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

NCT05433337 | Completed FDA Device

• 1 other identifier: Swing-005-EXT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change (PGIC)

  PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

  Month 9

Secondary Outcomes (1)

• Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

  Original Study Baseline to Month 9

Study Arms (1)

Digital Acceptance and Commitment Therapy (ACT) Arm

OTHER

Device: Digital ACT

Interventions

Digital ACT DEVICE

Study participants will continue to receive Digital Acceptance and Commitment Therapy in addition to their standard care for fibromyalgia

Digital Acceptance and Commitment Therapy (ACT) Arm

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swing Therapeutics, Inc.: lead

Study Sites (1)

Swing Therapeutics

San Francisco, California, 94104, United States

Location

Related Links

• Swing Therapeutics Website

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Brian Keefe, MD

  Swing Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a virtual, single-arm, pragmatic, non-significant risk device study. Study participants will continue to have access to Digital Acceptance and Commitment Therapy (ACT) after the original 12-week study (PROSPER-FM, NCT05243511), in addition to their standard care for fibromyalgia

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: June 8, 2022
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)