Fibromyalgia
Conditions
Brief summary
This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.
Interventions
DEVICEDigital ACT
This is a virtual, single-arm, non-significant risk study. Study participants will receive 9 months of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia.
Sponsors
Swing Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has completed participation in the REACT-FM study. * Participant has completed 41 sessions within Tempo in the REACT-FM study and is willing and able to comply with all protocol-specified requirements. * Participant has provided informed consent to participate. * Participant continues to meet original safety criteria for the REACT-FM study.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC). | 9 months | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score | Enrollment to Month 9 | 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 | Enrollment to Month 9 | FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function. |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score | Enrollment to Month 9 | FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact. |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score | Enrollment to Month 9 | FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity. |
| Participant's self-reported average weekly pain interference score, recorded on an NRS | Enrollment to Month 9 | 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 | Enrollment to Month 9 | Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference. |
| Participant's self-reported average weekly pain score, recorded on an NRS scale | Enrollment to Month 9 | Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity. |
Countries
United States
Outcome results
None listed