Trial Outcomes & Findings for "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia (NCT NCT05005351)
NCT ID: NCT05005351
Last Updated: 2023-08-01
Results Overview
FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Digital Acceptance and Commitment Therapy (ACT) Arm
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
28
|
|
Overall Study
COMPLETED
|
37
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Baseline characteristics by cohort
| Measure |
Digital Acceptance and Commitment Therapy (ACT)
n=39 Participants
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
|
Digital Symptom Tracker Arm
n=28 Participants
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.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
53.6 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
52.8 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
Outcome measures
| Measure |
Digital Acceptance and Commitment Therapy (ACT) Arm
n=39 Participants
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
|
Digital Symptom Tracker Arm
n=28 Participants
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.
|
|---|---|---|
|
Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score
|
-8.7 score on a scale
Standard Error 2.0
|
-3.0 score on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Week 12PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Outcome measures
| Measure |
Digital Acceptance and Commitment Therapy (ACT) Arm
n=37 Participants
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
|
Digital Symptom Tracker Arm
n=27 Participants
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.
|
|---|---|---|
|
Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement
|
27 Participants
|
6 Participants
|
Adverse Events
Digital Acceptance and Commitment Therapy (ACT) Arm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Digital Symptom Tracker Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digital Acceptance and Commitment Therapy (ACT) Arm
n=39 participants at risk
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
|
Digital Symptom Tracker Arm
n=28 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/39 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
|
Infections and infestations
Sinus infection
|
0.00%
0/39 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/39 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
|
Infections and infestations
Cellulitis in Face
|
0.00%
0/39 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
|
Infections and infestations
Post COVID-19 Vaccination Syndrome
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Fever
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Injury, poisoning and procedural complications
Broken Foot
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Blood and lymphatic system disorders
Worsening Anemia
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Gastrointestinal disorders
Exacerbation of Gastroparesis
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of Fibromyalgia Pain
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Injury, poisoning and procedural complications
Left Side Rib Contusions
|
2.6%
1/39 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place