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The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.
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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 | Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) Response | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | Week 12 |
| 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. | Baseline to Week 12 |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score |
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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 | 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 impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact. |
| Baseline to Week 12 |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score | FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms. | Baseline to Week 12 |
| 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. | Baseline to Week 12 |
| 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. | Baseline to Week 12 |
| Participant's self-reported average weekly pain interference score, recorded on an NRS scale | Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference. | Baseline to Week 12 |
| 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. | Baseline to Week 12 |
| Participant's engagement with the Digital ACT device | Participant engagement will be assessed by evaluating the following: Average days engaged in treatment per week (number of days opening the device), with a higher score indicating more engagement. | Weeks 1-12 |
| Participant's engagement with the Digital ACT device | Participant engagement will be assessed by evaluating the following: Average number of completed sessions per week, with a higher score indicating more engagement. | Weeks 1-12 |
| Participant's compliance with the Digital ACT device | Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame. | Weeks 1-12 |
| D009422 |
| Nervous System Diseases |