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

Primary Purpose

Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital ACT
Sponsored by
Swing Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Swing Therapeutics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Digital Acceptance and Commitment Therapy (ACT) Arm

Arm Description

Pragmatic

Outcomes

Primary Outcome Measures

Patient Global Impression of Change (PGIC) Response
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Secondary Outcome Measures

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.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score
FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score
FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score
FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.
Participant's self-reported average weekly pain score, recorded on an NRS scale
Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.
Participant's self-reported average weekly pain interference score, recorded on an NRS scale
Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.
Participant's self-reported weekly sleep interference score, recorded on an NRS scale
Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.
Participant's engagement with the Digital ACT device
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.
Participant's engagement with the Digital ACT device
Participant engagement will be assessed by evaluating the following: Average number of completed sessions per week, with a higher score indicating more engagement.
Participant's compliance with the Digital ACT device
Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.

Full Information

First Posted
August 10, 2021
Last Updated
August 30, 2023
Sponsor
Swing Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05011162
Brief Title
"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
Acronym
REACT-FM
Official Title
"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swing Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Acceptance and Commitment Therapy (ACT) Arm
Arm Type
Other
Arm Description
Pragmatic
Intervention Type
Device
Intervention Name(s)
Digital ACT
Intervention Description
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).
Primary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC) Response
Description
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Description
FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
Time Frame
Baseline to Week 12
Title
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score
Description
FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.
Time Frame
Baseline to Week 12
Title
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score
Description
FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.
Time Frame
Baseline to Week 12
Title
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score
Description
FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.
Time Frame
Baseline to Week 12
Title
Participant's self-reported average weekly pain score, recorded on an NRS scale
Description
Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.
Time Frame
Baseline to Week 12
Title
Participant's self-reported average weekly pain interference score, recorded on an NRS scale
Description
Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.
Time Frame
Baseline to Week 12
Title
Participant's self-reported weekly sleep interference score, recorded on an NRS scale
Description
Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.
Time Frame
Baseline to Week 12
Title
Participant's engagement with the Digital ACT device
Description
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.
Time Frame
Weeks 1-12
Title
Participant's engagement with the Digital ACT device
Description
Participant engagement will be assessed by evaluating the following: Average number of completed sessions per week, with a higher score indicating more engagement.
Time Frame
Weeks 1-12
Title
Participant's compliance with the Digital ACT device
Description
Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.
Time Frame
Weeks 1-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participant is 22 years of age or older Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically). Key Exclusion Criteria: Participant is not a resident of the United States In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Keefe, MD
Organizational Affiliation
Swing Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swing Therapeutics
City
San Francisco
State/Province
California
ZIP/Postal Code
94111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.swingtherapeutics.com/
Description
Swing Therapeutics Website

Learn more about this trial

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

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