Status:
COMPLETED
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study
Lead Sponsor:
Swing Therapeutics, Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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 trea...
Eligibility Criteria
Inclusion
- Key
- Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
- Participant is willing and able to comply with all protocol-specified requirements
- Key
Exclusion
- Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
- Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
- Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05433337
Start Date
June 8 2022
End Date
March 5 2024
Last Update
June 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Swing Therapeutics
San Francisco, California, United States, 94104