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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
Marburg, Germany
Change in depressive symptoms (BDI-II)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in heart rate variability
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in blood pressure
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in baroreceptor sensitivity (ms/mmHg)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in peripheral vascular resistance (dyne*s/cm5)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in C-reactive protein
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in proinflammatory cytokines
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in anti-inflammatory interleukin-10
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in Subjective social status (MacArthur scale)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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