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

Swing Therapeutics

Status

Completed

Conditions

Fibromyalgia

Treatments

Device: Digital ACT

Study type

Interventional

Funder types

Other

Identifiers

NCT05011162

Swing-003

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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).

Key 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)