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Completed

NCT Number: NCT06170255

Depression Treatment and Risk for Cardiovascular Disease

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Activation (BA)

Behavioral

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

Primary outcomes

  1. Feasibility

    Time frame: 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 outcomes

  1. Heart Rate Variability (HRV)

    Time frame: 12 weeks

    Change in HRV from enrollment to post-treatment

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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