Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET) (EAET)

Evaluating the Feasibility and Efficacy of Emotional Awareness and Expression Therapy (EAET) on Fibromyalgia Outcomes in Patients With Systemic Lupus Erythematosus (SLE).

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Widespread Pain; Lupus; Fibromyalgia (FM)
• Intervention / Treatment: Behavioral: Emotional Awareness and Expression Therapy (EAET)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Kaufmann, PhD; Phone Number: 385-351-9058; Email: dan.kaufmann@hsc.utah.edu
• Study Contact Backup: Name: Dalia Sriwi, MD; Phone Number: 801-581-7724; Email: Dalia.Sriwi@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Dalia Sriwi, MD; Phone Number: 801-581-7724; Email: Dalia.Sriwi@hsc.utah.edu
      • Contact: Dan Kaufmann; Phone Number: 8019138091; Email: dan.kaufmann@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotional Awareness and Expression Therapy; The treatment will be conducted via HIPAA-compliant video telemedicine (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 experiences, 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.	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.
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 post-treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 8 weeks
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.	9 weeks after commencement of treatment
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.	1 week before the treatment
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.	9 weeks after commencement of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 weeks after commencement of treatment
Fatigue at baseline	Fatigue will be evaluated at baseline using the patient-administered Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue). The score ranges from 0 to 52. A higher score indicates higher fatigue.	1 week before commencement of treatment
Change in anxiety levels after treatment compared to baseline.	A change in anxiety will be evaluated by comparing the PROMIS anxiety questionnaire score after treatment to baseline. A lower anxiety score after treatment will indicate the effectiveness of treatment in reducing anxiety.	9 weeks after commencement of treatment
Depression levels at baseline.	Depression will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) short depression questionnaire. The minimum score is 8, and the maximum score is 40. A higher score indicates a higher level of depression.	1 week before treatment
Change in depression after treatment compared to baseline.	A Change in depression score will be evaluated by comparing the PROMIS depression questionnaire score after treatment vs. baseline. A lower score will indicate the effectiveness of treatment in relieving depression.	9 weeks after commencement of treatment.
Sleep-related impairment at baseline.	Sleep-related impairment will be evalauted using the participant-administered PROMIS sleep-related impairment short form 8a. The scores range from 8 to 40, with higher scores indicating greater sleep-related impairment.	1 week before commencement of treatment
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.	A week before treatment
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.	1 week before commencement of treatment
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.	9 weeks following commencement of treatment
Change in fatigue score after treatment compared to baseline.	The FACIT-Fatigue scale will be administered after treatment, and the score will be compared with the baseline. A lower score indicates that the therapy improved fatigue.	9 weeks following commencement of treatment
Anxiety levels at baseline.	Anxiety will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) short anxiety questionnaire. The minimum value is 8, and the maximum value is 40. A higher score on this test indicates higher levels of anxiety.	1 week before the treatment.
Sleep disturbance at baseline.	Sleep disturbance will be evalauted using the patient-administered PROMIS- sleep disturbance short form. The scores range from 8 to 40, with higher scores indicating a greater severity of sleep disturbance.	1 week prior to the commencement of therapy
Change in sleep disturbance after treatment compared to baseline.	The sleep disturbance score will be collected after treatment and compared with the baseline score. A lower score indicates that the therapy reduced sleep disturbance.	9 weeks after the commencement of treatment
Change in sleep impairment after treatment compared to baseline.	Sleep-related impairment will be scored after treatment and compared to the baseline score. A reduction in overall score indicates that the treatment was effective in reducing sleep-related impairment.	9 weeks after commencement of treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks after commencement of treatment
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.	8 weeks after commencement of treatment.

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Dan Kaufmann, PhD, University of Utah

Publications and helpful links

General Publications

• Yarns BC, Lumley MA, Cassidy JT, Steers WN, Osato S, Schubiner H, Sultzer DL. Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial. Pain Med. 2020 Nov 1;21(11):2811-2822. doi: 10.1093/pm/pnaa145.
• Lumley MA, Schubiner H, Lockhart NA, Kidwell KM, Harte SE, Clauw DJ, Williams DA. Emotional awareness and expression therapy, cognitive behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial. Pain. 2017 Dec;158(12):2354-2363. doi: 10.1097/j.pain.0000000000001036.
• Yarns BC, Jackson NJ, Alas A, Melrose RJ, Lumley MA, Sultzer DL. Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415842. doi: 10.1001/jamanetworkopen.2024.15842.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): November 4, 2028

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: fibromyalgia; lupus; chronic widespread pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fibromyalgia; Chronic Pain
• Other Study ID Numbers: IRB_00194480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No