Implementation of a Short Mindfulness-based Program for Young Women in Puerto
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Rates of recruitment
研究概览
简要总结
The goal of this study is to evaluate the feasibility and acceptability of a revised 4-week mindfulness program among young women with elevated stress and anxiety in Puerto Rico
详细描述
Women in Puerto Rico (PR) experience a high prevalence of cardiometabolic diseases (CMD), with 38% affected by obesity and 42% by hypertension. These rates are higher than those observed in PR men and non-Latinx White women in the continental U.S. Chronic stress is a key risk factor for CMD, and PR women report higher psychological distress than men, despite facing similar social and environmental stressors. Young adult women are particularly vulnerable, as stress during this life stage can shape long-term health outcomes, highlighting the need for targeted interventions.
Mindfulness-Based Stress Reduction (MBSR) is a structured, evidence-based program designed to reduce stress through techniques such as focused attention, open monitoring, and non-judgmental awareness. MBSR has been shown to lower blood pressure, improve heart rate variability (HRV), and reduce psychological distress, including anxiety and depression. The program's emphasis on group sessions aligns well with PR's collectivist culture, making it a potentially effective approach for this population. However, traditional MBSR programs, which span eight weeks with long session durations and extensive home practice, pose feasibility challenges, particularly in PR, where transportation and time constraints are significant barriers.
To overcome these limitations, researchers have adopted a 4-week MBSR program tailored specifically for young PR women, using shorter sessions and telehealth delivery. Preliminary research has demonstrated good participant retention, satisfaction, and improvements in psychological distress among Latinx women, but no randomized controlled trials (RCTs) have been conducted to evaluate MBSR's impact on PR women's cardiometabolic health. The proposed pilot RCT aims to address this gap by testing the feasibility, acceptability, and effectiveness of the adapted 4-week MBSR program, providing a culturally relevant intervention to reduce stress and improve CMD outcomes in this underserved group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reporting female sex at birth
- •Not identifying as a man, trans man, or trans woman.
- •Individuals residing in Puerto Rico
- •Spanish speaking
- •Currently not pregnant
- •Elevated stress (defined as a score >6 in the Perceived Stress Scale (PSS-4)34) or Elevated anxiety (defined as a score of 5 or more on the GAD-7 scale)
- •Willing to undergo research activities.
排除标准
- •Male sex at birth
- •Identifying as a man, trans man, or trans woman.
- •Currently pregnant
- •Previous participation in an 8-week MBSR program
- •Experiencing moderately severe or severe depressive symptoms (PHQ-9>15)35)
- •Have active suicidal ideation (PHQ-9 item #9)35
- •Self-report history of cognitive and psychiatric conditions
- •Lack of access to the internet/phone (mode of focus group discussions-via Zoom)
研究组 & 干预措施
MBSR: Mindfulness-based stress reduction
- 4-week intervention (1 weekly virtual session; daily mindfulness exercises at home)
- 3 study assessments (baseline, post-intervention, 1 month post-intervention)
干预措施: Mindfulness-based stress reduction :MBSR (Behavioral)
Usual care group
Placebo Comparator: Usual care group
- No intervention, but participants will have access to audio files and a mindfulness information sheet after study completion
- 3 study assessments (baseline, 1 mo, 2mo)
干预措施: Usual care (Behavioral)
结局指标
主要结局
Rates of recruitment
时间窗: Baseline
Number of participants approached for the study versus number of participants that are enrolled.
Rates of retention
时间窗: Baseline, 2 months follow up
Number of participants at the beginning of the study versus the number of participants at the end of the study.
Rates of adherence
时间窗: Post intervention (1-month), 2-month follow up
Adherence will be measured by the number of phone sessions attended and the frequency of self-reported completed home practice, both assessed at post-intervention assessments.
Rates of satisfaction
时间窗: Post intervention (1 month), 2 months follow up
Ratings of satisfaction, also assessed by client satisfaction questionnaire (CSQ-8) in post-intervention assessments, will be measured with several questions, including one that reads "Overall, how satisfied were you with the stress reduction program", "How satisfied are you now (after the stress reduction program) with your ability to manage the stress in your life?", and "How much did the program helped you manage your stress?
次要结局
- Change in Depression symptoms(Baseline, Post intervention (1 month), 2 months follow up)
- Change in Anxiety (GAD-& score)(Baseline, Post intervention (1 month), 2 months follow up)
- Change in PTSD symptoms(Baseline, Post intervention (1 month), 2 months follow up)
- Change in blood pressure(Baseline, Post intervention (1 month), 2 months follow up)
- Change in perceived symptoms(Baseline, Post intervention (1 month), 2 months follow up)
- Change in adiposity(Baseline, Post intervention (1 month), 2 months follow up)
- Heart rate variability (HRV)(Baseline, Post intervention (1 month), 2 months follow up)
研究者
Andrea Lopez-Cepero
Assistant Professor
Emory University