A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain

Not Applicable

Not yet recruiting

• Conditions: SLE (Systemic Lupus); Chronic Pain

• Registration Number: NCT07196072
• Lead Sponsor: University of Michigan

Brief Summary

This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions.
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

1. Taking >10 mg of prednisone (or equivalent steroid dose) per day.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of participants recruited	Baseline, when participants complete informed consent and enroll in the study.	Defined by the number of participants who enroll in the study compared to the target recruitment number (i.e., n=15 anticipated)
Proportion of enrolled participants who complete the study protocol	End of participation, up to 13 weeks	The proportion of enrolled participants who complete the study protocol (i.e., study activities for the 13-week follow up)

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) score	Up to 13 weeks	This is a 1-item survey that measures patient perceptions of intervention success. This survey is scored from 1 to 7, where lower scores indicate a better outcome.; Researchers will consider the intervention to make participants feel better overall if their score = 1, 2, or 3

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States