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"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia (REACT-FM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05011162
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Swing Therapeutics, Inc.

Brief Summary:
The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Digital ACT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a virtual, single-arm, pragmatic, non-significant risk study.

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
Actual Study Start Date : July 25, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Digital Acceptance and Commitment Therapy (ACT) Arm
Pragmatic
Device: Digital ACT
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).




Primary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) Response [ Time Frame: Week 12 ]
    PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse


Secondary Outcome Measures :
  1. 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.

  2. Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score [ Time Frame: Baseline to Week 12 ]
    FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.

  3. Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score [ Time Frame: Baseline to Week 12 ]
    FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.

  4. Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score [ Time Frame: Baseline to Week 12 ]
    FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.

  5. Participant's self-reported average weekly pain score, recorded on an NRS scale [ Time Frame: Baseline to Week 12 ]
    Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.

  6. Participant's self-reported average weekly pain interference score, recorded on an NRS scale [ Time Frame: Baseline to Week 12 ]
    Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.

  7. Participant's self-reported weekly sleep interference score, recorded on an NRS scale [ Time Frame: Baseline to Week 12 ]
    Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.

  8. Participant's engagement with the Digital ACT device [ Time Frame: Weeks 1-12 ]

    Participant engagement will be assessed by evaluating the following:

    Average days engaged in treatment per week (number of days opening the device), with a higher score indicating more engagement.


  9. Participant's engagement with the Digital ACT device [ Time Frame: Weeks 1-12 ]

    Participant engagement will be assessed by evaluating the following:

    Average number of completed sessions per week, with a higher score indicating more engagement.


  10. Participant's compliance with the Digital ACT device [ Time Frame: Weeks 1-12 ]
    Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Participant is 22 years of age or older
  2. Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
  3. Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).

Key Exclusion Criteria:

  1. Participant is not a resident of the United States
  2. In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
  3. Participant has a diagnosis of, or is being treated for any type of Dementia (Parkinson's disease, Alzheimer's Disease, Huntington's Disease, Lewy Body Dementia, Creuztfeldt-Jacob Disease, Frontotemporal Dementia, Korsakoff Syndrome, Vascular Dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011162


Contacts
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Contact: Jeremy Frank, PhD 619-332-0553 jeremy@swingtherapeutics.com
Contact: Nicolette Vega 619-332-0553 nicolette@swingtherapeutics.com

Locations
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United States, California
Swing Therapeutics Recruiting
San Francisco, California, United States, 94111
Contact: Savannah Hamilton    619-332-0553    savannah@swingtherapeutics.com   
Principal Investigator: Brian Keefe, MD         
Sponsors and Collaborators
Swing Therapeutics, Inc.
Investigators
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Principal Investigator: Brian Keefe, MD Swing Therapeutics
Additional Information:
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Responsible Party: Swing Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05011162    
Other Study ID Numbers: Swing-003
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases