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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief pain exposure therapy (BPET) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief pain exposure therapy (BPET) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1, Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1, Day 60 |
| Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5) |
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Inclusion Criteria:
Fibromyalgia participants must have:
Lupus participants must have:
Chronic Low Back Pain participants must have:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Banner | Contact | 734-998-5837 | eledward@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Sturgeon, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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The enrollment numbers were increased to 125 (from 70) after the University of Michigan Medical School Institutional Review Board approved the amendment.
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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. |
| 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). | 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. | 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. | 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). | Day 29 |
| Feasibility based on the number of sessions attended | Higher number of sessions attended shows higher level of feasibility. | 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. | 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. | Day 29 |
| D009422 |
| Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |