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

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT05149222
• Lead Sponsor: Swing Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-24
• Study Start: 2021-11-30
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-08
• Primary Completion: 2024-04-14
• Study Completion: 2024-04-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC).	9 months	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	Enrollment to Month 9	FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
Participant's self-reported weekly sleep interference score, recorded on an NRS scale	Enrollment to Month 9	Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.
Participant's self-reported average weekly pain interference score, recorded on an NRS	Enrollment to Month 9	Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.
Participant's self-reported average weekly pain score, recorded on an NRS scale	Enrollment to Month 9	Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score	Enrollment to Month 9	FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score	Enrollment to Month 9	FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score	Enrollment to Month 9	FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.

Trial Locations

Locations (1)

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