Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Spinal Cord Injury 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
- 6
- 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 spinal cord injury. 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 spinal cord injury?
- 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). Nine 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 either in person at Specialized Hospital for Polio and Accident Victims or virtually via secure videoconferencing 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
- •be 18 years or older
- •speak and read Danish
- •aquired spinal cord injury
- •paraplegia or tetraplegia (either complete or incomplete)
- •daily pain
- •therapy-ready and motivated for this treatment type
- •willing to engage in homework
- •willing to respond to daily questionnaires
- •able to attend weekly sessions without payment
排除标准
- •any red flags during physiotherapeutic examination
- •acute or sub-acute stage
- •current pressure ulcers
- •known and unstable psychiatric disorder
- •syringomyelia
- •pregnancy
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
- 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).)
- Negative affect(Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).)
- Stress(Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion)
- Fatigue(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)
- 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)
- Depression(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)
- 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)
- Sleep quality(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
Anders Orup Aaby
Guest researcher
University of Southern Denmark