Fibromyalgia
Conditions
Brief summary
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.
Interventions
DEVICEDigital ACT
Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
DEVICEDigital Symptom Tracker
Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.
Sponsors
Swing Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Subject is 22 to 75 years of age, inclusive 2. Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria: 1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9; 2. Symptoms have been present at a similar level for at least 3 months; 3. Pain must be present in at least 4 out of 5 body regions 3. Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. 4. Subject is capable of reading and understanding English and has provided written informed consent to participate. Key
Exclusion criteria
1. Lifetime history of bipolar disorder as assessed by the MINI. 2. Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI. 3. Subject has a BDI-II total score \> 25 at either the Screening appointment or Baseline appointment. 4. The subject is at increased risk of suicide on the basis of the investigator's judgment, a response \> 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale (C-SSRS) conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year). 5. Subject has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the subject, interfere with the evaluation of the study device's efficacy or safety, or compromise the subject's ability to comply with/complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement | Week 12 | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. | 39 |
| Digital Symptom Tracker Arm Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. | 28 |
| Total | 67 |
Baseline characteristics
| Characteristic | Digital Acceptance and Commitment Therapy (ACT) | Digital Symptom Tracker Arm | Total |
|---|---|---|---|
| Age, Continuous | 52.2 Years STANDARD_DEVIATION 10.5 | 53.6 Years STANDARD_DEVIATION 10.1 | 52.8 Years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 24 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 28 Participants | 66 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 28 |
| other Total, other adverse events | 7 / 39 | 3 / 28 |
| serious Total, serious adverse events | 0 / 39 | 0 / 28 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score | -8.7 score on a scale | Standard Error 2 |
| Digital Symptom Tracker Arm | Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score | -3.0 score on a scale | Standard Error 2.4 |
Secondary
Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement | 27 Participants |
| Digital Symptom Tracker Arm | Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement | 6 Participants |