Clinical trial NCT05005351: "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Official title: "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: Swing Therapeutics, Inc.
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 67
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement
timeFrame: Week 12
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Sacramento
country: United States
facility: Superior Research LLC
state: California
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates LLC
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company, LLC
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: Consulting Chief Medical Officer
name: Michael Gendreau, MD
role: STUDY_DIRECTOR
References:
citation: Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.