Psychotherapy and Cardiovascular Risk Factors in Depression

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy<br>Cognitive behavioral therapy for Major Depression | Behavioral: Cognitive behavioral therapy<br> <br> |
| No Intervention: Waitlist group<br>Waitlist group to control for repeated physiological measures and fluctuations over time | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms (BDI-II) |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate variability |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in blood pressure |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in baroreceptor sensitivity (ms/mmHg) |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in peripheral vascular resistance (dyne*s/cm5) |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in C-reactive protein |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in proinflammatory cytokines |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in anti-inflammatory interleukin-10 |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 
| Change in Subjective social status (MacArthur scale) |  | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy, psychotherapy, cardiovascular health, psychoneuroimmunology