Depression Treatment and Risk for Cardiovascular Disease

Phase 1

Completed

• Conditions: Depression
• Interventions: Behavioral: Behavioral Activation (BA)

• Registration Number: NCT06170255
• Lead Sponsor: East Carolina University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Primary Completion: 2017-10-02
• Study Completion: 2017-10-02
• Study First Submitted: 2023-11-17
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Depression treatment	Behavioral Activation (BA)	Participants receive behavioral therapy for depression

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Heart Rate Variability (HRV)	12 weeks	Change in HRV from enrollment to post-treatment