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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).
Swing Therapeutics
San Francisco, California, United States
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
Time frame: Week 12
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.
Time frame: Baseline to Week 12
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.
Time frame: Baseline to Week 12
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.
Time frame: Baseline to Week 12
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.
Time frame: Baseline to Week 12
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.
Time frame: Baseline to Week 12
Participant's self-reported average weekly pain interference score, recorded on an NRS scale
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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
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.
Time frame: Baseline to Week 12
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.
Time frame: Weeks 1-12
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.
Time frame: Weeks 1-12
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.
Time frame: Weeks 1-12