Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET)
Purpose
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.
Conditions
- Lupus
- Fibromyalgia (FM)
- Chronic Widespread Pain
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Emotional Awareness and Expression Therapy |
The treatment will be will be conducted via video telemedicine (HIPAA-compliant Zoom), in small groups of patients, for eight weekly sessions, 2 hours per session. Each session will use an educational lecture, discussion, in-class experiential exercises, and homework assignments. During sessions, participants will be encouraged to identify their stressors and experience, and to express their avoided or suppressed emotions, using exercises such as emotional disclosure, role-playing, and the "empty chair" technique. Participants will be given homework assignments to complete between sessions, including expressive writing, identifying stressors and avoided emotions, and practicing healthy communication skills. |
|
|
No Intervention Wait list control |
Participants assigned to the waitlist control condition will be assessed at baseline and at a time matched to EAET post-treatment. All interested participants will be offered the opportunity to receive the EAET treatment once their WL period is completed. Those who opt to receive the treatment will be required to complete another set of assessments again post-treatment. |
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Recruiting Locations
Salt Lake City 5780993, Utah 5549030 84112
More Details
- Status
- Recruiting
- Sponsor
- University of Utah
Detailed Description
Lupus is a serious and lifelong illness, causing flare-ups and damage to organs. It leads to a higher risk of death and a lower quality of life. Difficult life experiences, such as trauma or childhood adversity, are more common in people with lupus and fibromyalgia. These early experiences also raise the risk of anxiety, depression, and developing lupus later in life. This study will test a new therapy, Emotional Awareness and Expression Therapy (EAET). EAET helps people understand and express emotions related to difficult past experiences, which may reduce physical pain and improve overall health. This study wants to see if EAET will help people with lupus who also suffer from chronic widespread pain (or fibromyalgia) and is safe. Participants in the study will be randomly assigned to receive EAET therapy via telehealth or to a waiting list. The study will see if the treatment helps reduce lupus flares, pain, fatigue, anxiety, depression, and improve quality of life and sleep. The EAET group will attend 8 two-hour online group therapy sessions once a week for 8 weeks. This group will also complete homework for about 30 minutes a day during participation. The wait list group will wait for 8 weeks until the EAET group is done. Both groups will complete surveys. The wait list group can choose to participate in the next therapy group session.