Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico: A Pilot of a Mindfulness-based Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Rates of Recruitment and Retention
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility and acceptability of a 4-week mindfulness program among young women in Puerto Rico with elevated stress. The main questions it aims to answer are:
- how feasible and acceptable is a s a 4-week mindfulness program among participants with elevated stress
- what are the changes in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers
Participants will be asked to
- attend 4 weekly virtual sessions and daily mindfulness exercises at home
- complete online study questionnaires
详细描述
Cardiometabolic diseases among women in Puerto Rico. The 1.7 million women residing in Puerto Rico experience a great load of cardiometabolic diseases (i.e., adiposity, type 2 diabetes, hypertension, and hyperlipidemia). It is estimated that, among women in PR, the prevalence of overweight and obesity is 67.1%, hypertension 39.2%, hyperlipidemia 36.8%, and type 2 diabetes 16.3%, with estimates of obesity and type 2 diabetes being higher than in men. With cardiometabolic diseases driving the majority of deaths and disability in Puerto Rico -including women, the steep societal and individual cost of these diseases-particularly in the context of Puerto Rico's financial crisis, it is imperative to understand modifiable factors influencing women's cardiometabolic health and guide early prevention efforts.
Psychological well-being and cardiometabolic health. Psychological well-being has gained attention as a protective factor against cardiovascular disease. This is of particular importance to women in Puerto Rico as they report greater psychological distress than Puerto Rican men. The protective effect of psychological well-being on cardiometabolic health is believed to partially occur by buffering the effects of stress on health. This is of particular importance to women in Puerto Rico given that stress is detrimental to Latinx cardiometabolic health. Puerto Ricans in the mainland US have lower psychological well-being, as measured by optimism, than other Latinx heritage groups.
Mindfulness-based Stress reduction programs (MBSR). The high burden of cardiometabolic diseases among women in Puerto Rico, their disproportionate exposure to stressors, and potentially low psychological well-being highlight the need for effective behavioral interventions. The American Heart Association has issued a call to action for studies testing mindfulness-based interventions for cardiometabolic health. At its core, this program empowers participants to develop a profound awareness of the present moment, fostering a deeper understanding of their thoughts, emotions, and bodily sensations. Through mindfulness meditation and a series of carefully crafted exercises, MBSR equips individuals with powerful tools to manage stress, reduce anxiety, and enhance their overall well-being. MBSR consists of an 8-week program with weekly sessions (usually lasting 2.5 hours), daily practice exercises (of 45 minutes duration each), and an end-of-program day-long retreat. MBSR has been shown to improve psychological well-being, with studies documenting greater intervention effectiveness and acceptability for women than men. Additionally, studies have shown that mindfulness-based interventions reduce adiposity and hypertension. However, there is limited data on MBSR in Latinx women-less in Puerto Rico. The Puerto Rican population has unique socio-cultural values and norms that merit MBSR to be tested in this group.
MBSR interventions have critical pitfalls, such as time and transportation barriers, that need to be addressed to improve implementation. The only study in Puerto Rico evaluating an MBSR reported time commitment and lack of transportation as barriers to participation. A study done at UMass Medical School did some preliminary work to address these limitations. The researchers at UMass have adapted the original MBSR to use shortened weekly sessions (1.5- 1hr) and home practice exercises (5-15min). The researchers also selected 4 sessions out of the original 8-week MBSR sessions to shorten the program. This responds to preliminary data from our focus group discussions among young women in Puerto Rico documenting that an 8-week long program with weekly sessions was a burden and would hinder participation.
The Investigator took these modifications and further made adaptations to make the 4-week MBSR program be delivered virtually. The original 4-week protocol by Rosal and Camrody was already available in English and Spanish. In the present study, we will test the feasibility and acceptability of the Spanish version 4-week MBSR program among young women (18-29yr) with elevated stress residing in Puerto Rico and will explore changes in resilience, stress, health behavior, and cardiometabolic outcomes. Testing the Spanish 4-week MBSR protocol in young women in Puerto Rico is needed to evaluate novel strategies that may be feasible and acceptable for this group
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Individuals residing in Puerto Rico
- •Spanish speaking
- •Elevated stress (defined as a score >6 in the Perceived Stress Scale (PSS-4)34)
- •Willing to undergo research activities (focus group discussions).
排除标准
- •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)
- •Prisoners
- •Cognitively impaired or Individuals with Impaired Decision-Making Capacity
结局指标
主要结局
Rates of Recruitment and Retention
时间窗: Baseline, week 4, week 8
Number of participants at the beginning of the study versus the number of participants at the end of the study.
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
时间窗: 4 weeks
The frequency of self-reported completed home practice was assessed at post-intervention assessments. Participants will answer the question "Usually, how often did you practice the at-home exercises of the program?". Response options include: never, \<1/week 1-2/week, 3-4/week, 5-6/week, every day.
Adherence to the Program: Number of 4-week MBSR Sessions Joined
时间窗: 4 weeks
Measured by the number of sessions joined. This is tracked by session attendance done by research staff". Data entered will be 0 sessions, 1 session, 2 sessions, 3 sessions or 4 sessions
Ratings of Satisfaction (Overall)
时间窗: Week 4
Ratings of program satisfaction, also assessed by survey in post-intervention assessments, will be measured with aseveral questions on, including one that reads "Overall, how satisfied were you with the stress reduction program
Ratings of Satisfaction Pre and Post Intervention
时间窗: Baseline, week 4
Satisfaction with the ability to manage stress in life before and after the 4-week MBSR intervention
次要结局
- Change in Depression Symptoms: CSED-10 Scores(Baseline, week 4, 2 month follow up)
- Change in Anxiety Symptoms: GAD-7 Scores(Baseline, week 4, 2 month follow up)
- Change in PTSD Symptoms: Civilian Abbreviated Scale(Baseline, week 4, 2 month follow up)
- Change in Perceived Stress (Perceived Stress Scale)(Baseline, week 4, 2 month follow up)
- Shift-and-persist (Chen et al)(Baseline, week 4, 2 month follow up)
- Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)(Baseline, week 4, 2 month follow up)
- Change in Psychological Flexibility: Acceptance and Action Questionnaire - II(Baseline, week 4, 2 month follow up)
研究者
Andrea Lopez-Cepero
Professor
Emory University
