N/A
Completed N=24
Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico
Psychological distress · Cardiometabolic Syndrome
Source: ClinicalTrials.gov NCT06250738 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Rates of Recruitment and Retention — 24; 24; 23 Participants
Summary
The goal of this clinical trial is to evaluate the feasibility and acceptability of a 4-week mindfulness program among young women in Puerto Rico with elevated stress. The main questions it aims to answer are:
* how feasible and acceptable is a s a 4-week mindfulness program among participants with elevated stress
* what are the changes in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers
Participants will be asked to
* attend 4 weekly virtual sessions and daily mindfulness exercises at home
* complete online study questionnaires
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Recruitment and Retention |
24; 24; 23 | — |
| PRIMARY Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home |
0; 4; 8; 8; 3; 1 | — |
| PRIMARY Adherence to the Program: Number of 4-week MBSR Sessions Joined |
0; 0; 2; 2; 20 | — |
| PRIMARY Ratings of Satisfaction (Overall) |
19; 4; 1; 0 | — |
| PRIMARY Ratings of Satisfaction Pre and Post Intervention |
3; 16; 4; 1; 0; 1 | — |
| SECONDARY Change in Depression Symptoms: CSED-10 Scores |
13.4; 8.3; 8.8 | — |
| SECONDARY Change in Anxiety Symptoms: GAD-7 Scores |
9.0; 6.0; 5.5 | — |
| SECONDARY Change in PTSD Symptoms: Civilian Abbreviated Scale |
6.6; 4.8; 4.3 | — |
| SECONDARY Change in Perceived Stress (Perceived Stress Scale) |
8.7; 6.0; 5.7 | — |
| SECONDARY Shift-and-persist (Chen et al) |
24.0; 26.5; 26.6 | — |
| SECONDARY Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15) |
3.1; 3.4; 3.5 | — |
| SECONDARY Change in Psychological Flexibility: Acceptance and Action Questionnaire - II |
24.0; 17.9; 18.1 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals residing in Puerto Rico
- Spanish speaking
- Elevated stress (defined as a score >6 in the Perceived Stress Scale (PSS-4)34)
- Willing to undergo research activities (focus group discussions).
Exclusion Criteria
- 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)
- Prisoners
- Cognitively impaired or Individuals with Impaired Decision-Making Capacity
Data sourced from ClinicalTrials.gov (NCT06250738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.