Stress Management to Support Women's Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
The purpose of this study is to evaluate a mindfulness-based cognitive therapy intervention delivered over the phone (MBCT-T) for women with prehypertension. MBCT-T is an evidence-based program that teaches meditation practices and cognitive strategies to reduce stress and negative emotions. It targets psychosocial risk factors that disproportionately affect women, including rumination (i.e., negative thinking) and low social support. Investigators plan to translate the established MBCT-T program into Spanish, conduct focus groups to inform cultural adaptations that may be needed for Latina women, and run a pilot randomized controlled trial to test the feasibility, acceptability and effects of MBCT-T on blood pressure and perceived stress in diverse women with prehypertension.
详细描述
Chronic stress is associated with the development of hypertension and cardiovascular disease. Reducing stress may be a useful prevention strategy for people at elevated risk of hypertension, including those with prehypertension. Women report different types of stress than men and may need tailored stress management programs.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English- or Spanish-speaking
- •A current patient of NYU/Bellevue Hospital Center (BHC) for the NYU study site or San Ysidro Health Center (SYHC) for the UCSD study site
- •BP measurement in prehypertensive range (SBP 120-139 mmHg or DBP 80-89 mmHg) recorded in EHR within past 6 months AND BP in prehypertensive range at screening
- •Willing to provide informed consent and comply with all aspects of the protocol
- •Willing to be audio-taped
排除标准
- •Current use of antihypertensive medication
- •Clinically significant depressive symptoms (PHQ-8 ≥10)
- •Significant cognitive impairment, in the EHR or apparent during screening
- •History of current diagnosis of schizophrenia or other psychotic disorders
- •Current participation in another clinical trial
结局指标
主要结局
Blood pressure
时间窗: 3 Months
The mean of three BP readings taken by a trained RA with an automated and validated BP monitor (Microlife WatchBP Office) will be recorded at each visit. Participants will be seated comfortably for 5 minutes with feet flat on the ground prior to measurements. The device will take three readings at 2-minute intervals.
次要结局
- Perceived stress(3 Months)
- Measure of Depressive Symptoms using the PHQ-8(3 Months)