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

NCT05005351 | Completed Phase 2 Results FDA Device

• 1 other identifier: Swing-004
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 7

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Week 12

Study Arms (2)

Digital Acceptance and Commitment Therapy (ACT)

ACTIVE COMPARATOR

Device: Digital ACT

Digital Symptom Tracker

ACTIVE COMPARATOR

Device: Digital Symptom Tracker

Interventions

Digital ACT DEVICE

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

Digital Acceptance and Commitment Therapy (ACT)

Digital Symptom Tracker DEVICE

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.

Digital Symptom Tracker

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 22 to 75 years of age, inclusive
• 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:
• Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
• Symptoms have been present at a similar level for at least 3 months;
• Pain must be present in at least 4 out of 5 body regions
• Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
• Subject is capable of reading and understanding English and has provided written informed consent to participate.

You may not qualify if:

• Lifetime history of bipolar disorder as assessed by the MINI.
• Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
• Subject has a BDI-II total score \> 25 at either the Screening appointment or Baseline appointment.
• 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).
• 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.

Sponsors & Collaborators

• Swing Therapeutics, Inc.: lead

Study Sites (7)

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Superior Research LLC

Sacramento, California, 95831, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States

Location

University of Cincinnati Physicians Company, LLC

Cincinnati, Ohio, 45219, United States

Location

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Related Publications (1)

• 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.

  PMID: 37382794 RESULT

Related Links

• Swing Therapeutics Website

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Swing Therapeutics, Inc.

research@swingtherapeutics.com

1 (415) 662-0415

Study Officials

• Michael Gendreau, MD

  Consulting Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 13, 2021
• Study Start: October 28, 2020
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)