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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at baseline. [Срок оценки: A week before treatment]
• Change in SLEDAI measure after treatment compared to baseline. [Срок оценки: 9 weeks after commencement of treatment]
• Lupus-specific quality of life (LupusQol) index at baseline. [Срок оценки: 1 week before commencement of treatment]
• Change in lupus-related quality of life after treatment compared to baseline. [Срок оценки: 9 weeks following commencement of treatment]
• Fatigue at baseline [Срок оценки: 1 week before commencement of treatment]
• Change in fatigue score after treatment compared to baseline. [Срок оценки: 9 weeks following commencement of treatment]
• Anxiety levels at baseline. [Срок оценки: 1 week before the treatment.]
• Change in anxiety levels after treatment compared to baseline. [Срок оценки: 9 weeks after commencement of treatment]
• Depression levels at baseline. [Срок оценки: 1 week before treatment]
• Change in depression after treatment compared to baseline. [Срок оценки: 9 weeks after commencement of treatment.]
• Sleep disturbance at baseline. [Срок оценки: 1 week prior to the commencement of therapy]
• Change in sleep disturbance after treatment compared to baseline. [Срок оценки: 9 weeks after the commencement of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Utah — Salt Lake City

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07282392 · IRB_00194480

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗