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Psychotherapy and Cardiovascular Risk Factors in Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring cognitive behavioral therapy, psychotherapy, cardiovascular health, psychoneuroimmunology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive behavioral therapy

Waitlist group

Arm Description

Cognitive behavioral therapy for Major Depression

Waitlist group to control for repeated physiological measures and fluctuations over time

Outcomes

Primary Outcome Measures

Change in depressive symptoms (BDI-II)

Secondary Outcome Measures

Change in heart rate variability
Change in blood pressure
Change in baroreceptor sensitivity (ms/mmHg)
Change in peripheral vascular resistance (dyne*s/cm5)
Change in C-reactive protein
Change in proinflammatory cytokines
Change in anti-inflammatory interleukin-10
Change in Subjective social status (MacArthur scale)

Full Information

First Posted
February 10, 2016
Last Updated
July 21, 2021
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02787148
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
cognitive behavioral therapy, psychotherapy, cardiovascular health, psychoneuroimmunology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy for Major Depression
Arm Title
Waitlist group
Arm Type
No Intervention
Arm Description
Waitlist group to control for repeated physiological measures and fluctuations over time
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Change in depressive symptoms (BDI-II)
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Secondary Outcome Measure Information:
Title
Change in heart rate variability
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in blood pressure
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in baroreceptor sensitivity (ms/mmHg)
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in peripheral vascular resistance (dyne*s/cm5)
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in C-reactive protein
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in proinflammatory cytokines
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in anti-inflammatory interleukin-10
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Title
Change in Subjective social status (MacArthur scale)
Time Frame
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Euteneuer, PhD
Organizational Affiliation
Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychotherapy and Cardiovascular Risk Factors in Depression

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