"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Study Details
Study Description
Brief Summary
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of three 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Digital Acceptance and Commitment Therapy (ACT) Arm 1
|
Device: Digital ACT 1
Participants in Digital ACT Group 1 complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
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| Active Comparator: Digital Acceptance and Commitment Therapy (ACT) Arm 2
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Device: Digital ACT 2
Participants in Digital ACT Group 2 complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
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| Active Comparator: Digital Symptom Tracker Arm
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Other: Digital Symptom Tracker
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.
|
Outcome Measures
Primary Outcome Measures
- Mean change from baseline to Week 12 in the weekly 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.
Secondary Outcome Measures
- Subject's self-reported Global Impression of Change (PGIC) [Weeks 4, 8 and 12]
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
- 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) function domain score [Baseline to Week 12]
FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.
- 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.
- Subject's self-reported average pain intensity score, recorded as an NRS score weekly [Baseline to Week 12]
Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.
- Subject's self-reported average pain interference score, recorded as an NRS score weekly [Baseline to Week 12]
Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.
- Subject'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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Subject is 22 to 75 years of age, inclusive
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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:
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Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
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Symptoms have been present at a similar level for at least 3 months;
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Pain must be present in at least 4 out of 5 body regions
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Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
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Subject is capable of reading and understanding English and has provided written informed consent to participate.
Key Exclusion Criteria:
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Lifetime history of bipolar disorder as assessed by the MINI.
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Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
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Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment.
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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).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site #15 | Oceanside | California | United States | 92056 |
| 2 | Site #11 | Sacramento | California | United States | 95831 |
| 3 | Site #13 | Orlando | Florida | United States | 32801 |
| 4 | Site #12 | Williamsville | New York | United States | 14221 |
| 5 | Site #14 | Cincinnati | Ohio | United States | 45219 |
| 6 | Site #10 | North Canton | Ohio | United States | 44720 |
| 7 | Site #16 | Allentown | Pennsylvania | United States | 18104 |
Sponsors and Collaborators
- Swing Therapeutics, Inc.
Investigators
- Study Chair: Michael Gendreau, MD, Consulting Chief Medical Officer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Swing-004