NCT07282392 · University of Utah
Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET)
(EAET)
What this study is about
The goal of this clinical trial is to learn if a psychotherapy intervention works to relieve widespread pain in patients with lupus.
View original scientific description
The goal of this clinical trial is to learn if a psychotherapy intervention works to relieve widespread pain in patients with lupus. The main questions it aims to answer are: Is the psychotherapy treatment safe for lupus patients? Are lupus patients able to complete the treatment? Can the treatment help improve chronic pain and other symptoms in lupus patients? Researchers will compare the treatment to a control (participants who will continue their medical treatment but will not receive psychotherapy for the time frame of the treatment) to see if the psychotherapy treatment works to relieve widespread pain and other lupus-related symptoms. Participants will: Fill out questionnaires before and after the treatment. Participate in 8 weekly treatment sessions, 2 hours per session, delivered via Zoom from their own home. Keep a list of medications and monitor any changes in their medication regimen.
Interventions
BEHAVIORAL
Emotional Awareness and Expression Therapy (EAET)
EAET is a novel psychotherapy based on the well-supported finding that adverse, stressful, or traumatic life experiences result in maladaptive emotional experiences that can trigger or amplify pain and other symptoms. EAET showed promising results in fibromyalgia and migraines, as well as musculoskeletal pain, and was found to be more efficacious than CBT, the recommended treatment for chronic pain.
Primary outcome measures
Widespread pain index at baseline
Time frame: From enrollment to the end of treatment at 8 weeks
A licensed rheumatologist will ask participants to identify 19 areas where they felt pain over the past week. The score ranges from 0 to 19 (the number of bodily regions).
Widespread pain index a week after treatment compared to baseline
Time frame: 9 weeks after commencement of treatment
A licensed rheumatologist will ask participants how many body areas they felt pain in during the week after treatment. The score ranges from 0 to 19, and the change in score will be compared with the baseline score. A lower score after treatment indicates the treatment's effectiveness in reducing widespread pain.
Symptom Severity Score at baseline
Time frame: 1 week before the treatment
A licensed rheumatologist will evaluate the symptom severity and somatic symptoms over the past week at baseline using a 0-3 scale.
Change in the severity scale after treatment compared to baseline.
Time frame: 9 weeks after commencement of treatment
A change in symptom severity will be evalauted by comparing the symptom severity score after treatment to baseline. A lower severity score after treatment indicates the treatment's effectiveness in reducing somatic symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 29, 2025 · Source of record for eligibility and locations