Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors: A Six-Week Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Lipids from baseline
研究概览
简要总结
This project evaluates the effectiveness of an intervention sought to reduce the physical effects of stress related to those issues that individuals cannot successfully communicate with anyone about. To do this, the investigators will be implementing a writing intervention over the course of the 6-week study. The investigators will be asking all participants to complete questionnaires over the course of the study period. The investigators are also asking participants to provide a small blood sample (from a fingerstick procedure) at two times during the study as well as saliva samples during that same time. The primary research question asks if this intervention procedure is effective. The investigators are evaluating total cholesterol, high sensitivity c-reactive protein, and cortisol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •110 pounds in weight
- •Ability to fast for 8 hours prior to laboratory visit
- •Staff member at Santa Clara University
- •Certain level of inclusionary pretest stress measure
排除标准
- •Hepatitis
- •Endocrine Disease
- •Kidney or Liver Disease
- •Cancer (in any form)
- •Cushing's disorder
- •Rheumatological disorders
- •Respiratory Disorders
- •High blood pressure
- •Low blood pressure
- •Heart or cardiovascular problems
- •Chemotherapy
- •Current use of alpha or beta blockers, steroids, or hormone replacements
- •Pregnant and/or breastfeeding mothers
结局指标
主要结局
Change in Lipids from baseline
时间窗: Week 1 and Week 6
Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.
Change in high-sensitivity c-Reactive Protein from baseline
时间窗: Week 1 and Week 6
Change in Cortisol Awakening Response from Baseline
时间窗: Week 1 and Week 6
Measurement of Salivary Cortisol (hydrocortisone, compound-F) as a maximum difference between awakening and 30 minutes after awakening.
次要结局
- Change in Perceived Global Stress over time(Week 1, Week 3, Week 6)
- Change in Organizational Stress over time(Week 1, Week 3, Week 6)
- Change in Perception of Communication Restriction of Stressor over time(Week 1, Week 3, Week 6)
研究者
Justin P. Boren
Assistant Professor
Santa Clara University