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临床试验/NCT06170255
NCT06170255
已完成
1 期

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

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

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.

结局指标

主要结局

Feasibility

时间窗: 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

次要结局

  • Heart Rate Variability (HRV)(12 weeks)

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