Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Serious psychiatric disorders (e.g., schizophrenia or bipolar disorder) uncontrolled with medications.
Active suicidal ideation.
Untreated alcohol or substance use disorder.
Substantial cognitive impairment.
Trial design
Design model
Parallel
Treatments tested in this trial
Emotional Awareness and Expression Therapy (EAET)
BehavioralEAET 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Emotional Awareness and Expression TherapyExperimental treatment 1 intervention
Group B: Wait list controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Widespread pain index at baseline
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).
Time frame
From enrollment to the end of treatment at 8 weeks2
Widespread pain index a week after treatment compared to baseline
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.
Time frame
9 weeks after commencement of treatment3
Symptom Severity Score at baseline
A licensed rheumatologist will evaluate the symptom severity and somatic symptoms over the past week at baseline using a 0-3 scale.
Time frame
1 week before the treatment4
Change in the severity scale after treatment compared to baseline.
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.
Time frame
9 weeks after commencement of treatmentSecondary outcomes
1
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at baseline.
A licensed rheumatologist will evaluate the disease activity using the SLEDAI questionnaire at baseline. The scale ranges from 0 to 105. 0 indicates no disease activity; 1-5, mild disease activity; 6-10, a clinically meaningful cutoff indicating moderate disease activity; 11-19, high disease activity; and 20 or more, very high disease activity.
Time frame
A week before treatment2
Change in SLEDAI measure after treatment compared to baseline.
A licensed rheumatologist will evaluate the disease activity using the SLEDAI questionnaire after treatment. A lower score after treatment indicates the treatment's effectiveness in reducing lupus disease activity.
Time frame
9 weeks after commencement of treatment3
Lupus-specific quality of life (LupusQol) index at baseline.
Lupus-related quality of life will be evaluated using the LupusQol questionnaire, which participants will complete. Scores range from 0 to 100. Higher scores indicate a higher quality of life.
Time frame
1 week before commencement of treatment4
Change in lupus-related quality of life after treatment compared to baseline.
Changes in Lupus-related quality of life will be evaluated by comparing scores on the LupusQol questionnaire after treatment with baseline scores. Higher scores indicate that the therapy increased participants' quality of life.
Time frame
9 weeks following commencement of treatmentOther outcomes
1
Satisfaction with therapy and therapist.
Satisfaction with therapy and the therapist will be evaluated using the STTS-R inventory. Scores range from 13 to 65. Higher scores indicate higher satisfaction with therapists and treatment.
Time frame
8 weeks after commencement of treatment2
Satisfaction from the telemedicine questionnaire.
Participants will complete the Satisfaction with telemedicine questionnaire, which assesses participants' satisfaction with the telehealth platform. The scores range from 14 to 70, with higher scores indicating greater satisfaction with telehealth.
Time frame
8 weeks after commencement of treatment.Sponsors and contacts
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Source ClinicalTrials.gov