Psychotherapy and Cardiovascular Risk Factors in Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35032
    • Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioral therapy; Cognitive behavioral therapy for Major Depression	Behavioral: Cognitive behavioral therapy
No Intervention: Waitlist group; Waitlist group to control for repeated physiological measures and fluctuations over time

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Frank Euteneuer, PhD, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; psychotherapy; cardiovascular health; psychoneuroimmunology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: DFG EU 154 2 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO