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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05243511
Recruitment Status : Active, not recruiting
First Posted : February 17, 2022
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Swing Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Digital ACT Other: Digital Symptom Tracker Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Actual Study Start Date : February 8, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) response rate [ Time Frame: Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05243511


Locations
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Sponsors and Collaborators
Swing Therapeutics, Inc.
Investigators
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Study Chair: Michael Gendreau, MD Consulting Chief Medical Officer
Principal Investigator: Lesley Arnold, MD Study Principal Investigator
More Information
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Responsible Party: Swing Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05243511    
Other Study ID Numbers: Swing-005
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases