Clinical trial NCT02787148: Psychotherapy and Cardiovascular Risk Factors in Depression
Official title: The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: cognitive behavioral therapy
psychotherapy
cardiovascular health
psychoneuroimmunology
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Change in depressive symptoms (BDI-II)
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Secondary outcomes:
measure: Change in heart rate variability
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in blood pressure
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in baroreceptor sensitivity (ms/mmHg)
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in peripheral vascular resistance (dyne*s/cm5)
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in C-reactive protein
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in proinflammatory cytokines
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in anti-inflammatory interleukin-10
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
measure: Change in Subjective social status (MacArthur scale)
timeFrame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
Study officials:
affiliation: Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
name: Frank Euteneuer, PhD
role: PRINCIPAL_INVESTIGATOR
References: