A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain
NCT ID: NCT07196072
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-10-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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MiPAL participant
All study participants who meet eligibility criteria.
MiPAL
MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.
Interventions
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MiPAL
MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with systemic lupus erythematosus (SLE). In this study, SLE is classified as meeting the 2019 European League Against Rheumatism/American College of Radiology (ACR) criteria for SLE.
3. Stable doses of lupus-related medications, including prednisone, for 3 months prior to study entry.
4. Reports pain lasting ≥ 3 months and has a sum of ≥8 on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Pain Interference items (assessed at screening).
5. Willingness to attend all study visits, including attending recorded virtual coaching sessions for the duration of study.
6. Willingness to engage in yoga practices outlined in the MiPAL program.
7. Access to necessary resources for participating in a remote intervention, including a smartphone, computer, or tablet with internet
Exclusion Criteria
2. Unable to attend study visits.
3. Pregnancy.
4. Concurrent participation in other behavioral, psychotherapeutic, or pharmacological trials.
5. Any impairment, activity, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol. For example, any condition that impairs the ability to give consent or participate fully in the study.
6. Currently engaged in or starting any therapies (physical, occupational, CBT, psychotherapy, etc.) that are focused on managing chronic pain. Participants may be withdrawn from the study if they start any such therapies during their study participation.
18 Years
ALL
No
Sponsors
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Rheumatology Research Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Rachel Bergmans
Research Investigator
Principal Investigators
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Rachel Bergmans, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Dominique Kinnett-Hopkins, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Vivian Kurtz, MPH
Role: primary
Other Identifiers
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HUM00264850
Identifier Type: -
Identifier Source: org_study_id