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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Digital ACT

• Registration Number: NCT05011162
• Lead Sponsor: Swing Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-25
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-18
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Acceptance and Commitment Therapy (ACT) Arm	Digital ACT	Pragmatic

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score	Baseline to Week 12	FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score	Baseline to Week 12	FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.
Participant's engagement with the Digital ACT device	Weeks 1-12	Participant engagement will be assessed by evaluating the following: Average number of completed sessions per week, with a higher score indicating more engagement.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score	Baseline to Week 12	FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score	Baseline to Week 12	FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.
Participant's self-reported average weekly pain score, recorded on an NRS scale	Baseline to Week 12	Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.
Participant's self-reported average weekly pain interference score, recorded on an NRS scale	Baseline to Week 12	Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.
Participant's compliance with the Digital ACT device	Weeks 1-12	Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.
Participant's self-reported weekly sleep interference score, recorded on an NRS scale	Baseline to Week 12	Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.

Trial Locations

Locations (1)

Swing Therapeutics; 🇺🇸 San Francisco, California, United States