ClinicalTrials.Veeva

Menu

Depression Treatment and Risk for Cardiovascular Disease

U

University of North Carolina System

Status and phase

Completed
Phase 2
Phase 1

Conditions

Depression

Treatments

Behavioral: Behavioral Activation (BA)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06170255
5K23HL109620

Details and patient eligibility

About

This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.

Enrollment

16 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males and females age 21-75

Meet diagnostic criteria for major depressive disorder

Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.

Levels of depressive symptoms of at least moderate level (beck depression inventory II score > 19 of 63 possible points; or a Hamilton depression rating scale > 12 of 50 possible points)

Exclusion criteria

A verbal expression of current, significant, suicidal ideation; a score of > 15 on the beck scale for suicidal ideation

Score of >1 on any single item of the Beck Scale for Suicidal Ideation

Score of > 1 on the item assessing suicidal ideation on the beck depression inventory II.

Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)

Current use of an antidepressant medication

Currently in psychotherapy.

Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent

Diagnosis of CVD.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Depression treatment
Experimental group
Description:
Participants receive behavioral therapy for depression
Treatment:
Behavioral: Behavioral Activation (BA)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems