跳至主要内容
临床试验/NCT06811896
NCT06811896招募中不适用

Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Change in blood pressure at baseline, week 8, and week 20

研究概览

简要总结

Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Other
盲法
None

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

  • •cis-gender females at least 18 years of age
  • •HIV-seropositive and a patient of the recruiting clinic
  • •English speaking

排除标准

  • •severe mental illness
  • •not being willing able to provide informed consent
  • •not willing or able to attend study visits

研究组 & 干预措施

Control

Other

Usual Care

干预措施: Usual Care (Other)

Intervention

Other

Adapted Intervention, Previously Established

干预措施: Stress Management and Resiliency Training Program (Behavioral)

结局指标

主要结局

Change in blood pressure at baseline, week 8, and week 20

时间窗: baseline - week 8 - week 20

Measure blood pressure at baseline, end of intervention, and at 12-week follow-up

Change in Center for Epidemiological Studies Depression Scale Score

时间窗: baseline - week 8 - week 20

Higher score indicates more depressive symptoms (0-60 Range)

Change in Generalized Anxiety Disorder-7 Scale Score

时间窗: baseline - week 8 - week 20

Higher scores indicate greater symptoms of anxiety (0-21 Range)

Changes in Perceived Stress Scale Scores

时间窗: baseline - week 8 - week 20

Higher scores indicate greater perceived stress (0 - 40 Range)

Changes in Connor-Davidson Resilience Scale

时间窗: baseline - week 8 - week 20

Higher scores indicate greater resilience (0-100 Range)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenni Wise

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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