Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

"PROSPER-FM-EXT": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

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.

Key Inclusion Criteria:

• 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 Criteria:

• 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