Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico

Not Applicable

Completed

Conditions: Psychological Distress
Cardiometabolic Syndrome

Interventions: Behavioral: Home exercises

Registration Number: NCT06250738

Lead Sponsor: Emory University

Brief Summary: 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

Detailed Description: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 24

Inclusion Criteria

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).

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	Home exercises	-

Primary Outcome Measures

Name	Time	Method
Rates of Recruitment and Retention	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	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	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)	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	Baseline, week 4	Satisfaction with the ability to manage stress in life before and after the 4-week MBSR intervention

Secondary Outcome Measures

Name	Time	Method
Change in Depression Symptoms: CSED-10 Scores	Baseline, week 4, 2 month follow up	The CESD-10 is a shortened version of the 20-item CES-D, designed to assess depressive symptoms. It includes 10 questions rated on a 4-point Likert scale (0-3), with higher scores indicating greater symptom severity. The scale covers both negative (e.g., loneliness, sadness) and positive (e.g., hopefulness, happiness) experiences. A total score ranges from 0 to 30, with a score of 10 or higher often indicating significant depressive symptoms and a potential risk for Major Depressive Disorder (MDD).
Change in Anxiety Symptoms: GAD-7 Scores	Baseline, week 4, 2 month follow up	The GAD-7 is a seven-item screening tool for generalized anxiety disorder. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, with 10 or higher suggesting possible GAD. Severity levels range from minimal (0-4) to severe (15-21).
Change in PTSD Symptoms: Civilian Abbreviated Scale	Baseline, week 4, 2 month follow up	Two symptoms of PTSD experienced in the previous month were assessed with the PTSD Civilian Abbreviated Scale. One item measured disturbing memories of any adverse event, and the second item measured feelings of distress due to these memories. Response options to both items were on a 5-point scale and ranged from 0 'not at all' to 4 'extremely'. Response options to both items were summed (Lowest score: 0, highest score: 8), with higher scores indicating greater PTSD symptomatology.
Change in Perceived Stress (Perceived Stress Scale)	Baseline, week 4, 2 month follow up	The PSS-4 is a short tool measuring perceived stress based on feelings of unpredictability and overwhelm. Scores range from 0 to 16, with higher scores indicating greater stress.
Shift-and-persist (Chen et al)	Baseline, week 4, 2 month follow up	It includes 8 items: 4 measuring shift and 4 measuring persist. Response options for all items were on a 4-point Likert scale (from a score of 1 for 'not at all' to a score of 4 for 'a lot'). Total scores were calculated by summing each subscale's items, and possible scores range from 8 to 32, with higher scores indicating greater shift and persist
Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)	Baseline, week 4, 2 month follow up	The FFMQ-15 is a 15-item tool assessing mindfulness across five dimensions: observing, describing, awareness, non-judging, and non-reacting. Higher scores indicate greater mindfulness, linked to better emotional regulation and well-being. Average scores are obtained by adding up the responses and dividing by the total number of items, reflecting the overall agreement with each item (1 = rarely true, 5 = always true). Higher scores suggest a greater level of mindfulness in daily life.
Change in Psychological Flexibility: Acceptance and Action Questionnaire - II	Baseline, week 4, 2 month follow up	The AAQ-II measures psychological flexibility, or the ability to accept negative emotions and take value-driven actions. Higher scores indicate greater flexibility, associated with better emotional resilience and well-being. Includes seven statements that participants rate using a 7-point Likert scale, from 1 ("Never true") to 7 ("Always true"). The total score is obtained by adding the ratings for all items (ranging from 7- 49). Higher scores reflect lower psychological flexibility, whereas lower scores indicate greater flexibility

Trial Locations

Locations (1): Rollins School of Public Helath
🇺🇸
Atlanta, Georgia, United States
Rollins School of Public Helath
🇺🇸Atlanta, Georgia, United States