SMART-FM: Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia

Study Overview
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Brief Summary
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This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.

Official Title
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SMART-FM: Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Digital ACT
* Device: Digital Symptom Tracker


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject is 22 to 75 years of age, inclusive Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria: Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9; Symptoms have been present at a similar level for at least 3 months; Pain must be present in at least 4 out of 5 body regions Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. Subject is capable of reading and understanding English and has provided written informed consent to participate. Key Exclusion Criteria: Lifetime history of bipolar disorder as assessed by the MINI. Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI. Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment. The subject is at increased risk of suicide on the basis of the investigator's judgment, a response > 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale (C-SSRS) conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year). Subject has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the subject, interfere with the evaluation of the study device's efficacy or safety, or compromise the subject's ability to comply with/complete the study.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digital Acceptance and Commitment Therapy (ACT)<br> | Device: Digital ACT<br>* Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.<br>|
| Active Comparator: Digital Symptom Tracker<br> | Device: Digital Symptom Tracker<br>* Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.<br>|

What is the study measuring?
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Primary 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | Week 12 |