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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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Queens, New York, Estados Unidos, 11373
- Elmhurst Hospital Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average blood pressure
Periodo de tiempo: 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)
Periodo de tiempo: Measured at Months 2 and 6
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Beck Depression Inventory (BDI)
Periodo de tiempo: Measured at Months 2 and 6
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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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GCO 03-0985
- R34MH071249 (Subvención/contrato del NIH de EE. UU.)
- 03-0985 DAHBR 96-BHC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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