Psychotherapy and Cardiovascular Risk Factors in Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787148
• Other study ID #: DFG EU 154 2 1
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: July 2021
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Cognitive behavioral therapy

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy, Philipps University Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

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