NCT06909526

Implementation of a Short Mindfulness-based Program for Young Women in Puerto Rico

Implementation of a Short Mindfulness-based Program for Young Women in Puerto

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Stress
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-based stress reduction :MBSR	The intervention consists of 4 weekly virtual sessions and daily mindfulness exercises at home (between 1-5min of duration each, according to the participant's availability. Each session lasts 1 hour (except the first one, which is 1.5 hours due to discussion of the program's logistics). The sessions follow a brief check-in, a lecture on the week's topic, and a guided practice exercise. For the audio guides, participants can select a short version of the daily practice exercise or a longer one, which they will record in the practice logs. Participants also receive information sheets summarizing the weekly sessions.
BEHAVIORAL	Usual care	Subjects will continue with their usual healthcare routine and lifestyle. Upon completion of all study visits, subjects will be given access to the audio guides and information sheets for voluntary at-home practice exercises

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-04-03
• Last updated: 2025-04-17