"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia (REACT-FM)

The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 130
• 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: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Participant is 22 years of age or older
2. Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
3. Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).

Key Exclusion Criteria:

1. Participant is not a resident of the United States
2. In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
3. Participant has a diagnosis of, or is being treated for any type of Dementia (Parkinson's disease, Alzheimer's Disease, Huntington's Disease, Lewy Body Dementia, Creuztfeldt-Jacob Disease, Frontotemporal Dementia, Korsakoff Syndrome, Vascular Dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)

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; Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC) Response	PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse	Week 12

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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
Participant's self-reported average weekly pain interference score, recorded on an NRS scale	Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.	Baseline to Week 12
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.	Baseline to Week 12
Participant's engagement with the Digital ACT device	Participant engagement will be assessed by evaluating the following: Average days engaged in treatment per week (number of days opening the device), with a higher score indicating more engagement.	Weeks 1-12
Participant's engagement with the Digital ACT device	Participant engagement will be assessed by evaluating the following: Average number of completed sessions per week, with a higher score indicating more engagement.	Weeks 1-12
Participant's compliance with the Digital ACT device	Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.	Weeks 1-12

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): July 25, 2021
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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