Stress, the HPA and Health in Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in depression
研究概览
简要总结
The purpose of this study is to determine if improvements in mood will ameliorate autonomic dysregulation, HPA dysfunction and typical (e.g. lipids) and atypical risk factors in depressed patients with elevated cardiovascular risk (CVD). Up to 70, depressed participants with elevated cardiovascular risk factors were randomized to a cognitive behavioral intervention (CBT) or a waiting list control (WLC) condition. Twenty non-depressed age and risk-matched controls will also recruited. Traditional risk factors (e.g. lipids, blood pressure, heart rate), atypical risk factors (endothelial function, asymmetric dimethylarginine, C-reactive protein) will be measured pre and post treatment six months later Subjects will undergo a psychophysiological stress test while cardiovascular physiology was measured. Salivary cortisol will be measured during the day and during the psychological stress test. Depressed subjects will be randomized to a 16 week cognitive behavior therapy intervention or to a wait-list control. It is hypothesized that reduction in mood will be associated with reduction in typical and atypical risk factors.
详细描述
Recruitment:
The sample will be drawn from the following Stanford Health Services clinics: the Stanford Cardiovascular Risk Reduction Clinic, the Electron Beam Computed Tomography Center, and the Cardiology Clinics. Subjects will also be recruited via the mass media.
Screen:
Potential subjects will be identified by a brief screen combined with a short follow-up interview, the PRIME-MD that consists of two self-report items, as follows: "During the PAST MONTH, have you been bothered A LOT by (1) little interest or pleasure in doing things (yes or no) or (2) feeling down, depressed, or hopeless (yes or no)." If either item is scored "yes," a short follow-up interview to establish a diagnosis is indicated. The two screen items yield a sensitivity of 69% and specificity of 82% when diagnoses made by a mental health professional are used as the criterion standard. Subjects will also have to have a general health questionnaire score > 5, indicating high levels of distress. Potentially eligible subjects will then undergo a structured clinical interview for diagnosis. Twenty, age, gender and cardiovascular risk level controls will be selected from the same population. Controls will be matched for age, sex and risk with the depressed subjects.
Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 55 years, hypertensive or hypercholesterolemic, depressed
排除标准
- 未提供
结局指标
主要结局
Change in depression
次要结局
- Change in typical and atypical risk factors