"Empowered Relief" Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 2
- 主要终点
- Trait Pain Catastrophizing (Trait PC)
研究概览
简要总结
This study aims to compare the efficacy of a single session psychological treatment, "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores.
详细描述
This is a randomized 3-arm study comprised of 2 active psychological treatments (ER & CBT) and a health education (HE) arm that controls for time and attention. Study goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the current gold standard group treatment for PC -- manualized 8-session pain-CBT.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Principal Investigators and Statisticians performing analyses will be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Axial low back pain without radicular symptoms
- •Pain duration ≥ 6 months (per recent NIH Task Force on Research Standards for Chronic Low Back Pain based on participant self-report
- •Average pain intensity ≥4/10 for the past month at screening visit
- •English fluency
- •Males and females 18-70 years of age
- •Pain Catastrophizing Score (PCS) ≥20
排除标准
- •Gross cognitive impairment
- •Active suicidal ideation or severe depression
- •Previous attendance in the active treatment groups (any ER classes ever taken or CBT in the past 3 years)
- •Participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptable
- •Current substance abuse
- •Clear likelihood to disrupt fellow class participants (e.g., personality disorder) at the discretion of the study team
结局指标
主要结局
Trait Pain Catastrophizing (Trait PC)
时间窗: 3 months Post-Treatment
Change in Trait Pain Catastrophizing (Trait PC) from baseline to 3 months post-treatment across all treatment groups
次要结局
- Trait PC at 6 months Post-treatment(6 months Post-Treatment)
- PROMIS Measures at 3 months Post-treatment(3 months Post-Treatment)
- Actigraphy for function and sleep(Several time frames from baseline to 3 months Post-Treatment)
研究者
Beth Darnall
Clinical Associate Professor
Stanford University