Psychotherapy and Cardiovascular Risk Factors in Depression

Philipps University

Status

Completed

Conditions

Depression

Treatments

Behavioral: Cognitive behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02787148

DFG EU 154 2 1

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.)