Recruiting

BPET

Sponsor:

University of Michigan

Code:

NCT06208514

Conditions

Fibromyalgia

Lupus Erythematosus, Systemic

Chronic Pelvic Pain

Chronic Low Back Pain (CLBP)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief pain exposure therapy (BPET)

Study Details

Brief 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 chronic low back pain (such as depression or anxiety).

Conditions

Fibromyalgia

Lupus Erythematosus, Systemic

Chronic Pelvic Pain

Chronic Low Back Pain (CLBP)

Study ID

NCT06208514

Start date

Mar 4, 2024

Status verified date

Dec, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brief pain exposure therapy (BPET)

Interventions

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 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 ]

Central Contacts and Locations

Central contacts

Beth Banner

734-998-5837eledward@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Beth Banner

734-998-5837eledward@med.umich.edu

Principal Investigator:

John Sturgeon, PhD

More Information

Sponsor

University of Michigan

Last update posted

May 11, 2026

Last verified

Dec, 2025

Keywords

  • Pain exposure therapy
  • Telehealth-based behavioral intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.