Depression Treatment and Risk for Cardiovascular Disease

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06170255

Enrollment

Registered

2023-12-14

Start date

2014-03-06

Completion date

2017-10-02

Last updated

2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

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.

Interventions

BEHAVIORALBehavioral Activation (BA)

Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility	2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)	Feasibility of the study including recruitment, enrollment, and retention rates

Secondary

Measure	Time frame	Description
Heart Rate Variability (HRV)	12 weeks	Change in HRV from enrollment to post-treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026