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

• ClinicalTrials.gov Identifier: NCT05005351
• Recruitment Status: Completed
• First Posted: August 13, 2021
• Results First Posted: August 1, 2023
• Last Update Posted: August 1, 2023
• Sponsor: Swing Therapeutics, Inc.
• Information provided by (Responsible Party): Swing Therapeutics, Inc.

Tracking Information

• First Submitted Date: August 10, 2021
• First Posted Date: August 13, 2021
• Results First Submitted Date: July 12, 2023
• Results First Posted Date: August 1, 2023
• Last Update Posted Date: August 1, 2023
• Actual Study Start Date: October 28, 2020
• Actual Primary Completion Date: July 9, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 12, 2023)

Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score [ Time Frame: Baseline to Week 12 ]

FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.

• Original Primary Outcome Measures (submitted: August 10, 2021): Mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score. [ Time Frame: Baseline to Week 12 ]

Current Secondary Outcome Measures (submitted: July 12, 2023)

Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement [ Time Frame: Week 12 ]

PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Original Secondary Outcome Measures (submitted: August 10, 2021)

• Subject's self-reported Global Impression of Change (PGIC) [ Time Frame: Weeks 4, 8 and 12 ]
• Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score [ Time Frame: Baseline to Week 12 ]
• Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score [ Time Frame: Baseline to Week 12 ]
• Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score [ Time Frame: Baseline to Week 12 ]
• Subject's self-reported average pain intensity score, recorded as an NRS score weekly [ Time Frame: Baseline to Week 12 ]
• Subject's self-reported average pain interference score, recorded as an NRS score weekly [ Time Frame: Baseline to Week 12 ]
• Subject's self-reported weekly sleep interference score, recorded on an NRS scale [ Time Frame: Baseline to Week 12 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
• Official Title: "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fibromyalgia

Intervention

• Device: Digital ACT
  Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
• 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.

Study Arms

• Active Comparator: Digital Acceptance and Commitment Therapy (ACT)
  Intervention: Device: Digital ACT
• Active Comparator: Digital Symptom Tracker
  Intervention: Device: Digital Symptom Tracker

• 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. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 15, 2021): 67
• Original Estimated Enrollment (submitted: August 10, 2021): 70
• Actual Study Completion Date: July 9, 2021
• Actual Primary Completion Date: July 9, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05005351
• Other Study ID Numbers: Swing-004
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Swing Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Swing Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Michael Gendreau, MD; Consulting Chief Medical Officer

• PRS Account: Swing Therapeutics, Inc.
• Verification Date: February 2022