Emotional Awareness and Expression Therapy to reduce widespread pain in lupus
Evaluating the Feasibility and Efficacy of Emotional Awareness and Expression Therapy (EAET) on Fibromyalgia Outcomes in Patients With Systemic Lupus Erythematosus (SLE).
This program will test whether an online emotional-awareness therapy (EAET) can reduce chronic widespread pain and other symptoms in adults with lupus who have fibromyalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT07282392 on ClinicalTrials.gov |
What this trial studies
This randomized study will compare eight weekly two-hour group EAET sessions delivered via Zoom plus daily homework to a wait-list control among adults with lupus and chronic widespread pain. Participants will complete questionnaires before and after the 8-week intervention to measure pain, lupus flares, fatigue, mood, sleep, and quality of life, and investigators will track medication changes and adverse events. The EAET intervention teaches recognition and expression of emotions tied to past stress or trauma as a route to reducing centralized pain. Primary aims are to determine safety, feasibility (ability to complete the treatment), and whether EAET reduces pain and other lupus-related symptoms.
Who should consider this trial
Good fit: Adults aged 18–65 with rheumatologist-diagnosed lupus and coexisting fibromyalgia or chronic widespread pain, on a stable medication regimen, who can use a computer or smartphone and communicate in English.
Not a fit: People with uncontrolled serious psychiatric disorders, active suicidal ideation, untreated substance use disorder, substantial cognitive impairment, recent medication changes, inability to use the internet, or who do not have chronic widespread pain are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, EAET could reduce chronic pain and improve mood, sleep, and quality of life for people with lupus without requiring medication changes.
How similar studies have performed: Prior randomized and nonrandomized studies of EAET and related emotional-expression therapies have shown benefit for fibromyalgia and centralized pain, but applying EAET specifically to people with lupus and widespread pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults of all genders, ages 18-65. * A diagnosis of lupus and fibromyalgia or chronic widespread pain by a licensed rheumatologist * Be on a stable medication regimen. Exclusion Criteria: * Serious psychiatric disorders (e.g., schizophrenia or bipolar disorder) uncontrolled with medications. * Active suicidal ideation. * Untreated alcohol or substance use disorder. * Substantial cognitive impairment. * Changes in medications in the past 3 months. * Enrollment in another treatment study. * Current involvement in health-related litigation or disability application. * Inability to use a computer and/or smartphone. * limited access to the internet. * Inability to communicate in English. * Failure to complete the baseline assessments.
Where this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Dan Kaufmann, PhD — University of Utah
- Study coordinator: Dan Kaufmann, PhD
- Email: dan.kaufmann@hsc.utah.edu
- Phone: 385-351-9058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.