Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Impact of Event Scales (IES)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive behavioral therapy (CBT)
Participants will receive cognitive behavioral therapy
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
Educational session and treatment as usual
Participants will receive an educational session and treatment as usual
干预措施: Educational session and treatment as usual (Behavioral)
结局指标
主要结局
Impact of Event Scales (IES)
时间窗: 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)
Average blood pressure
时间窗: Measured at Months 2 and 6
次要结局
- Beck Depression Inventory (BDI)(Measured at Months 2 and 6)