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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05005351
Other study ID # Swing-004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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