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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Digital ACT

• Registration Number: NCT05433337
• Lead Sponsor: Swing Therapeutics, Inc.

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 treatment of fibromyalgia.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-08
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-27
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Acceptance and Commitment Therapy (ACT) Arm	Digital ACT	-

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)	Month 9	PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Secondary Outcome Measures

Name	Time	Method
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score	Original Study Baseline to Month 9	FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.

Trial Locations

Locations (1)

Swing Therapeutics; 🇺🇸 San Francisco, California, United States