FibromyalgiaREACT-FMNCT05011162
"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
A study testing Digital ACT in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Digital ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2021to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is 22 years of age or older
- Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
- Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).
Who cannot join
- Participant is not a resident of the United States
- In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Digital ACT
- 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
Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).
| Study group | Role | What they receive |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Other | Pragmatic Receives: Device: Digital ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change (PGIC) Response
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Measured: Week 12
Secondary outcomes (10)
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
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score
FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.
Measured: Baseline to Week 12
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score
FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.
Measured: Baseline to Week 12
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score
FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.
Measured: Baseline to Week 12
Participant's self-reported average weekly pain score, recorded on an NRS scale
Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.
Measured: Baseline to Week 12
Participant's self-reported average weekly pain interference score, recorded on an NRS scale
Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.
Measured: Baseline to Week 12
Participant's self-reported weekly sleep interference score, recorded on an NRS scale
Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.
Measured: Baseline to Week 12
Participant's engagement with the Digital ACT device
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.
Measured: Weeks 1-12
Participant's engagement with the Digital ACT device
Participant engagement will be assessed by evaluating the following:
Average number of completed sessions per week, with a higher score indicating more engagement.
Measured: Weeks 1-12
Participant's compliance with the Digital ACT device
Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start25 Jul 2021
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swing Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Keefe, MD, Principal investigator, Swing Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011162
- Sponsor's protocol ID
- Swing-003
- Acronym
- REACT-FM
- Status last verified
- Jun 2024
- First submitted
- 10 Aug 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
- ClinicalTrials.gov ID
- NCT05011162
- Acronym / sponsor ID
- REACT-FM / Swing-003
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Swing Therapeutics, Inc.University, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Other | Device: Digital ACTPragmatic |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is 22 years of age or older
- Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
- Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).
Key exclusion criteria (3 listed)
- Participant is not a resident of the United States
- In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
- 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)
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 ACTStudy participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT). | Device | Digital Acceptance and Commitment Therapy (ACT) Arm |
Primary outcome
Patient Global Impression of Change (PGIC) Response
Time frame: Week 12
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
10 secondary outcomes
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Time frame: Baseline to Week 12
Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score
Time frame: Baseline to Week 12
Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score
Time frame: Baseline to Week 12
Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score
Time frame: Baseline to Week 12
Participant's self-reported average weekly pain score, recorded on an NRS scale
Time frame: Baseline to Week 12
Participant's self-reported average weekly pain interference score, recorded on an NRS scale
Time frame: Baseline to Week 12
Participant's self-reported weekly sleep interference score, recorded on an NRS scale
Time frame: Baseline to Week 12
Participant's engagement with the Digital ACT device
Time frame: Weeks 1-12
Participant's engagement with the Digital ACT device
Time frame: Weeks 1-12
Participant's compliance with the Digital ACT device
Time frame: Weeks 1-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- 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.
Brian Keefe, MD principal investigator
Swing Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital ACT in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 1 site 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 3 inclusion and 3 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Global Impression of Change (PGIC) Response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.