FibromyalgiaPhase 2SMART-FMNCT05005351
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
A Phase 2 study testing Digital ACT and Digital Symptom Tracker in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Digital ACT and Digital Symptom Tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Oct 2020to 9 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 22 to 75 years of age, inclusive
- 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:
- Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
- Symptoms have been present at a similar level for at least 3 months;
- Pain must be present in at least 4 out of 5 body regions
- Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
- Subject is capable of reading and understanding English and has provided written informed consent to participate.
Who cannot join
- Lifetime history of bipolar disorder as assessed by the MINI.
- Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
- Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment.
- 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).
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, 45219
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720
Excell Research, Inc.
Oceanside, California, 92056
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Superior Research LLC
Sacramento, California, 95831
Upstate Clinical Research Associates LLC
Williamsville, New York, 14221
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Digital ACT, Digital Symptom Tracker
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital ACTDevice
Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
Digital Symptom TrackerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) | Active comparator | Not described Receives: Device: Digital ACT |
| Digital Symptom Tracker | Active comparator | Not described Receives: Device: Digital Symptom Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (1)
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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start28 Oct 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swing Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Gendreau, MD, Study director, Consulting Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005351
- Sponsor's protocol ID
- Swing-004
- Acronym
- SMART-FM
- Status last verified
- Feb 2022
- First submitted
- 10 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.
PubMed 37382794
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
- ClinicalTrials.gov ID
- NCT05005351
- Acronym / sponsor ID
- SMART-FM / Swing-004
- Conditions
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Swing Therapeutics, Inc.University, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) | Active comparator | Device: Digital ACT |
| Digital Symptom Tracker | Active comparator | Device: Digital Symptom Tracker |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 22 to 75 years of age, inclusive
- 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:
- Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
- Subject is capable of reading and understanding English and has provided written informed consent to participate.
Key exclusion criteria (5 listed)
- Lifetime history of bipolar disorder as assessed by the MINI.
- Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
- Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital ACTParticipants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. | Device | Digital Acceptance and Commitment Therapy (ACT) |
| Digital Symptom TrackerParticipants 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. | Device | Digital Symptom Tracker |
Primary outcome
Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score
Time frame: Baseline to Week 12
FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
1 secondary outcome
Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37382794Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.
- Swing Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gendreau, MD study director
Consulting Chief Medical Officer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Digital ACT and Digital Symptom Tracker in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.