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This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Other | Pragmatic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital ACT | Device | This is a virtual, single-arm, non-significant risk study. Study participants will receive 9 months of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the response rate to 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 | 9 months |
| 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. | Enrollment to Month 9 |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score |
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Inclusion Criteria:
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 | 94111 | 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 study.
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia
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FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms. |
| Enrollment to Month 9 |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score | FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function. | Enrollment to Month 9 |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score | FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact. | Enrollment to Month 9 |
| Participant's self-reported average weekly pain score, recorded on an NRS scale | Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity. | Enrollment to Month 9 |
| Participant's self-reported average weekly pain interference score, recorded on an NRS | Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference. | Enrollment to Month 9 |
| Participant's self-reported weekly sleep interference score, recorded on an NRS scale | Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference. | Enrollment to Month 9 |
| D009422 |
| Nervous System Diseases |