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)

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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. Skill-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, the Lupus PROGRESS (Pain Relief With Online Groups That Empower Skill-Based Symptom Reduction) trial will compare a lower-burden evidence-based behavioral pain treatment with online multisession cognitive behavioral therapy (CBT; the gold standard behavioral treatment for chronic pain) while also enhancing diversity and representativeness among patient advisors and study participants. Objective: Lupus PROGRESS is a national, pragmatic, randomized noninferiority trial comparing the effectiveness of 2 evidence-based behavioral pain treatments (online 8-session CBT vs 1 session the Empowered Relief program; Stanford University) in adults with SLE and chronic pain in the United States for reducing pain intensity and pain interference at 3 months after treatment (multiple primary end points). Methods: In total, 150 adults with SLE and pain (≥3 months, intensity of ≥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 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 after treatment (the primary end point). Multiple primary outcomes are 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 and global impression of change, anger, fatigue, and depression. Durability of effects will be tested at 6 months after treatment. Empowered Relief is hypothesized to have superior treatment completion and adherence and lower treatment burden ratings than CBT. In exploratory analyses, we will compare health care use through medical record and claims data 3 months prior to enrollment to the last 3 study months, hypothesizing reduced noninferiority in reduced use. The study also incorporates a multilevel 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 in November 2026, with treatments completed by April 2027 and full analyses completed by February 2028. Conclusions: Lupus PROGRESS will provide real-world pragmatic evidence on whether a 1-session online group skill-based treatment is noninferior 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. Trial Registration: ClinicalTrials.gov NCT05612750; https://clinicaltrials.gov/study/NCT05612750 International Registered Report Identifier (IRRID): DERR1-10.2196/100104

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