University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
NCT Number: NCT06208514
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Fibromyalgia participants must have:
Lupus participants must have:
Chronic Low Back Pain participants must have:
Exclusion criteria
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.
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).
Time frame: Day 1, Day 60
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.
Time frame: Day 1, Day 60
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.
Time frame: Day 1, Day 210
This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).
Time frame: Day 1, Day 210
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.
Time frame: Day 1, Day 210
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.
Time frame: Day 29
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).
Time frame: Day 29
Higher number of sessions attended shows higher level of feasibility.
Time frame: Day 29
Higher number of sessions and between-sessions completed shows higher level of feasibility.
Time frame: Day 29
Participants will complete the open-ended feedback form that has 4 questions regarding the intervention and will be summarized.
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
Acronym: BPET
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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