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

NCT05149222 | Completed FDA Device

• 1 other identifier: Swing-003-EXT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Enrollment to Month 9

• Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score

  Enrollment to Month 9

• Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score

  Enrollment to Month 9

• Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score

  Enrollment to Month 9

• Participant's self-reported average weekly pain score, recorded on an NRS scale

  Enrollment to Month 9

Study Arms (1)

Digital Acceptance and Commitment Therapy (ACT) Arm

OTHER

Pragmatic

Device: Digital ACT

Interventions

Digital ACT DEVICE

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.

Digital Acceptance and Commitment Therapy (ACT) Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Swing Therapeutics, Inc.: lead

Study Sites (1)

Swing Therapeutics

San Francisco, California, 94111, 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 study. Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: November 30, 2021
• Primary Completion: April 14, 2024
• Study Completion: April 14, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)