NCT06208514 · University of Michigan
Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
(BPET)
What this study is about
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).
View original scientific description
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).
Interventions
BEHAVIORAL
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.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 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
Exclusion criteria
- 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.
- 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
Where
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations