Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Patients in the CBT intervention arm will have a higher reduction in anxiety and experience better quality of life compared to usual care at 3 months.
研究概览
简要总结
This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing the amount of anxiety, as well as the number of inappropriate firings that a patient with an ICD may experience.
详细描述
This study is an interventional study of patients with ICDs followed in the Cleveland Clinic Device Clinic. Patients with ICDs experience some level of anxiety which can impact the number of shocks that they receive from their Device. 100 of these patients will be randomized into one of 2 groups; those receiving three sessions of Cognitive Behavioral Therapy (CBT) and those receiving usual care. We hypothesize that if these ICD patients receive short term (CBT) they will experience less anxiety and have a lower rate of device firings than the patients that did not receive CBT. Furthermore, we will study mechanistic pathways involved in the reduction of anxiety in ICD patients. We will extract initial heart rate variability (HRV) data from device interrogation. We hypothesize that the CBT intervention arm will have a higher normalization of HRV. Patients will repeat questionnaires at 3, 6 and 12 months.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently has an Implantable Cardioverter Defibrillator (ICD)
- •Experiences moderate to high anxiety as demonstrated by the the scores on the questionnaires that will be administered
排除标准
- •Unwilling to comply with follow-up requirements at 3, 6 and 12 months.
研究组 & 干预措施
Cognitive Behavioral Therapy
Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period
干预措施: Cognitive Behavioral Therapy (Behavioral)
Usual Care Arm
The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.
结局指标
主要结局
Patients in the CBT intervention arm will have a higher reduction in anxiety and experience better quality of life compared to usual care at 3 months.
时间窗: Patients in the CBT arm will have (3) 45min. sessions scheduled over a 3 month period.
次要结局
- Patients in the CBT intervention arm will have a lower rate of firings (shocks).(Patients in both arms will have their ICD's interrogated at 3, 6 and 9 months.)