Fibromyalgia
Conditions
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.
Interventions
DEVICEDigital ACT
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) Response | Week 12 | 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) impact domain score | Baseline to Week 12 | 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 | Baseline to Week 12 | 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 | Baseline to Week 12 | 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 | Baseline to Week 12 | Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity. |
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score | Baseline to Week 12 | FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity. |
| Participant's self-reported weekly sleep interference score, recorded on an NRS scale | Baseline to Week 12 | 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 | 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. |
| Participant's compliance with the Digital ACT device | Weeks 1-12 | Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame. |
| Participant's self-reported average weekly pain interference score, recorded on an NRS scale | Baseline to Week 12 | Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference. |
Countries
United States
Outcome results
None listed