Safety and Efficacy of Cognitive Behavior Therapy for People With Post-traumatic Stress and Cardiovascular Illness
Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients
研究概览
地位
条件
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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Queens、New York、美国、11373
- Elmhurst Hospital Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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实验性的:Cognitive behavioral therapy (CBT)
Participants will receive cognitive behavioral therapy
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Participants meet with a therapist for three to five sessions brief exposure-based CBT.
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有源比较器:Educational session and treatment as usual
Participants will receive an educational session and treatment as usual
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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.
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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
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Measured at Months 2 and 6
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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)
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Measured at Months 2 and 6
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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.
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Measured at Months 2 and 6
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 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
研究美国 FDA 监管的设备产品
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