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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Digital ACT; Device: Digital Symptom Tracker

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Sacramento, California, United States, 95831
      • Superior Research LLC
  • Florida
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
  • New York
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Physicians Company, LLC
    • North Canton, Ohio, United States, 44720
      • Neuro-Behavioral Clinical Research, Inc.
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital Symptom Tracker	Device: 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.
Active Comparator: Digital Acceptance and Commitment Therapy (ACT)	Device: Digital ACT; Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swing Therapeutics, Inc.
• Investigators: Study Director: Michael Gendreau, MD, Consulting Chief Medical Officer

Publications and helpful links

General Publications

• 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. 2023 Jun 29. doi: 10.1007/s10865-023-00429-3. Online ahead of print.

Helpful Links

• Swing Therapeutics Website

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): July 9, 2021

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Swing-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No