Chronic Pain, SLE (Systemic Lupus)
Conditions
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.
Interventions
BEHAVIORALMiPAL
MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.
Sponsors
University of Michigan
Rheumatology Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a single site, single-arm, and open label feasibility study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Participants may be withdrawn from the study if they start any such therapies during their study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDominique Kinnett-Hopkins, PhD
University of Michigan
PRINCIPAL_INVESTIGATORRachel Bergmans, MPH, PhD
University of Michigan
Outcome results
None listed