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

Swing Therapeutics, Inc.1 site in 1 country130 target enrollmentJuly 25, 2021

ConditionsFibromyalgia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Swing Therapeutics, Inc.
Enrollment: 130
Locations: 1
Primary Endpoint: Patient Global Impression of Change (PGIC) Response
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 25, 2021

End Date

March 5, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Swing Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Participant is not a resident of the United States
•In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
•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)

Outcomes

Primary Outcomes

Patient Global Impression of Change (PGIC) Response

Time Frame: Week 12

PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Secondary Outcomes

Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score(Baseline to Week 12)
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score(Baseline to Week 12)
Participant's engagement with the Digital ACT device(Weeks 1-12)
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score(Baseline to Week 12)
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score(Baseline to Week 12)
Participant's self-reported average weekly pain score, recorded on an NRS scale(Baseline to Week 12)
Participant's self-reported average weekly pain interference score, recorded on an NRS scale(Baseline to Week 12)
Participant's compliance with the Digital ACT device(Weeks 1-12)
Participant's self-reported weekly sleep interference score, recorded on an NRS scale(Baseline to Week 12)