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NCT Number: NCT07282392

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

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.

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Key information

Conditions

Lupus Chronic Pain Chronic Widespread Pain Fibromyalgia Fibromyalgia (FM) Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

  1. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at baseline.

    Time frame: A week before treatment

    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.

  2. Change in SLEDAI measure after treatment compared to baseline.

    Time frame: 9 weeks after commencement of treatment

    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.

  3. Lupus-specific quality of life (LupusQol) index at baseline.

    Time frame: 1 week before commencement of treatment

    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.

  4. Change in lupus-related quality of life after treatment compared to baseline.

    Time frame: 9 weeks following commencement of treatment

    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.

  5. Fatigue at baseline

    Time frame: 1 week before commencement of treatment

    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.

  6. Change in fatigue score after treatment compared to baseline.

    Time frame: 9 weeks following commencement of treatment

    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.

  7. Anxiety levels at baseline.

    Time frame: 1 week before the treatment.

    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.

  8. Change in anxiety levels after treatment compared to baseline.

    Time frame: 9 weeks after commencement of treatment

    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. Depression levels at baseline.

    Time frame: 1 week before treatment

    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.

  10. Change in depression after treatment compared to baseline.

    Time frame: 9 weeks after commencement of treatment.

    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.

  11. Sleep disturbance at baseline.

    Time frame: 1 week prior to the commencement of therapy

    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.

  12. Change in sleep disturbance after treatment compared to baseline.

    Time frame: 9 weeks after the commencement of treatment

    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.

  13. Sleep-related impairment at baseline.

    Time frame: 1 week before commencement of treatment

    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.

  14. Change in sleep impairment after treatment compared to baseline.

    Time frame: 9 weeks after commencement of treatment.

    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.

Other outcomes

  1. Satisfaction with therapy and therapist.

    Time frame: 8 weeks after commencement of treatment

    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.

  2. Satisfaction from the telemedicine questionnaire.

    Time frame: 8 weeks after commencement of treatment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Sriwi, MD

CONTACT

[email protected]

801-581-7724

Dan Kaufmann, PhD

CONTACT

[email protected]

385-351-9058

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: EAET

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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