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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy for Major Depression |
|
| Waitlist group | No Intervention | Waitlist group to control for repeated physiological measures and fluctuations over time |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Euteneuer, PhD | Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Psychology and Psychotherapy, Philipps University Marburg | Marburg | 35032 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |