Clinical trial NCT05011162: "REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
Official title: "REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Swing Therapeutics, Inc.
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 130
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Patient Global Impression of Change (PGIC) Response
timeFrame: Week 12
Secondary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
timeFrame: Baseline to Week 12
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score
timeFrame: Baseline to Week 12
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score
timeFrame: Baseline to Week 12
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score
timeFrame: Baseline to Week 12
measure: Participant's self-reported average weekly pain score, recorded on an NRS scale
timeFrame: Baseline to Week 12
measure: Participant's self-reported average weekly pain interference score, recorded on an NRS scale
timeFrame: Baseline to Week 12
measure: Participant's self-reported weekly sleep interference score, recorded on an NRS scale
timeFrame: Baseline to Week 12
measure: Participant's engagement with the Digital ACT device
timeFrame: Weeks 1-12
measure: Participant's engagement with the Digital ACT device
timeFrame: Weeks 1-12
measure: Participant's compliance with the Digital ACT device
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Swing Therapeutics
state: California
Study officials:
affiliation: Swing Therapeutics
name: Brian Keefe, MD
role: PRINCIPAL_INVESTIGATOR
References: