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NCT Number: NCT06909526

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

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

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Key information

Conditions

Stress Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-based stress reduction :MBSR

Behavioral

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.

Other names: MBSR

Usual Care

Behavioral

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 outcomes

  1. Rates of recruitment

    Time frame: Baseline

    Number of participants approached for the study versus number of participants that are enrolled.

  2. Rates of retention

    Time frame: Baseline, 2 months follow up

    Number of participants at the beginning of the study versus the number of participants at the end of the study.

  3. Rates of adherence

    Time frame: Post intervention (1-month), 2-month follow up

    Adherence will be measured by the number of phone sessions attended and the frequency of self-reported completed home practice, both assessed at post-intervention assessments.

  4. Rates of satisfaction

    Time frame: Post intervention (1 month), 2 months follow up

    Ratings of satisfaction, also assessed by client satisfaction questionnaire (CSQ-8) in post-intervention assessments, will be measured with several questions, including one that reads "Overall, how satisfied were you with the stress reduction program", "How satisfied are you now (after the stress reduction program) with your ability to manage the stress in your life?", and "How much did the program helped you manage your stress?

Secondary outcomes

  1. Change in Depression symptoms

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    Center for Epidemiological Studies Depression (CESD) 10-item scale, which asks about the frequency of depressed mood, guilt, worthlessness, helplessness, hopelessness, loss of appetite, and sleep disturbance. Score ranges from 0 to 30, with higher scores meaning more depressive symptoms.

  2. Change in Anxiety (GAD-& score)

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    GAD-7 scale, which asks about the frequency of feeling nervous, unable to stop worrying, trouble relaxing, and being easily irritable.

    It includes 7 questions, each scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21. A score of 10 or more suggests clinically significant anxiety and may indicate the need for further evaluation.

  3. Change in PTSD symptoms

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    Civilian Abbreviated Scale from the PTSD Checklist (PCL), which assesses repeated disturbing memories of a stressful past event.

    It typically includes 4 to 6 items, focusing on key symptom clusters from the DSM, such as: Intrusive thoughts (e.g., repeated, disturbing memories of a stressful event) Avoidance of reminders, Negative mood or thoughts, Hyperarousal (e.g., being easily startled)

    Each item is rated on a 5-point scale from "Not at all" to "Extremely". Higher scores indicate more severe symptoms and may suggest the need for further evaluation.

  4. Change in perceived symptoms

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    Perceived Stress Scale (PSS-4) measures the degree to which someone perceives their life situations as overwhelming, uncontrollable, and unpredictable.

    4 items rated on a 5-point Likert scale (0 = Never to 4 = Very often). Higher scores mean greater perceived stress

  5. Change in blood pressure

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    Systolic and diastolic blood pressure will be measured three times, in the sitting position (after a 5-min rest), using an electronic sphygmomanometer (OMRON). Measures will be averaged

  6. Change in adiposity

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    BMI will be calculated from measured weight (light clothes) and height (no shoes).

    Waist circumference will be measured twice (cm) with a Gulick II Plus tape; measures will be averaged

  7. Heart rate variability (HRV)

    Time frame: Baseline, Post intervention (1 month), 2 months follow up

    Fitbit Luxe is a device that measures HRV using the root mean square of successive differences equation72 and has been utilized to assess HRV in research studies. Participants will be instructed to wear the device daily throughout the study period. Data will be abstracted through the device's porta

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea López-Cepero, PhD

CONTACT

[email protected]

404-727-3956

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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