A Pragmatic Trial of Emotional Awareness and Expression Therapy for Veterans With Chronic Pain: Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 672
- 试验地点
- 1
- 主要终点
- Change in "pain severity" from baseline to 10 weeks, 6 months, and 12 months post baseline
研究概览
简要总结
About one in three Veterans lives with long-term (chronic) pain, and many of them also struggle with past trauma and mental health issues like depression, anxiety, or PTSD. Emotional Awareness and Expression Therapy (EAET) is a type of talk therapy that helps people understand and express their emotions, especially those linked to past trauma. This therapy has been shown to help reduce pain and improve mental health.
So far, multiple studies have tested EAET in both Veterans and civilians, and the results have been promising. EAET has helped people feel less pain, move better, and experience fewer mental health symptoms. Because of these strong results, the U.S. Department of Health & Human Services named EAET a Best Practice for managing pain in 2019.
Two earlier studies at a VA hospital in Los Angeles found that EAET worked even better than another well-known therapy called cognitive behavioral therapy for chronic pain (CBT-CP) for older Veterans. However, those studies were done in tightly controlled settings. Now, researchers want to see if EAET works just as well when it's used in everyday healthcare settings, by different types of doctors and therapists.
Doctors and therapists at up to 7 VA hospitals across the country will be trained to use EAET. They will then try it out with Veterans to see how well it works and how easy it is to use in real clinics. Veterans, doctors, and other staff will be asked for feedback to learn what helps or gets in the way of using EAET.
详细描述
Chronic pain is present in nearly one-third of Veterans and is frequently accompanied by comorbid trauma and mental health symptoms. Emotional awareness and expression therapy (EAET) is an evidence-based psychological treatment for chronic pain that was developed to directly target comorbid trauma and mental health symptoms with the goal of reducing or eliminating chronic pain. Multiple controlled and uncontrolled efficacy trials of EAET in Veterans and civilians have shown EAET can produce robust effects on improving outcomes that include pain severity, pain interference, depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms. Consequently, EAET was recommended as a Pain Management Best Practice by the U.S. Department of Health & Human Services in 2019. Moreover, in two single-site efficacy trials conducted at VA Greater Los Angeles Healthcare System, EAET was found to be superior on several outcomes to gold- standard cognitive behavioral therapy for chronic pain (CBT-CP) among older Veterans with chronic pain. Yet these more tightly controlled trials may not reflect the true effectiveness of EAET when implemented by diverse clinicians. The overall goal of the proposed project is to conduct a rigorous and comprehensive evaluation of EAET delivered in usual care settings. The project will proceed in two phases: During a 1-year UG3 phase, clinicians at up to 7 geographically diverse VA healthcare systems will be trained in EAET via an EAET learning collaborative, and a pilot randomized clinical trial of EAET and CBT-CP will be performed at each site to confirm feasibility. In addition, a formative evaluation will be conducted to engage clinicians, administrators, and Veterans and to identify barriers and facilitators to implementation. In Phase 2, we are conducting a pragmatic multisite randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran at one of 7 VA healthcare systems;
- •Age 18 years or older;
- •At least 3 months of musculoskeletal pain, defined using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes, which include the following M-code diagnoses: back pain, fibromyalgia, limb pain, neck pain; R-code diagnoses: pelvic and perineal pain, jaw pain; and G-code diagnoses: tension headaches; and
- •Pain of at least moderate severity, defined as ≥4 "on average" on the 0-10 Numeric Pain Rating Scale
排除标准
- •Poorly controlled major psychiatric illness (e.g., schizophrenia, bipolar I disorder with acute psychotic symptoms, severe manic or depressive episode listed as active in CPRS);
- •Active suicide or violence risk (e.g., currently suicidal or homicidal ideation, intent, or plans);
- •Active severe drug/alcohol use disorder (e.g., drinking more than intended, tried to stop but couldn't, spent significant time drinking or being sick from aftereffects, wanted drink so badly you couldn't think of anything else, interference with home or work life, continued to drink despite problems, given up on activities, dangerous situations, withdrawal and/or tolerance); and
- •Current participation in CBT-CP or EAET, or participation in either intervention in the last 6 months, via clinical care or another research study.
研究组 & 干预措施
Emotional awareness and expression therapy (EAET)
Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
干预措施: Emotional Awareness and Expression Therapy (EAET) (Behavioral)
Cognitive behavioral therapy for chronic pain (CBT-CP)
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
干预措施: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) (Behavioral)
结局指标
主要结局
Change in "pain severity" from baseline to 10 weeks, 6 months, and 12 months post baseline
时间窗: Baseline, along with 10 weeks, 6 months, and 12 months post baseline
Brief Pain Inventory (BPI) Pain Severity. Average of four self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be).
次要结局
- Change in "pain Interference" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "total pain impact" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "physical functioning" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "sleep" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "fatigue" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "pain catastrophizing" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "depression symptoms" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "anxiety symptoms" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "PTSD symptoms" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "substance use screener" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- Change in "World Health Organization Quality of life" from baseline to 10 weeks, 6 months, and 12 months post baseline(Baseline, along with 10 weeks, 6 months, and 12 months post baseline)
- "Patient Global Impression of Change" at 10 weeks, 6 months, and 12 months post baseline(10 weeks, 6 months, and 12 months post baseline)
研究者
Brandon C. Yarns, MD, MS, BME
Principal Investigator
University of California, Los Angeles