Psychological Distress Clinical Trial
Official title:
Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico: A Pilot of a Mindfulness-based Trial
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 29 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rollins School of Public Helath | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of recruitment and retention | Number of participants at the beginning of the study versus the number of participants at the end of the study. | Baseline, week 4 | |
Primary | Adherence to the program | Measured by the number of phone sessions attended and the frequency of self-reported completed home practice, both assessed at post-intervention assessments | Baseline, week 4 | |
Primary | Ratings of satisfaction | Ratings of satisfaction, also assessed by survey 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?" | Baseline, week 4 | |
Secondary | Change in cardiometabolic markers: Weight | -Baseline and post-intervention secondary outcome data on cardiometabolic markers (adiposity and blood pressure) will be assessed during clinic visits or by self-report when visit to the clinic is not possible | Baseline, week 4 | |
Secondary | Change in cardiometabolic markers: Waist Circumference | -Baseline and post-intervention secondary outcome data on cardiometabolic markers (adiposity and blood pressure) will be assessed during clinic visits or by self-report when visit to the clinic is not possible | Baseline, week 4 | |
Secondary | Change in cardiometabolic markers: Blood Pressure | -Baseline and post-intervention secondary outcome data on cardiometabolic markers (adiposity and blood pressure) will be assessed during clinic visits or by self-report when visit to the clinic is not possible | Baseline, week 4 |
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