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

Emory University

Status: Not yet enrolling

Conditions: Anxiety; Stress

Treatments: Behavioral: Usual care; Behavioral: Mindfulness-based stress reduction :MBSR

Study type: Interventional

Funder types: Other

Identifiers

NCT06909526

STUDY00007906

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

MBSR: Mindfulness-based stress reduction

Experimental group

Description:

* 4-week intervention (1 weekly virtual session; daily mindfulness exercises at home) * 3 study assessments (baseline, post-intervention, 1 month post-intervention)

Treatment:

Behavioral: Mindfulness-based stress reduction :MBSR

Usual care group

Placebo Comparator group

Description:

Placebo Comparator: Usual care group * No intervention, but participants will have access to audio files and a mindfulness information sheet after study completion * 3 study assessments (baseline, 1 mo, 2mo)

Treatment:

Behavioral: Usual care