Psychotherapy and Cardiovascular Risk Factors in Depression
The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.
The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Marburg, Alemania, 35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
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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:
- patients with Major Depression (DSM IV), BDI >=14
- age:18-65 years
- patients without antidepressive medication (stable for at least 2 weeks)
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
Exclusion Criteria:
- current psychotherapy
- psychotic disorder
- serious drug-addiction
- drugs which seriously affect immune status (except contraceptives) or central
- nervous system functions (except antidepressants)
- infections during the last 2 weeks
- injuries during the last 2 weeks
- neurological disorders
- diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cognitive behavioral therapy
Cognitive behavioral therapy for Major Depression
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Sin intervención: Waitlist group
Waitlist group to control for repeated physiological measures and fluctuations over time
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in depressive symptoms (BDI-II)
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in heart rate variability
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in blood pressure
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in baroreceptor sensitivity (ms/mmHg)
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in peripheral vascular resistance (dyne*s/cm5)
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in C-reactive protein
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in proinflammatory cytokines
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in anti-inflammatory interleukin-10
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in Subjective social status (MacArthur scale)
Periodo de tiempo: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Frank Euteneuer, PhD, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DFG EU 154 2 1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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