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
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10029
- Icahn School of Medicine at Mount Sinai
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Queens, New York, Соединенные Штаты, 11373
- Elmhurst Hospital Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Cognitive behavioral therapy (CBT)
Participants will receive cognitive behavioral therapy
|
Participants meet with a therapist for three to five sessions brief exposure-based CBT.
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|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Average blood pressure
Временное ограничение: Measured at Months 2 and 6
|
Measured at Months 2 and 6
|
|
|
Impact of Event Scales (IES)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Beck Depression Inventory (BDI)
Временное ограничение: 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
|
Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GCO 03-0985
- R34MH071249 (Грант/контракт NIH США)
- 03-0985 DAHBR 96-BHC
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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