Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychotherapy and Cardiovascular Risk Factors in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787148
Recruitment Status : Unknown
Verified June 2016 by Dr. rer. nat. Frank Euteneuer, Philipps University Marburg Medical Center.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. rer. nat. Frank Euteneuer, Philipps University Marburg Medical Center

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. One-hundred 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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive behavioral therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Study Start Date : October 2015
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Measures :
  1. Change in heart rate variability [ Time Frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up ]
  2. Change in blood pressure [ Time Frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up ]
  3. Change in baroreceptor sensitivity (ms/mmHg) [ Time Frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up ]
  4. 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 ]
  5. Change in C-reactive protein [ Time Frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up ]
  6. Change in proinflammatory cytokines [ Time Frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up ]
  7. Change in anti-inflammatory interleukin-10 [ Time Frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up ]
  8. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with Major Depression (DSM IV), BDI >=18
  • age:18-65 years
  • patients with and 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787148


Contacts
Layout table for location contacts
Contact: Frank Euteneuer, PhD 004964212823350 frank.euteneuer@staff.uni-marburg.de

Locations
Layout table for location information
Germany
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg Recruiting
Marburg, Germany, 35032
Contact: Frank Euteneuer, PhD    +49-6421-2823350    frank.euteneuer@staff.uni-marburg.de   
Sub-Investigator: Winfried Rief, PhD         
Principal Investigator: Frank Euteneuer, PhD         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Frank Euteneuer, PhD Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Layout table for additonal information
Responsible Party: Dr. rer. nat. Frank Euteneuer, PhD, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT02787148    
Other Study ID Numbers: DFG EU 154 2 1
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. rer. nat. Frank Euteneuer, Philipps University Marburg Medical Center:
cognitive behavioral therapy
psychotherapy
cardiovascular health
psychoneuroimmunology
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders