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Completed

NCT Number: NCT02787148

Psychotherapy and Cardiovascular Risk Factors in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Marburg, 35032, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2016
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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