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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Digital ACT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Digital Acceptance and Commitment Therapy (ACT) Arm<br>Pragmatic | Device: Digital ACT<br>* Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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