FibromyalgiaBPETNCT06208514
Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
A study testing Brief pain exposure therapy (BPET) in people with Fibromyalgia and Lupus Erythematosus, Systemic, run by University of Michigan at 1 site in United States.
Trial summary
This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM), Lupus, chronic pelvic pain, and chronic low back pain learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia, Lupus, chronic pelvic pain, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Lupus Erythematosus, Systemic, Chronic Pelvic Pain
- What is being tested?
- Brief pain exposure therapy (BPET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, write and speak English
- Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
- Fibromyalgia participants must have:
- Physician diagnosis of fibromyalgia
- OR: meet 2016 American College of Rheumatology (ACR) Criteria for FM: Widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9
- OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician.
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- Lupus participants must have:
- Physician diagnosis of systemic lupus erythematosus
- AND: Have pain self-reported in 4 out of 7 body regions in the GSS-brief body map
- AND: No change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease).
- Chronic Low Back Pain participants must have:
- Low Back Pain for at least half the days over the past 6 months
- Over the past 7 days, an average pain intensity of at least 4 out of 10
Who cannot join
- Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal cord injury, cancer)
- Currently receiving cognitive-behavioral therapy or other psychological therapies for pain
- Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.
- Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.
- Pregnant or breastfeeding
- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
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- Lupus group only: taking >10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications)
- Chronic Pelvic Pain group only: surgery for any chronic pelvic pain related condition in the past 6 months
- Chronic low back pain only: scheduled back surgery; leg pain that is greater than your back pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Beth Banner, 734-998-5837, eledward@med.umich.edu
John Sturgeon, PhD
About this study
This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM), Lupus, chronic pelvic pain, and chronic low back pain learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia, Lupus, chronic pelvic pain, and chronic low back pain (such as depression or anxiety).
Read the detailed description
This project was amended and approved by the University of Michigan Medical School Institutional Review Board. These changes include adding chronic pelvic pain and chronic low back pain participants on to the study.
- Conditions
- Fibromyalgia, Lupus Erythematosus, Systemic, Chronic Pelvic Pain, Chronic Low Back Pain (CLBP)
- Being tested
- Brief pain exposure therapy (BPET)
- Keywords
- Pain exposure therapy, Telehealth-based behavioral intervention
- Medical subject headings
- Fibromyalgia, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief pain exposure therapy (BPET)Behavioural
Participants will complete daily logs for 7-days pre-treatment baseline, along with 21 days during the intervention protocol (fibromyalgia participants only will complete the daily logs), and 7 for days post-treatment.
Brief Pain Exposure Therapy will be given for 3 weeks, 1.5 hours per week, telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, mindfulness meditation, and graded exposure techniques for improving tolerance of painful or feared activities. Participants will also be provided handouts and pre-recorded meditation and imagery scripts that participants can use to facilitate between-session practices. In addition, participants will complete surveys through-out the study.
| Study group | Role | What they receive |
|---|---|---|
| Brief pain exposure therapy (BPET) | Experimental | Not described Receives: Behavioral: Brief pain exposure therapy (BPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)
This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).
Measured: Day 1, Day 60
Secondary outcomes (9)
Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)
This is a 17-item survey that participants answer strongly disagree (1) to strongly agree (4).
Total scores are between 17-68 with a higher value indicating higher kinesiophobia.
Measured: Day 1, Day 60
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)
Four questions are included in the PROMIS for pain interference. Participants will answer from not at all (1) to very much (5). Scores range from 4-20 with a higher score indicating more interference.
Measured: Day 1, Day 60
Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)
This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).
Measured: Day 1, Day 210
Change in TSK from day 1 (T1) to day 210 (T8)
This is a 17-item survey that participants answer strongly disagree (1) to strongly agree (4).
Total scores are between 17-68 with a higher value indicating higher kinesiophobia.
Measured: Day 1, Day 210
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)
Four questions are included in the PROMIS for pain interference. Participants will answer from not at all (1) to very much (5). Scores range from 4-20 with a higher score indicating more interference.
Measured: Day 1, Day 210
Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)
This is a 10-item survey that participant will complete after final intervention. Questions are answered from strongly disagree (1), neither agree or disagree (4), to agree (7). Scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention).
Measured: Day 29
Feasibility based on the number of sessions attended
Higher number of sessions attended shows higher level of feasibility.
Measured: Day 29
Feasibility based on the number of in-session and between-session practices completed
Higher number of sessions and between-sessions completed shows higher level of feasibility.
Measured: Day 29
Feasibility based on open-ended feedback at the completion of the intervention
Participants will complete the open-ended feedback form that has 4 questions regarding the intervention and will be summarized.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start4 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (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 MichiganThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The enrollment numbers were increased to 125 (from 70) after the University of Michigan Medical School Institutional Review Board approved the amendment.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Sturgeon, University of Michigan
- Investigators
- John Sturgeon, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208514
- Sponsor's protocol ID
- HUM00238637
- Acronym
- BPET
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2023
- Last updated
- 11 May 2026
- Results posted
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
- ClinicalTrials.gov ID
- NCT06208514
- Acronym / sponsor ID
- BPET / HUM00238637
- Conditions
- Fibromyalgia, Lupus Erythematosus, Systemic, Chronic Pelvic Pain, Chronic Low Back Pain (CLBP)
- Keywords
- Pain exposure therapy, Telehealth-based behavioral intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jan 2024 (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 intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM), Lupus, chronic pelvic pain, and chronic low back pain learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia, Lupus, chronic pelvic pain, and chronic low back pain (such as depression or anxiety).
Detailed description
This project was amended and approved by the University of Michigan Medical School Institutional Review Board. These changes include adding chronic pelvic pain and chronic low back pain participants on to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The enrollment numbers were increased to 125 (from 70) after the University of Michigan Medical School Institutional Review Board approved the amendment.
| Arm | Type | Receives |
|---|---|---|
| Brief pain exposure therapy (BPET) | Experimental | Behavioral: Brief pain exposure therapy (BPET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to read, write and speak English
- Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
- Physician diagnosis of fibromyalgia
- OR: meet 2016 American College of Rheumatology (ACR) Criteria for FM: Widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9
- OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician.
Key exclusion criteria (9 listed)
- Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal cord injury, cancer)
- Currently receiving cognitive-behavioral therapy or other psychological therapies for pain
- Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.
- Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.
- Pregnant or breastfeeding
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 |
|---|---|---|
| Brief pain exposure therapy (BPET)Participants will complete daily logs for 7-days pre-treatment baseline, along with 21 days during the intervention protocol (fibromyalgia participants only will complete the daily logs), and 7 for days post-treatment. Brief Pain Exposure Therapy will be given for 3 weeks, 1.5 hours per week, telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, mindfulness meditation, and graded exposure techniques for improving tolerance of painful or feared activities. Participants will also be provided handouts and pre-recorded meditation and imagery scripts that participants can use to facilitate between-session practices. In addition, participants will complete surveys through-out the study. | Behavioural | Brief pain exposure therapy (BPET) |
Primary outcome
Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)
Time frame: Day 1, Day 60
This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).
9 secondary outcomes
Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)
Time frame: Day 1, Day 60
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)
Time frame: Day 1, Day 60
Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)
Time frame: Day 1, Day 210
Change in TSK from day 1 (T1) to day 210 (T8)
Time frame: Day 1, Day 210
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)
Time frame: Day 1, Day 210
Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)
Time frame: Day 29
Feasibility based on the number of sessions attended
Time frame: Day 29
Feasibility based on the number of in-session and between-session practices completed
Time frame: Day 29
Feasibility based on open-ended feedback at the completion of the intervention
Time frame: Day 29
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 11 May 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.
John Sturgeon, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief pain exposure therapy (BPET) in people with Fibromyalgia and Lupus Erythematosus, Systemic, run by University of Michigan 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 13 inclusion and 9 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 11 May 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 Beth Banner (734-998-5837, eledward@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5) (time frame: Day 1, Day 60). 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 11 May 2026.