Early EEG-NF Intervention for the Prevention of PTSD in First Time ACS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Anxiety levels after 10 sessions of EEG-NF.
研究概览
简要总结
12% of patients suffering from an acute crornary syndrome will develop long lasting anxiety symptoms. The object of this study is to lessen or prevent these symptoms by the use of neurofeed back (EEG-NF).
详细描述
The accepted definition for a mentally traumatic event is an event in which there is a chance of death, severe injury or a severe threat to one's body (either as a victim or as an observer) and that event stimulates an intense emotional response of fear, horror or helplessness1. About forty percent of western population will undergo such an event during their life time, out of which up to thirty percent will suffer from a short live anxiety disorder and up to quarter will suffer from a chronic anxiety disorder (PTSD - Post Traumatic Stress Disorder) or depression2,3.
The distinction between different anxiety disorders is based on their time of appearance and how long they will last. The shortest disorder is the acute stress reaction (ASR) which appears immediately after the traumatic event and will disappear after 48 - 72 hours. ASR symptoms include dissociation, anxiety and affective instubility3. The medium range anxiety disorder is the acute stress disorder (ASD), which appears in the first two weeks following the event and will last up to a month. Its symptoms include dissociation, re-experiencing of the traumatic event and avoidant behavior of places and actions that might resemble the traumatic event. The long lasting disorder is the post traumatic stress disorder (PTSD), which lasts more than a month and includes symptoms of re-experiencing, avoidant behavior and hyper arousal1.
A recent meta analysis of studies on the prevalence of PTSD in patients suffering from an acute coronary syndrome (ACS) demonstrated that about 12% will develop PTSD (in some studies the prevalence was up to 32%). In three of the studies that were included, the morbidity and mortality stemming from the PTSD were examined and were twice as high compared to the patients without PTSD4.
The personal, social and financial toll of anxiety disorders is significant and still, to date, there is no excepted treatment that aims to prevent the occurrence of these disorders. A few studies on the subject have shown that early interventions (done in the days to weeks after the traumatic event) have an advantage in the prevention of PTSD, as opposed to immediate interventions (that show no benefit)5,6.
Due to the subjectivity of the experience of a traumatic event there is great difficulty in the prediction of who will develop an anxiety disorder. A few risk factors for the development of PTSD were suggested in different studies: female sex, minors, low socioeconomic status, young age, history of trauma, mental illness, little social support, the severity of the event and adrenergic hyperactivity following the event5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- 否
入选标准
- •First ACS.
- •Hemodynamic stable.
- •Underwent MRI scan clearance as accustomed in the Tel Aviv medical center.
- •The participation of a patient, who underwent an insertion of a coronary stent, will be allowed only if the stent maker cleared in writing the stent exposure to a magnetic field of 3 Tesla, and a written consent by the patients' cardiologist was supplied
排除标准
- •Patient does not speak Hebrew.
- •The patient is having chest pain.
- •History of psychiatric or neurologic condition requiring hospitalization.
- •Hemodynamic instability.
结局指标
主要结局
Anxiety levels after 10 sessions of EEG-NF.
时间窗: 2 to 4 weeks after complition of the meetings.
Patients will be assessed for thei anxiety levels, 2 to 4 weeks after completing 10 meetings of EEG-NF.
次要结局
未报告次要终点
