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

NCT07196072 | Active Not Recruiting

• 1 other identifier: HUM00264850
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

SLE (Systemic Lupus); Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Proportion of participants recruited

  Defined by the number of participants who enroll in the study compared to the target recruitment number (i.e., n=15 anticipated)

  Baseline, when participants complete informed consent and enroll in the study.

• Proportion of enrolled participants who complete the study protocol

  The proportion of enrolled participants who complete the study protocol (i.e., study activities for the 13-week follow up)

  End of participation, up to 13 weeks

Secondary Outcomes (1)

• Patient Global Impression of Change (PGIC) score

  Up to 13 weeks

Study Arms (1)

MiPAL participant

EXPERIMENTAL

All study participants who meet eligibility criteria.

Behavioral: MiPAL

Interventions

MiPAL BEHAVIORAL

MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.

MiPAL participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions.
• 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.
• Stable doses of lupus-related medications, including prednisone, for 3 months prior to study entry.
• 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).
• Willingness to attend all study visits, including attending recorded virtual coaching sessions for the duration of study.
• Willingness to engage in yoga practices outlined in the MiPAL program.
• Access to necessary resources for participating in a remote intervention, including a smartphone, computer, or tablet with internet

You may not qualify if:

• Taking \>10 mg of prednisone (or equivalent steroid dose) per day.
• Unable to attend study visits.
• Pregnancy.
• Concurrent participation in other behavioral, psychotherapeutic, or pharmacological trials.
• 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.
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Chronic Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Kinnett-Hopkins, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Rachel Bergmans, MPH, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Model Details: This is a single site, single-arm, and open label feasibility study.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)