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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Digital ACT

• 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

Arm && Interventions

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

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