"REACT-FM-EXT": Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia: An Extension Study

This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Digital ACT

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94111
      • Swing Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has completed participation in the REACT-FM study.
• Participant has completed 41 sessions within Tempo in the REACT-FM study and is willing and able to comply with all protocol-specified requirements.
• Participant has provided informed consent to participate.
• Participant continues to meet original safety criteria for the REACT-FM study.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Digital Acceptance and Commitment Therapy (ACT) Arm; Pragmatic	Device: Digital ACT; This is a virtual, single-arm, non-significant risk study. Study participants will receive 9 months of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary efficacy endpoint is the response rate to 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	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score	FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.	Enrollment to Month 9
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score	FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.	Enrollment to Month 9
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score	FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.	Enrollment to Month 9
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score	FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.	Enrollment to Month 9
Participant's self-reported average weekly pain score, recorded on an NRS scale	Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.	Enrollment to Month 9
Participant's self-reported average weekly pain interference score, recorded on an NRS	Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.	Enrollment to Month 9
Participant's self-reported weekly sleep interference score, recorded on an NRS scale	Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.	Enrollment to Month 9

Collaborators and Investigators

• Sponsor: Swing Therapeutics, Inc.
• Investigators: Principal Investigator: Brian Keefe, MD, Swing Therapeutics

Publications and helpful links

Helpful Links

• Swing Therapeutics Website

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): April 14, 2024
• Study Completion (Actual): April 14, 2024

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Swing-003-EXT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No