E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Patient with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome often have high levels of stress and anxiety. At present there are no treatment alternatives in this group of patients. Previously, cognitive behavioral therapy (CBT), primarily aiming at relieving stress, has been shown to decrease morbidity in patient with myocardial infarction with obstructive coronary arteries. The present open randomized study aims to decrease stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome by an internet-based CBT focusing on stress and anxiety.
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
- 35 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%
- •age 35-80 years
- •admission-ECG with sinus rhythm
- •PSS-14 ≥ 25 and/or HADS-A ≥ 8 during admission
- •reading and writing proficiency in Swedish
- •computer/Internet access and literacy
排除标准
- •strong clinical suspicion of myocarditis
- •spontaneous coronary artery dissection
- •acute pulmonary embolism
- •acute myocardial infarction type 2
- •cardiomyopathy other than takotsubo syndrome
- •a previous myocardial infarction due to CAD
- •expected poor compliance to behavioural therapy
- •not likely to survive > one year due to for example cancer
结局指标
主要结局
Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)
时间窗: 12-14 weeks after the acute event
Normalisation of HADS-A (\<8 on a scale 0-21 with high numbers indicating increased anxiety)
Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)
时间窗: 12-14 weeks after the acute event
Normalisation of PSS-14 (\<25 on a scale 0-56 with high numbers indicating increased stress)
次要结局
- Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6)(10, 20 and 50 weeks after randomisation)
- Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)(10, 20 and 50 weeks after randomisation)
- Cortisol in hair(10 weeks after randomisation)
- Physiological recovery after stress determined by salivary cortisol(10 weeks after randomisation)
- Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ)(10, 20 and 50 weeks after randomisation)
- Sick leave(10, 20 and 50 weeks after randomisation)
- Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36)(10, 20 and 50 weeks after randomisation)
- Health-care visits(10, 20 and 50 weeks after randomisation)
- Physiological recovery after stress determined by Heart Rate Variability (HRV)(10 weeks after randomisation)
- Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)(10, 20 and 50 weeks after randomisation)
研究者
Per Tornvall
Professor
Karolinska Institutet