Depression Treatment and Risk for Cardiovascular Disease

East Carolina University0 个研究点目标入组 16 人2014年3月6日

适应症Depression

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Depression
发起方: East Carolina University
入组人数: 16
主要终点: Feasibility
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2014年3月6日

结束日期

2017年10月2日

最后更新

2年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

East Carolina University

责任方

Principal Investigator

主要研究者

Matthew Whited

Associate Professor of Psychology

East Carolina University

入排标准

入选标准

•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)

排除标准

•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.