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

Swing Therapeutics

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Digital ACT

Study type: Interventional

Funder types: Other

Identifiers

NCT05433337

Swing-005-EXT

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Digital Acceptance and Commitment Therapy (ACT) Arm

Other group

Treatment:

Device: Digital ACT