Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
PROSPER-FM
"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
1 other identifier
interventional
275
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2022
CompletedStudy Start
First participant enrolled
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2023
CompletedJune 15, 2023
February 1, 2023
1.3 years
February 7, 2022
June 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Global Impression of Change (PGIC) response rate
Week 12
Study Arms (2)
Digital Acceptance and Commitment Therapy (ACT) Arm
ACTIVE COMPARATORDigital Symptom Tracker
ACTIVE COMPARATORInterventions
Participants in this arm receive Digital ACT as well as standard of care.
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Site #37
Covina, California, 91722, United States
Site #15
Oceanside, California, 92056, United States
Site #31
San Bernardino, California, 92498, United States
Site #38
Thousand Oaks, California, 91360, United States
Site #36
Tujunga, California, 91042, United States
Site #35
Whittier, California, 90602, United States
Site #13
Orlando, Florida, 32801, United States
Site #33
St. Petersburg, Florida, 33709, United States
Site #25
Atlanta, Georgia, 30329, United States
Site #21
Covington, Louisiana, 70433, United States
Site #20
New Orleans, Louisiana, 70124, United States
Site #22
Prairieville, Louisiana, 70769, United States
Site #39
Chestnut Hill, Massachusetts, 02467, United States
Site #24
Ocean Springs, Mississippi, 39564, United States
Site #34
Brooklyn, New York, 11235, United States
Site #32
Scarsdale, New York, 10583, United States
Site #12
Williamsville, New York, 14221, United States
Site #27
Fargo, North Dakota, 58104, United States
Site #14
Cincinnati, Ohio, 45219, United States
Site #28
Dayton, Ohio, 45419, United States
Site #23
Tulsa, Oklahoma, 74133, United States
Site #16
Allentown, Pennsylvania, 18104, United States
Site #29
Austin, Texas, 78726, United States
Site #26
McKinney, Texas, 75070, United States
Site #30
Pflugerville, Texas, 78660, United States
Related Publications (1)
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.
PMID: 38991582DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Gendreau, MD
Consulting Chief Medical Officer
- PRINCIPAL INVESTIGATOR
Lesley Arnold, MD
Study Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2022
First Posted
February 17, 2022
Study Start
February 8, 2022
Primary Completion
May 15, 2023
Study Completion
May 15, 2023
Last Updated
June 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share