StressNCT06909526
Implementation of a Short Mindfulness-based Program for Young Women in Puerto Rico
A study testing Mindfulness-based stress reduction :MBSR in people with Stress and Anxiety, run by Emory University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- What is being tested?
- Mindfulness-based stress reduction :MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of a Short Mindfulness-based Program for Young Women in Puerto
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
Read the 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.
- Being tested
- Mindfulness-based stress reduction :MBSR, Usual care
- Keywords
- Stress in women, Anxiety in women, Mindfullness, Mindfulness-based stress reduction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction :MBSRBehavioural
Also called 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.
Usual careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| MBSR: Mindfulness-based stress reduction | Experimental | * 4-week intervention (1 weekly virtual session; daily mindfulness exercises at home)
* 3 study assessments (baseline, post-intervention, 1 month post-intervention) Receives: Behavioral: Mindfulness-based stress reduction :MBSR |
| Usual care group | Placebo comparator | 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) Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of recruitment
Number of participants approached for the study versus number of participants that are enrolled.
Measured: Baseline
Rates of retention
Number of participants at the beginning of the study versus the number of participants at the end of the study.
Measured: Baseline, 2 months follow up
Rates of adherence
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.
Measured: Post intervention (1-month), 2-month follow up
Rates of satisfaction
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?
Measured: Post intervention (1 month), 2 months follow up
Secondary outcomes (7)
Change in Depression symptoms
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.
Measured: Baseline, Post intervention (1 month), 2 months follow up
Change in Anxiety (GAD-& score)
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.
Measured: Baseline, Post intervention (1 month), 2 months follow up
Change in PTSD symptoms
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.
Measured: Baseline, Post intervention (1 month), 2 months follow up
Change in perceived symptoms
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
Measured: Baseline, Post intervention (1 month), 2 months follow up
Change in blood pressure
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
Measured: Baseline, Post intervention (1 month), 2 months follow up
Change in adiposity
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
Measured: Baseline, Post intervention (1 month), 2 months follow up
Heart rate variability (HRV)
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
Measured: Baseline, Post intervention (1 month), 2 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Andrea Lopez-Cepero, Emory University
- Investigators
- Andrea López-Cepero, PhD, Principal investigator, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909526
- Sponsor's protocol ID
- STUDY00007906
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on the following variables may be shared: psychological distress (depression symptoms, anxiety symptoms, PTSD symptoms), resilience (shift and persist, mindfulness), health behaviors (smoking, eating habits), weight, blood pressure, height, sociodemographic (socioeconomic variables, age), number of sessions attended and practice exercise completed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Short Mindfulness-based Program for Young Women in Puerto
- ClinicalTrials.gov ID
- NCT06909526
- Acronym / sponsor ID
- STUDY00007906
- Keywords
- Stress in women, Anxiety in women, Mindfullness, Mindfulness-based stress reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR: Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reduction :MBSR* 4-week intervention (1 weekly virtual session; daily mindfulness exercises at home) * 3 study assessments (baseline, post-intervention, 1 month post-intervention) |
| Usual care group | Placebo comparator | Behavioral: Usual carePlacebo 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) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction :MBSRAlso: MBSRThe 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. | Behavioural | MBSR: Mindfulness-based stress reduction |
| Usual careSubjects 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 | Behavioural | Usual care group |
Primary outcome
Rates of recruitment
Time frame: Baseline
Number of participants approached for the study versus number of participants that are enrolled.
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.
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.
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?
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. Data on the following variables may be shared: psychological distress (depression symptoms, anxiety symptoms, PTSD symptoms), resilience (shift and persist, mindfulness), health behaviors (smoking, eating habits), weight, blood pressure, height, sociodemographic (socioeconomic variables, age), number of sessions attended and practice exercise completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea López-Cepero, PhD principal investigator
Rollins School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction :MBSR in people with Stress and Anxiety, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea López-Cepero, PhD (404-727-3956, andrea.a.lopez-cepero@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of recruitment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.