Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Change in Body Sensations Questionnaire (BSQ)
研究概览
简要总结
This study aims to test Implementation of Internet-Assisted Treatment for Non-Cardiac Chest Pain at the Cardiac Department at Sørlandet Hospital. The internet-assisted treatment will be delivered by personnel working at the department. Effectiveness will be tested in an randomized controlled trial (RCT). The intervention has been tested in an RCT where the intervention was delivered by a cognitive behavioral therapy (CBT) specialist who also participated in developing the intervention. Presently the investigators will test if personnel working at the department, with minimal training in CBT, can deliver the intervention effectively.
详细描述
Most patients with chest pain referred to hospital do not have a cardiac illness. Non-cardiac chest pain (NCCP) is often followed by persistent distress and reduced quality of life, and societal costs are nearly equal to those of cardiac patients. Research suggests that face-to-face CBT is effective, but this has not been implemented as standard treatment. The investigators plan to test an easily implementable internet-assisted treatment for NCCP patients delivered by personnel already working at the department.
Patients will be recruited at the chest pain unit at Sørlandet Hospital, Kristiansand, and will be recruited after they have finished their cardiac examination.
The intervention group will receive six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Cardiac Chest Pain
排除标准
- •Language difficulties
- •Unable to perform at least moderate physical activity due to physical constraints
- •Obvious cognitive impairment (e.g mentally retarded, psychotic, dementia or intoxicated)
- •no regular access to a computer/tablet computer with internet connection
结局指标
主要结局
Change in Body Sensations Questionnaire (BSQ)
时间窗: 58 weeks
BSQ is an 17-item self-report-questionnaire which measures fear of different bodily sensations. Each item is rated on a five-point Likert scale ranging from 1 to 5. Total range 17-85 where higher score represents more symptoms. Primary outcome is difference in mean score between intervention arm and control arm for BSQ at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). There is no predefined clinical relevant effect for this measure. The investigators will use a distribution based method. Clinical relevant effect is defined as improvement of more than 0.5 standard deviation compared to baseline.
次要结局
- Change in Cardiac Anxiety Questionnaire (CAQ)(58 weeks)
- Change in Brief Illness Perception Questionnaire (BIPQ)(58 weeks)
- Change in EQ-5D-5L(58 weeks)
- Change in self-developed questions(58 weeks)
- Change in Patient Health Questionnaire (PHQ-9)(58 weeks)