此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Efficacy of Cognitive Behavior Therapy for People With Post-traumatic Stress and Cardiovascular Illness

2017年12月21日 更新者:Icahn School of Medicine at Mount Sinai

Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients

This study will evaluate the safety and efficacy of cognitive behavioral therapy in treating people who are experiencing post-traumatic stress disorder after a heart attack.

研究概览

详细说明

PTSD usually develops in people who have experienced a traumatic or life-threatening event, including a health scare like a heart attack or catheterization. Symptoms of PTSD typically include anxiety, anger, and flashbacks or nightmares. PTSD symptoms are also associated with poor medical outcomes and nonadherence to medication after a heart attack. Fortunately, PTSD can sometimes be treated by antidepressants, anti-anxiety medication, and talk therapy. This study will compare the efficacy of cognitive-behavioral therapy (CBT) versus education and treatment as usual for treating people who are experiencing PTSD that is related to their cardiovascular illness (a heart attack or an invasive procedure such as catheterization).

Participants in this single-blind study will receive a psychiatric evaluation during which post-traumatic symptoms and feelings regarding their cardiovascular illness will be evaluated. Participants will then be randomly assigned to receive either CBT or a single educational session about PTSD, with up to 2 more follow-up educational meetings if needed. Participants assigned to the educational session will attend one meeting with a researcher to discuss the results from their evaluation. If they choose, they will also be referred to a mental health clinic for further care. Participants assigned to receive CBT will meet with a therapist once a week for at least 3 weeks. Participants will be offered the chance to meet with their therapist for two additional sessions if they need more time to discuss their symptoms. All participants will be re-evaluated at Months 2 and 6 using an interview, questionnaires,blood tests, blood pressure readings, and weight measurements.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai
      • Queens、New York、美国、11373
        • Elmhurst Hospital Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Suffered an acute heart attack or invasive treatment procedure related to a cardiovascular illness within 2 to 12 months of study entry
  • Meets the threshold PTSD screening criterion
  • Prescribed an anticoagulant or anti-aggregant at least 2 weeks prior to study entry

Exclusion Criteria:

  • Readmitted to the hospital due to cardiovascular complications within 2 months of study entry
  • Medically unstable
  • Not prescribed aspirin
  • Does not identify an event related to the cardiovascular illness as the primary trauma
  • Cannot take care of self and is dependent on a caretaker for adherence to medications or clinic visits
  • Suffers from other medical illnesses, including diseases that cause significant cognitive impairment (e.g., severe Alzheimer's), diseases that cause severe psychotic symptoms leading to disorientation (e.g., hepatic encephalopathy), diseases that cause brittle and uncontrollable blood pressure (e.g., pheochromocytoma), and diseases that cause uncontrollable hypercholesterolemia (e.g., severe familial hypercholesterolemia)
  • Suicidal or history of suicide attempt
  • Psychotic or suffers from a psychotic spectrum disorder
  • Receiving psychotropic medications or psychotherapy and changed dosage or frequency of treatment within 2 weeks of study entry
  • Currently receiving CBT

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cognitive behavioral therapy (CBT)
Participants will receive cognitive behavioral therapy
Participants meet with a therapist for three to five sessions brief exposure-based CBT.
有源比较器:Educational session and treatment as usual
Participants will receive an educational session and treatment as usual
Participants assigned to the educational session attend one meeting with a researcher to discuss the results from their evaluation. They could also be referred to a mental health clinic of their choice to help relieve their symptoms.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Average blood pressure
大体时间:Measured at Months 2 and 6
Measured at Months 2 and 6
Impact of Event Scales (IES)
大体时间:Measured at Months 2 and 6
A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)
Measured at Months 2 and 6

次要结果测量

结果测量
措施说明
大体时间
Beck Depression Inventory (BDI)
大体时间:Measured at Months 2 and 6
a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Measured at Months 2 and 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年4月1日

初级完成 (实际的)

2008年4月1日

研究完成 (实际的)

2008年4月1日

研究注册日期

首次提交

2006年8月15日

首先提交符合 QC 标准的

2006年8月15日

首次发布 (估计)

2006年8月16日

研究记录更新

最后更新发布 (实际的)

2017年12月26日

上次提交的符合 QC 标准的更新

2017年12月21日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • GCO 03-0985
  • R34MH071249 (美国 NIH 拨款/合同)
  • 03-0985 DAHBR 96-BHC

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅