Brief Pain Exposure Therapy (BPET) for Nociplastic Pain
- Conditions
- FibromyalgiaLupus Erythematosus, Systemic
- Interventions
- Behavioral: Brief pain exposure therapy (BPET)
- Registration Number
- NCT06208514
- Lead Sponsor
- University of Michigan
- Brief Summary
This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM) and Lupus learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia and Lupus (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 a title update and adding Lupus participants on to the study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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).
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brief pain exposure therapy (BPET) Brief pain exposure therapy (BPET) -
- Primary Outcome Measures
Name Time Method Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5) 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).
- Secondary Outcome Measures
Name Time Method Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) 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).
Feasibility based on open-ended feedback at the completion of the intervention Day 29 Participants will complete the open-ended feedback form that has 4 questions regarding the intervention and will be summarized.
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8) 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.
Feasibility based on the number of in-session and between-session practices completed Day 29 Higher number of sessions and between-sessions completed shows higher level of feasibility.
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5) 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.
Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5) 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.Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8) 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).
Feasibility based on the number of sessions attended Day 29 Higher number of sessions attended shows higher level of feasibility.
Change in TSK from day 1 (T1) to day 210 (T8) 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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States