Evaluating the Feasibility and Efficacy of Emotional Awareness and Expression Therapy (EAET) on Fibromyalgia Outcomes in Patients With Systemic Lupus Erythematosus (SLE).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Widespread pain index at baseline
Study Overview
Brief Summary
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.
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 eight 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults of all genders, ages 18-
- •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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in SLEDAI measure after treatment compared to baseline.(9 weeks after commencement of treatment)
- Fatigue at baseline(1 week before commencement of treatment)
- Change in anxiety levels after treatment compared to baseline.(9 weeks after commencement of treatment)
- Depression levels at baseline.(1 week before treatment)
- Change in depression after treatment compared to baseline.(9 weeks after commencement of treatment.)
- Sleep-related impairment at baseline.(1 week before commencement of treatment)
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at baseline.(A week before treatment)
- Change in SLEDAI measure after treatment compared to baseline.(9 weeks after commencement of treatment)
- Lupus-specific quality of life (LupusQol) index at baseline.(1 week before commencement of treatment)
- Change in lupus-related quality of life after treatment compared to baseline.(9 weeks following commencement of treatment)
- Fatigue at baseline(1 week before commencement of treatment)
- Change in fatigue score after treatment compared to baseline.(9 weeks following commencement of treatment)
- Anxiety levels at baseline.(1 week before the treatment.)
- Change in anxiety levels after treatment compared to baseline.(9 weeks after commencement of treatment)
- Depression levels at baseline.(1 week before treatment)
- Change in depression after treatment compared to baseline.(9 weeks after commencement of treatment.)
- Sleep disturbance at baseline.(1 week prior to the commencement of therapy)
- Change in sleep disturbance after treatment compared to baseline.(9 weeks after the commencement of treatment)
- Sleep-related impairment at baseline.(1 week before commencement of treatment)
- Change in sleep impairment after treatment compared to baseline.(9 weeks after commencement of treatment.)
Investigators
Dan Kaufmann, Ph.D.
Assistant Professor
University of Utah