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

Fibromyalgia Clinical Trial

— SMART-FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005351
• Other study ID #: Swing-004
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2020
• Est. completion date: July 9, 2021

Study information

• Verified date: February 2022
• Source: Swing Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

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.
• 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.

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	University of Cincinnati Physicians Company, LLC	Cincinnati	Ohio
United States	Neuro-Behavioral Clinical Research, Inc.	North Canton	Ohio
United States	Excell Research, Inc.	Oceanside	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Superior Research LLC	Sacramento	California
United States	Upstate Clinical Research Associates LLC	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Swing Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Swing Therapeutics Website