Depression Treatment and Risk for Cardiovascular Disease

NCT ID: NCT06170255

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-06

Study Completion Date

2017-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Depression treatment

Participants receive behavioral therapy for depression

Group Type EXPERIMENTAL

Behavioral Activation (BA)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Activation (BA)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

East Carolina University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matthew Whited

Associate Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5K23HL109620

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Post-TBI Depression
NCT00211835 COMPLETED NA