FibromyalgiaPROSPER-FM-EXTNCT05433337
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study
A study testing Digital ACT in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
- Participant is willing and able to comply with all protocol-specified requirements
Who cannot join
- Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
- Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
- Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "PROSPER-FM-EXT": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study
This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.
- 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 continue to receive Digital Acceptance and Commitment Therapy in addition to their standard care for fibromyalgia
| Study group | Role | What they receive |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Other | Not described 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)
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Measured: Month 9
Secondary outcomes (1)
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: Original Study Baseline to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start8 Jun 2022
- 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 device study. Study participants will continue to have access to Digital Acceptance and Commitment Therapy (ACT) after the original 12-week study (PROSPER-FM, NCT05243511), in addition to their standard care for fibromyalgia
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT05433337
- Sponsor's protocol ID
- Swing-005-EXT
- Acronym
- PROSPER-FM-EXT
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- "PROSPER-FM-EXT": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study
- ClinicalTrials.gov ID
- NCT05433337
- Acronym / sponsor ID
- PROSPER-FM-EXT / Swing-005-EXT
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Swing Therapeutics, Inc.University, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 27 Jun 2022 (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.
This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.
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 device study. Study participants will continue to have access to Digital Acceptance and Commitment Therapy (ACT) after the original 12-week study (PROSPER-FM, NCT05243511), in addition to their standard care for fibromyalgia
| Arm | Type | Receives |
|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) Arm | Other | Device: Digital ACT |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
- Participant is willing and able to comply with all protocol-specified requirements
Key exclusion criteria (3 listed)
- Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
- Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
- Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM 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 ACTStudy participants will continue to receive Digital Acceptance and Commitment Therapy in addition to their standard care for fibromyalgia | Device | Digital Acceptance and Commitment Therapy (ACT) Arm |
Primary outcome
Patient Global Impression of Change (PGIC)
Time frame: Month 9
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
1 secondary outcome
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Time frame: Original Study Baseline to Month 9
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.
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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 2 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) (time frame: Month 9). 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.