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

NCT05011162 | Completed FDA Device

• 1 other identifier: Swing-003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  Baseline to Week 12

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

  Baseline to Week 12

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

Study Arms (1)

Digital Acceptance and Commitment Therapy (ACT) Arm

OTHER

Pragmatic

Device: Digital ACT

Interventions

Digital ACT DEVICE

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

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 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).

You may not qualify if:

• 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)

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: August 10, 2021
• First Posted: August 18, 2021
• Study Start: July 25, 2021
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)