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.
研究组 & 干预措施
Online programme
SPIRE The programme consists of six modules over six weeks and is based on cognitive behavioural principles. It comprises psychology sessions using cognitive techniques to identify unhelpful and unrealistic thoughts and beliefs related to pain and to challenge and change them and weekly relaxation audios and a home exercise session. Goal setting by participants is used encouraged throughout the programme to aid the implementation of learned CBT techniques into daily life. Educational sessions are delivered across a range of topics including mechanisms of pain after SCI, explanations of the pain gate control theory and how CBT strategies employed can impact on the perception of pain, discussion of medication use, stress management and pacing strategies for activities of daily living.
干预措施: SPIRE (Other)
Usual Care
Continue to manage pain using usual care.
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