Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Persistent Whiplash Associated Disorders After Road Traffic Accidents: Protocol for a Multiple Baselines Single-case Experimental Design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Value-based living
研究概览
简要总结
The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are:
- What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?
- What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?
Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •have persistent symptoms after a whiplash injury that happened more than 3 months ago
- •have pain and disability defined as > 35 % on Neck Disability Index (NDI)
- •be 18 years or older
- •speak and read Danish
排除标准
- •denote headache as the primary problem
- •show red flags in the neurological and physiotherapeutic examination such as known or suspected serious spinal pathology, confirmed fracture or dislocation in the neck at the time of injury or signs of nerve root compromise (weakness, reflex changes or sensory loss)
- •have had spinal surgery within the past 12 months
- •are socially and occupationally unresolved
- •have daily significant functional limitations related to other pain conditions
- •have severe psychiatric illness
- •are pregnant
- •are not willing or able to respond to items on a daily basis.
结局指标
主要结局
Value-based living
时间窗: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of value-based living.
Pain interference
时间窗: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.
次要结局
- Stress(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Pain catastrophizing(Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).)
- Positive affect(Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).)
- Fatigue(Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).)
- Health-related quality of life(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Negative affect(Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).)
- Pain-related acceptance(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Pain-related self-efficacy(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Neck Disability(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Depression(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Sleep quality(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Pain severity(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Pain Disability(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Anxiety(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Self-perceived improvement(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Satisfaction with treatment(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
研究者
Tonny Elmose Andersen, phd.
Professor
University of Southern Denmark