Trials / Completed
CompletedNCT05005351
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Swing Therapeutics, Inc. · Academic / Other
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Digital ACT | Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. |
| DEVICE | Digital Symptom Tracker | Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. |
Timeline
- Start date
- 2020-10-28
- Primary completion
- 2021-07-09
- Completion
- 2021-07-09
- First posted
- 2021-08-13
- Last updated
- 2023-08-01
- Results posted
- 2023-08-01
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05005351. Inclusion in this directory is not an endorsement.