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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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:
1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
2. Symptoms have been present at a similar level for at least 3 months;
3. 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.

Arm && Interventions

Group	Intervention	Description
Digital Symptom Tracker	Digital Symptom Tracker	-
Digital Acceptance and Commitment Therapy (ACT)	Digital ACT	-

Primary Outcome Measures

Name	Time	Method
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

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

Locations (7): University of Cincinnati Physicians Company, LLC
🇺🇸
Cincinnati, Ohio, United States
Upstate Clinical Research Associates LLC
🇺🇸
Williamsville, New York, United States
Excell Research, Inc.
🇺🇸
Oceanside, California, United States
Superior Research LLC
🇺🇸
Sacramento, California, United States
Lehigh Center for Clinical Research
🇺🇸
Allentown, Pennsylvania, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸
North Canton, Ohio, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States