Recruiting

Psychotherapy

Sponsor:

University of Utah

Code:

NCT07282392

Conditions

Lupus

Fibromyalgia (FM)

Chronic Widespread Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Emotional Awareness and Expression Therapy (EAET)

Study Details

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

Lupus

Fibromyalgia (FM)

Chronic Widespread Pain

Study ID

NCT07282392

Start date

Dec 1, 2025

Status verified date

Dec, 2025

Completion date

Nov 4, 2028

Anticipated

Primary completion date

Oct 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Widespread pain index at baseline [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Widespread pain index a week after treatment compared to baseline [ Time Frame: 9 weeks after commencement of treatment ]
  • Symptom Severity Score at baseline [ Time Frame: 1 week before the treatment ]
  • Change in the severity scale after treatment compared to baseline. [ Time Frame: 9 weeks after commencement of treatment ]

Central Contacts and Locations

Central contacts

Dan Kaufmann, PhD

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

Dalia Sriwi, MD

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

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Dan Kaufmann

8019138091dan.kaufmann@hsc.utah.edu

Dalia Sriwi, MD

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

More Information

Sponsor

University of Utah

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • lupus
  • fibromyalgia
  • chronic widespread pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-12-29.