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

NCT07282392 | Recruiting

• 1 other identifier: IRB_00194480
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Widespread Pain; Lupus; Fibromyalgia (FM)

Keywords

lupus; fibromyalgia; chronic widespread pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• 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

Other Outcomes (2)

• Satisfaction with therapy and therapist.

  8 weeks after commencement of treatment

• Satisfaction from the telemedicine questionnaire.

  8 weeks after commencement of treatment.

Study Arms (2)

Emotional Awareness and Expression Therapy

EXPERIMENTAL

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)

Wait list control

NO INTERVENTION

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.

Interventions

Emotional Awareness and Expression Therapy (EAET) BEHAVIORAL

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.

Emotional Awareness and Expression Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 38869899 BACKGROUND

• 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.

  PMID: 32451528 BACKGROUND

• 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.

  PMID: 28796118 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dan Kaufmann, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Kaufmann, PhD

CONTACT

385-351-9058; dan.kaufmann@hsc.utah.edu

Dalia Sriwi, MD

CONTACT

801-581-7724; Dalia.Sriwi@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): November 4, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)