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This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital ACT | Device | Study participants will continue to receive Digital Acceptance and Commitment Therapy in addition to their standard care for fibromyalgia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score | FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity. | Original Study Baseline to Month 9 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Keefe, MD | Swing Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swing Therapeutics | San Francisco | California | 94104 | United States |
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| Label | URL |
|---|---|
| Swing Therapeutics Website | View source |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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This is a virtual, single-arm, pragmatic, non-significant risk device study. Study participants will continue to have access to Digital Acceptance and Commitment Therapy (ACT) after the original 12-week study (PROSPER-FM, NCT05243511), in addition to their standard care for fibromyalgia
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| D009422 |
| Nervous System Diseases |