"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Digital ACT; Digital Symptom Tracker
Intervention description: Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 22 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subject is 22 to 75 years of age, inclusive

          2. 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

          3. Subject with ongoing treatments should be on stable therapy for 30 days prior to
             screening appointment.

          4. Subject is capable of reading and understanding English and has provided written
             informed consent to participate.

        Key Exclusion Criteria:

          1. Lifetime history of bipolar disorder as assessed by the MINI.

          2. Current, untreated, major depressive episode and/or anxiety disorders as assessed by
             the MINI.

          3. Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline
             appointment.

          4. 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).

          5. 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.