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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Active Comparator |
| |
| Digital Symptom Tracker | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital ACT | Device | Participants in this arm receive Digital ACT as well as standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) response rate | Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gendreau, MD | Consulting Chief Medical Officer | Study Chair |
| Lesley Arnold, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #37 | Covina | California | 91722 | United States | ||
| Site #15 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38991582 | Derived | 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. |
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| Digital Symptom Tracker | Other | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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