Psychotherapy and Cardiovascular Risk Factors in Depression

NCT ID: NCT02787148

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive behavioral therapy

Cognitive behavioral therapy for Major Depression

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

Waitlist group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Dr. rer. nat. Frank Euteneuer

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Euteneuer, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg

Locations

Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Marburg, , Germany

Countries

Germany

Other Identifiers

DFG EU 154 2 1

Identifier Type: -

Identifier Source: org_study_id