Psychotherapy and Cardiovascular Risk Factors in Depression

NCT02787148 | Completed

• 1 other identifier: DFG EU 154 2 1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

cognitive behavioral therapy; psychotherapy; cardiovascular health; psychoneuroimmunology

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms (BDI-II)

  Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up

Secondary Outcomes (8)

• 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

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

Cognitive behavioral therapy for Major Depression

Behavioral: Cognitive behavioral therapy

Waitlist group

NO INTERVENTION

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

Interventions

Cognitive behavioral therapy BEHAVIORAL

Cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Marburg, 35032, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Frank Euteneuer, PhD

  Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: June 1, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)