Implementation of a Short Mindfulness-based Program for Young Women in Puerto Rico
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-based stress reduction :MBSR, Usual care.
- Who it may be relevant to
- Registry conditions: Stress, Anxiety. Basic parameters: 18 years — 29 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of a Short Mindfulness-based Program for Young Women in Puerto
Overview
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.
Interventions
- 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, - 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
Primary outcome measures
- Rates of recruitment [Time frame: Baseline]
- Rates of retention [Time frame: Baseline, 2 months follow up]
- Rates of adherence [Time frame: Post intervention (1-month), 2-month follow up]
- Rates of satisfaction [Time frame: Post intervention (1 month), 2 months follow up]
Secondary outcome measures (7)
- Change in Depression symptoms [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
- Change in Anxiety (GAD-& score) [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
- Change in PTSD symptoms [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
- Change in perceived symptoms [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
- Change in blood pressure [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
- Change in adiposity [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
- Heart rate variability (HRV) [Time frame: Baseline, Post intervention (1 month), 2 months follow up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06909526 · STUDY00007906