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

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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:
Information provided by (Responsible Party):
Swing Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 10, 2021
First Posted Date  ICMJE August 13, 2021
Results First Submitted Date  ICMJE July 12, 2023
Results First Posted Date  ICMJE August 1, 2023
Last Update Posted Date August 1, 2023
Actual Study Start Date  ICMJE October 28, 2020
Actual Primary Completion Date July 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Official Title  ICMJE "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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2021)
67
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2021)
70
Actual Study Completion Date  ICMJE July 9, 2021
Actual Primary Completion Date July 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05005351
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Swing Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Swing Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Gendreau, MD Consulting Chief Medical Officer
PRS Account Swing Therapeutics, Inc.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP