FibromyalgiaNCT05773482
Effects of Breathing and Attention Training (BAT) on Pain Modulation
A study testing Breathing and Attention Training (BAT) in people with Fibromyalgia, run by University of Florida at 1 site in United States.
Trial summary
The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Breathing and Attention Training (BAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 9 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)
- Healthy, pain-free age matched controls without chronic pain
Who cannot join
- Personal or family history of photosensitive epilepsy
- Prior history of cancer or diabetes
- Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roland Staud, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Melyssa Godfrey, 352-265-8901, Melyssa.Godfrey@medicine.ufl.edu
Roland Staud, MD
About this study
Official title: Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain
The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.
- Conditions
- Fibromyalgia
- Being tested
- Breathing and Attention Training (BAT), Breathing Control
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing and Attention Training (BAT)Behavioural
BAT is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session.
Breathing ControlBehavioural
Controlled Breathing (without mindfulness) is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session.
| Study group | Role | What they receive |
|---|---|---|
| Breathing and Attention Training (BAT) | Experimental | Participants will be asked to do 20-minutes of focused breathing and attention training, involving focusing on taking deep breaths and becoming aware of the changing body sensations associated with breathing (mindfulness). Receives: Behavioral: Breathing and Attention Training (BAT) |
| Controlled Deep Breathing | Active comparator | Participants will be asked to do 20-minutes of deep breathing and letting the body relax. Receives: Behavioral: Breathing Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of Painful and Painless Sensory Stimuli
Ratings of painful and non-painful stimuli in FM subjects and HC will be obtained before and after BAT or Deep Breathing. Painful stimuli will include pressure stimuli. Painless stimuli will consist of flashing light stimuli.
Measured: 2 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start3 Apr 2023
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2028 (estimated)
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This parallel study will be age \& sex matched, and randomized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Staud, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773482
- Sponsor's protocol ID
- IRB202300172
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05773482
- Acronym / sponsor ID
- IRB202300172
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Mar 2028 (estimated)
- First posted
- 17 Mar 2023 (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 hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This parallel study will be age \& sex matched, and randomized.
| Arm | Type | Receives |
|---|---|---|
| Breathing and Attention Training (BAT) | Experimental | Behavioral: Breathing and Attention Training (BAT)Participants will be asked to do 20-minutes of focused breathing and attention training, involving focusing on taking deep breaths and becoming aware of the changing body sensations associated with breathing (mindfulness). |
| Controlled Deep Breathing | Active comparator | Behavioral: Breathing ControlParticipants will be asked to do 20-minutes of deep breathing and letting the body relax. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)
- Healthy, pain-free age matched controls without chronic pain
Key exclusion criteria (3 listed)
- Personal or family history of photosensitive epilepsy
- Prior history of cancer or diabetes
- Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.
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 |
|---|---|---|
| Breathing and Attention Training (BAT)BAT is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session. | Behavioural | Breathing and Attention Training (BAT) |
| Breathing ControlControlled Breathing (without mindfulness) is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session. | Behavioural | Controlled Deep Breathing |
Primary outcome
Ratings of Painful and Painless Sensory Stimuli
Time frame: 2 hr
Ratings of painful and non-painful stimuli in FM subjects and HC will be obtained before and after BAT or Deep Breathing. Painful stimuli will include pressure stimuli. Painless stimuli will consist of flashing light stimuli.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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.
Roland Staud, MD contact
Roland Staud, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing and Attention Training (BAT) in people with Fibromyalgia, run by University of Florida 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melyssa Godfrey (352-265-8901, painresearch@medicine.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratings of Painful and Painless Sensory Stimuli (time frame: 2 hr). 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 6 Jul 2026.