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LupusEAETNCT07282392

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

A study testing Emotional Awareness and Expression Therapy (EAET) in people with Lupus and Fibromyalgia (FM), run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lupus, Fibromyalgia (FM), Chronic Widespread Pain
What is being tested?
Emotional Awareness and Expression Therapy (EAET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Dec 2025to 4 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Utah

    Salt Lake City, Utah, 84112

    Dan Kaufmann, 8019138091, dan.kaufmann@hsc.utah.edu

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

    Recruiting

Other trials in United States

About this study

Official title: 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?

Read more

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.

Read the 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.

Being tested
Emotional Awareness and Expression Therapy (EAET)
Keywords
lupus, fibromyalgia, chronic widespread pain
Medical subject headings
Fibromyalgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Awareness and Expression Therapy (EAET)Behavioural

    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.

Study groups in NCT07282392
Study groupRoleWhat they receive
Emotional Awareness and Expression TherapyExperimentalThe 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.
Receives: Behavioral: Emotional Awareness and Expression Therapy (EAET)
Wait list controlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From enrollment to the end of treatment at 8 weeks

  2. 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.

    Measured: 9 weeks after commencement of treatment

  3. 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.

    Measured: 1 week before the treatment

  4. 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.

    Measured: 9 weeks after commencement of treatment

Secondary outcomes (14)
  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.

    Measured: A week before treatment

  2. 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.

    Measured: 9 weeks after commencement of treatment

  3. 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.

    Measured: 1 week before commencement of treatment

  4. 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.

    Measured: 9 weeks following commencement of treatment

  5. 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.

    Measured: 1 week before commencement of treatment

  6. 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.

    Measured: 9 weeks following commencement of treatment

  7. 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.

    Measured: 1 week before the treatment.

  8. 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.

    Measured: 9 weeks after commencement of treatment

  9. 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.

    Measured: 1 week before treatment

  10. 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.

    Measured: 9 weeks after commencement of treatment.

  11. 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.

    Measured: 1 week prior to the commencement of therapy

  12. 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.

    Measured: 9 weeks after the commencement of treatment

  13. 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.

    Measured: 1 week before commencement of treatment

  14. 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.

    Measured: 9 weeks after commencement of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion4 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282392
Sponsor's protocol ID
IRB_00194480
Acronym
EAET
Status last verified
Dec 2025
First submitted
2 Dec 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38869899
  • 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.

    PubMed 32451528
  • 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.

    PubMed 28796118

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Awareness and Expression Therapy (EAET) in people with Lupus and Fibromyalgia (FM), run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dan Kaufmann, PhD (385-351-9058, dan.kaufmann@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Widespread pain index at baseline (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282392, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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