Empowered Relief versus Cognitive Behavioral Therapy for patients with Systemic Lupus Erythematosus and chronic pain: Protocol for a national comparative effectiveness non-inferiority trial (Preprint)

Authors:
Preprint
Publisher website
Google Scholar
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. CLINICALTRIAL ClinicalTrials.gov: NCT 05612750 (https://clinicaltrials.gov/study/NCT05612750)