Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Disability as measured by Pain Disability Index
研究概览
简要总结
The purpose of this study is to determine whether a specifically tailored value-based cognitive behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury.
详细描述
The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. Methods. The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disability as measured by Pain Disability Index
时间窗: Change scores at 12- and 24-weeks after randomization
The PDI measures how pain interferes with daily life activities within 7 different domains. The 7 domains are rated from 0 (no disability) to 10 (worst disability). The scale shows good reliability and validity.
次要结局
- Pain by NDI(Change scores at 12- and 24-weeks after randomization)
- Pain by NRS(Change scores at 12- and 24-weeks after randomization)
- Fear of re-injury by TSK(Change scores at 12- and 24-weeks after randomization)
- PTSD-symptomatology(Change scores at 12- and 24-weeks after randomization)
- Pain-related catastrophizing by PCS(Change scores at 12- and 24-weeks after randomization)
- Anxiety and depression by HADS(Change scores at 12- and 24-weeks after randomization)
研究者
Tonny Elmose Andersen, phd.
MSc., Ph.D
University of Southern Denmark