Study Chair: Michael Gendreau, MD, Consulting Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Swing-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No