JMIR Publications

ABSTRACT

Background:

Systemic lupus erythematosus (SLE) presents substantial life challenges, reflecting the complex and heterogeneous nature of the disease. Pain is common and often one of the earliest manifestations of SLE. Skills-based behavioral pain treatments are often inaccessible to patients with SLE, and no SLE-specific evidence exists to guide patient and clinician treatment choices. To fill a pressing evidence gap for SLE pain treatment, “Lupus PROGRESS” is comparing a lower-burden evidence-based behavioral pain treatment with online multi-session cognitive behavioral therapy (CBT; the gold-standard behavioral treatment for chronic pain), while also enhancing diversity and representativeness among patient advisors and the study participants.

Objective:

Lupus PROGRESS is a national, pragmatic, randomized, non-inferiority trial comparing the effectiveness of two evidence-based behavioral pain treatments, online 8-session cognitive behavioral therapy (CBT; the gold-standard behavioral treatment for chronic pain) vs. 1-session Empowered Relief in U.S. adults with SLE and chronic pain, for reducing pain intensity and pain interference at 3 months post-treatment (multi-primary endpoints).

Methods:

One hundred fifty adults with SLE and pain (≥3 months, intensity ≥3/10) will be enrolled from academic medicine, community health network, and insurance payer study sites. Participants are randomized 1:1 to either 1-session Empowered Relief (ER) or 8-session CBT, with both treatments delivered online to groups. Mixed model repeated measures and intention to treat analytic approaches will be used to test comparative effectiveness aims from baseline to 3 months post-treatment (primary endpoint). Multi-primary outcomes are change in pain intensity and pain interference; priority secondary outcomes are sleep disturbance, pain catastrophizing, pain bothersomeness and anxiety; and other secondary outcomes are satisfaction with roles and responsibilities, global impression of change, anger, fatigue and depression. Durability of effects will be tested at 6 months post-treatment. ER is hypothesized to have superior treatment completion/adherence and lower treatment burden ratings than CBT. In exploratory analyses we will compare healthcare utilization using medical record and claims data 3 months prior to enrollment to last 3 study months, hypothesizing reduced non-inferiority in reduced utilization. The study also incorporates a multi-level patient engagement infrastructure to improve accessibility, recruitment, and study relevance.

Results:

As of May 2026, we have enrolled 130 participants. Enrollment is anticipated to end September 2026, with treatments completed by February 2027, and full analyses completed by November 2027.

Conclusions:

Lupus PROGRESS will provide real-world pragmatic evidence on whether a 1-session online group skills-based treatment is non-inferior to 8-session CBT Results from this patient-centered study will inform more accessible, equitable, and patient-centered chronic pain care for people living with lupus. Clinical Trial: ClinicalTrials.gov: NCT 05612750 (https://clinicaltrials.gov/study/NCT05612750)