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临床试验/NCT03336112
NCT03336112已完成不适用

Internet-delivered Cognitive Behavioral Therapy for Treatment of Cardiac Anxiety in Patients With Non-cardiac Chest Pain - a Randomized Controlled Study

Linkoeping University1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
Cardiac anxiety

研究概览

简要总结

Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out', many patients think they have an undetected cardiac disease (i.e. they suffer cardiac anxiety) as no other explanation is offered. They therefore avoid activities that they believe might be harmful to their heart, leading to greater ill-health, and increased healthcare use and societal costs. Targeting cardiac anxiety with psychological interventions might break this vicious circle and improve patient outcomes. Patients need to evaluate the way they perceive and handle their chest pain, which can be done with cognitive behavioral therapy (CBT).

The aim of this study is therefore to evaluate the short- and long-term effects of an Internet-delivered CBT (I-CBT) program on psychological distress and other patient-reported outcomes in patients with NCCP. A second aim is to explore factors related to implementation of I-CBT in clinical care. The study has a randomized controlled design comparing I-CBT with Internet-delivered information program. Quantitative methods will be used to evaluate the effectiveness of the I-CBT program. Implementation issues will be evaluated from the perspectives of patients, healthcare professionals and policymakers using qualitative methods.

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

入选标准

  • at least 2 healthcare visits due to NCCP during the last 6 months
  • patients suffering from cardiac anxiety (score ≥ 24 on the Cardiac Anxiety Questionnaire-CAQ)

排除标准

  • language difficulties
  • not able to perform physical activity/exercise due to physical constraints
  • patients with severe depressive symptoms
  • patients with acute ischemic heart disease
  • patients with no access to computer/tablet and/or Internet

结局指标

主要结局

Cardiac anxiety

时间窗: 12 months after end of intervention

Cardiac Anxiety Questionnaire (CAQ) will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes related to intervention. The CAQ consists of 18 items and a score range between 0 and 72. The higher scores the greater cardiac anxiety.

次要结局

  • Fear of body sensations(12 months after end of intervention)
  • Depressive symptoms(12 months after end of intervention)
  • Health-related quality of life(12 months after end of intervention)
  • Chest pain frequency(12 months after end of intervention)
  • Societal costs(12 months after end of intervention)
  • Healthcare use(12 months after end of intervention)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ghassan Mourad

Senior lecturer

Linkoeping University

研究点 (1)

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