NCT06170255已完成1 期
Depression Treatment and Risk for Cardiovascular Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Feasibility
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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)
研究者
Matthew Whited
Associate Professor of Psychology
East Carolina University
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