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

University of Michigan

Status: Active, not recruiting

Conditions: Chronic Pain; SLE (Systemic Lupus)

Treatments: Behavioral: MiPAL

Study type: Interventional

Funder types: Other

Identifiers

NCT07196072

HUM00264850

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
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 Participants may be withdrawn from the study if they start any such therapies during their study participation.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MiPAL participant

Experimental group

Description:

All study participants who meet eligibility criteria.

Treatment:

Behavioral: MiPAL