Clinical trial NCT06909526: Implementation of a Short Mindfulness-based Program for Young Women in Puerto Rico
Official title: Implementation of a Short Mindfulness-based Program for Young Women in Puerto
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Keywords: Stress in women
Anxiety in women
Mindfullness
Mindfulness-based stress reduction
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2025-04-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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)

Primary outcomes:
measure: Rates of recruitment
timeFrame: Baseline
measure: Rates of retention
timeFrame: Baseline, 2 months follow up
measure: Rates of adherence
timeFrame: Post intervention (1-month), 2-month follow up
measure: Rates of satisfaction
timeFrame: Post intervention (1 month), 2 months follow up
Secondary outcomes:
measure: Change in Depression symptoms
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
measure: Change in Anxiety (GAD-& score)
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
measure: Change in PTSD symptoms
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
measure: Change in perceived symptoms
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
measure: Change in blood pressure
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
measure: Change in adiposity
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
measure: Heart rate variability (HRV)
timeFrame: Baseline, Post intervention (1 month), 2 months follow up
Other outcomes:
Locations:
Study officials:
affiliation: Rollins School of Public Health
name: Andrea López-Cepero, PhD
role: PRINCIPAL_INVESTIGATOR
References: