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

N/AActive Not RecruitingNCT07196072

University of Michigan15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

SLE (Systemic Lupus)Chronic Pain

Interventions

MiPALBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Participants may be withdrawn from the study if they start any such therapies during their study participation.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: End of participation, up to 13 weeks

Secondary Outcomes

Patient Global Impression of Change (PGIC) score

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

Time frame: Up to 13 weeks

Data from ClinicalTrials.gov

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