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

Fibromyalgia Clinical Trial

— REACT-FM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05011162
• Other study ID #: Swing-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Swing Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Digital ACT
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).

Locations

Country	Name	City	State
United States	Swing Therapeutics	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Swing Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 12
Secondary	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	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Weeks 1-12
Secondary	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.	Weeks 1-12
Secondary	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.	Weeks 1-12

External Links

•   Swing Therapeutics Website