Depression
Conditions
Keywords
cognitive behavioral therapy, psychotherapy, cardiovascular health, psychoneuroimmunology
Brief summary
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.
Interventions
BEHAVIORALCognitive behavioral therapy
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 heart rate variability | 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 |
| Change in C-reactive protein | Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up |
Countries
Germany
Outcome results
None listed