The Impact of an Internet-Delivered Cognitive Behavioural Therapy Pain Management Programme (PMP) on People With Spinal Cord Injuries: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
To establish the effectiveness of an internet-delivered cognitive behavioural therapy pain management programme (CBT-PMP) on people with spinal cord injury pain compared with usual care.
详细描述
A pilot prospective, single blinded, randomised controlled trial with two arms an internet-delivered CBT-PMP for chronic pain post spinal cord injury (SCI) and usual care.
The CBT-PMP will contain 8 sessions over 8 weeks, with outcomes assessed at baseline, post intervention, and 6 months follow-up.
Participants will be adults with chronic pain (pain > 3 months), regular internet access and not undergoing any other psychological treatments.
Following the study those in the intervention strand will be invited to complete a focus group to explore the subjects' overall experience of the online CBT-PMP.
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
- 是
入选标准
- •Traumatic or non-traumatic SCI
- •Chronic SCI pain of more than three months.
- •Discharged from acute hospital and rehabilitation services.
- •Males/Females >18years.
- •Regular computer and Internet access and working knowledge of the internet.
- •Fluency in English (verbal and written).
排除标准
- •Those who have completed a PMP before
- •Mental health issue which requiring psychiatric management.
- •Acute injury, currently under specialist medical care.
- •Patients with confounding co-morbidities such as cancer, unstable angina / uncontrolled cardiac arrhythmias/ severe aortic stenosis, acute systemic infection accompanied by fever, systemic/inflammatory diseases eg rheumatoid arthritis/substance abuse/significant mental health issues.
结局指标
主要结局
Quality of life
时间窗: Change from baseline to six weeks and three months.
Quality of life as measured by the WHO QoL Bref
次要结局
- Sleep(Change from baseline to six weeks and three months.)
- Mood(Change from baseline to six weeks and three months.)
- Pain acceptance(Change from baseline to six weeks and three months.)
- Patients impression of change(Change from baseline to six weeks and three months.)
- Pain(Change from baseline to six weeks and three months.)
- Pain interference(Change from baseline to six weeks and three months.)
研究者
Dearbhla Burke
PhD Candidate
University College Dublin