Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
NCT ID: NCT05243511
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
275 participants
INTERVENTIONAL
2022-02-08
2023-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Digital Acceptance and Commitment Therapy (ACT) Arm
Digital ACT
Participants in this arm receive Digital ACT as well as standard of care.
Digital Symptom Tracker
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.
Interventions
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Digital ACT
Participants in this arm receive Digital ACT as well as standard of care.
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
22 Years
75 Years
ALL
No
Sponsors
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Swing Therapeutics, Inc.
OTHER
Responsible Party
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Principal Investigators
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Michael Gendreau, MD
Role: STUDY_CHAIR
Consulting Chief Medical Officer
Lesley Arnold, MD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Site #37
Covina, California, United States
Site #15
Oceanside, California, United States
Site #31
San Bernardino, California, United States
Site #38
Thousand Oaks, California, United States
Site #36
Tujunga, California, United States
Site #35
Whittier, California, United States
Site #13
Orlando, Florida, United States
Site #33
St. Petersburg, Florida, United States
Site #25
Atlanta, Georgia, United States
Site #21
Covington, Louisiana, United States
Site #20
New Orleans, Louisiana, United States
Site #22
Prairieville, Louisiana, United States
Site #39
Chestnut Hill, Massachusetts, United States
Site #24
Ocean Springs, Mississippi, United States
Site #34
Brooklyn, New York, United States
Site #32
Scarsdale, New York, United States
Site #12
Williamsville, New York, United States
Site #27
Fargo, North Dakota, United States
Site #14
Cincinnati, Ohio, United States
Site #28
Dayton, Ohio, United States
Site #23
Tulsa, Oklahoma, United States
Site #16
Allentown, Pennsylvania, United States
Site #29
Austin, Texas, United States
Site #26
McKinney, Texas, United States
Site #30
Pflugerville, Texas, United States
Countries
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References
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Gendreau RM, McCracken LM, Williams DA, Luciano JV, Dai Y, Vega N, Ghalib Z, Guthrie K, Kraus AC, Rosenbluth MJ, Vaughn B, Zomnir JM, Reddy D, Chadwick AL, Clauw DJ, Arnold LM. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial. Lancet. 2024 Jul 27;404(10450):364-374. doi: 10.1016/S0140-6736(24)00909-7. Epub 2024 Jul 8.
Other Identifiers
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Swing-005
Identifier Type: -
Identifier Source: org_study_id
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