Emotional awareness and expression therapy, cognitive behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial.
Mark A Lumley, Howard Schubiner, Nancy A Lockhart...
https://pubmed.ncbi.nlm.nih.gov/28796118/Actively Recruiting
Led by University of Utah · Updated on 2025-12-29
30
Participants Needed
1
Research Sites
2 weeks
Total Duration
This research aims to evaluate whether Emotional Awareness and Expression Therapy EAET, a psychotherapy intervention, can help reduce widespread pain and other symptoms in patients with lupus who also have fibromyalgia or chronic widespread pain. The study will assess if the therapy is safe, if patients can complete the treatment, and if it improves chronic pain and related lupus symptoms compared to a control group receiving usual medical care without psychotherapy during the study period. Participants will be randomly assigned to either the EAET treatment group or a waitlist control group. The EAET group will attend eight weekly 2-hour online group therapy sessions via Zoom, which include educational lectures, discussions, experiential exercises, and homework assignments. The therapy focuses on helping patients express emotions linked to stressful or traumatic experiences. The waitlist group will continue usual care and complete assessments, with an option to receive therapy after the wait period. Participants will complete questionnaires before and after treatment, tracking pain levels, lupus disease activity, fatigue, anxiety, depression, sleep quality, and quality of life. They will also monitor medication use and changes. The studys primary outcome measures include widespread pain index and symptom severity scores assessed before treatment and one week after treatment completion. Secondary measures cover lupus activity, fatigue, mental health, and sleep disturbances. The total treatment period lasts 8 weeks, with follow-up assessments at 9 weeks from treatment start.
CONDITIONS
Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET)
D
Dan Kaufmann, PhD
D
Dalia Sriwi, MD
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University of Utah
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | EAET (Emotional Awareness and Expression Therapy) | Wait List Control |
|---|---|---|
| What it is | A behavioral psychotherapy that helps participants identify and express underlying emotional experiences linked to pain and symptoms. Developed for conditions where psychological stress may amplify chronic pain. | Participants assigned to a wait list did not receive the active EAET treatment during the study but were monitored for baseline symptoms over the same period. |
| Role in the trial | Investigational therapy being tested for its effect on pain and related symptoms in people with lupus and fibromyalgia or chronic widespread pain. | Comparator arm used to track symptom changes in participants not receiving the intervention. |
| Primary use | Designed to reduce widespread pain and symptom severity in adults with lupus and fibromyalgia or chronic widespread pain. | Serves as a non-active comparison to monitor changes in symptoms that occur without behavioral intervention. |
| How it is given or performed | Delivered as a structured psychotherapy, likely involving regular sessions where participants learn emotional awareness and expression skills, often using a group or individual therapy format. | No active therapy is provided during the study period. Participants continue their stable medication and routines. |
| Evidence status | EAET has been studied in randomized trials for fibromyalgia and chronic musculoskeletal pain, showing improved pain outcomes compared to both CBT and education controls. | Serves as a comparison group to estimate natural symptom change and nonspecific effects; no active behavioral intervention or external evidence for clinical effect. |
| Important limitations | Effectiveness in people with both lupus and fibromyalgia has not yet been established, as prior EAET studies focused on fibromyalgia or chronic musculoskeletal pain. Long-term outcomes and benefits compared to established pain therapies remain unknown. | A wait list control does not account for nonspecific treatment effects delivered through therapist or group interaction. Results could differ from those seen with comparator groups receiving conventional pain therapies. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 8 weeks
Participants assigned to the therapy group attend eight weekly 2-hour online group sessions of Emotional Awareness and Expression Therapy (EAET), including homework assignments between sessions. Participants assigned to the wait list control group wait for 8 weeks before optionally receiving the therapy.
Weekly 2-hour online group sessions for 8 weeks
Duration - 1 week after treatment
Participants complete surveys to assess changes in pain, fatigue, anxiety, depression, sleep, and quality of life after treatment or wait period.
1 follow-up survey visit (remote)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mark A Lumley, Howard Schubiner, Nancy A Lockhart...
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https://pubmed.ncbi.nlm.nih.gov/32451528/Brandon C Yarns, Nicholas J Jackson, Alexander Alas...
https://pubmed.ncbi.nlm.nih.gov/38869899/University of Utah
Lead Sponsor