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

NCT06909526 | Not Yet Recruiting

• 1 other identifier: STUDY00007906
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Stress; Anxiety

Keywords

Stress in women; Anxiety in women; Mindfullness; Mindfulness-based stress reduction

Outcome Measures

Primary Outcomes (4)

• Rates of recruitment

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

  Baseline

• Rates of retention

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

  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.

  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?

  Post intervention (1 month), 2 months follow up

Secondary Outcomes (7)

• Change in Depression symptoms

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

• Change in Anxiety (GAD-& score)

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

• Change in PTSD symptoms

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

• Change in perceived symptoms

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

• Change in blood pressure

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

Study Arms (2)

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)

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)

Behavioral: Usual care

Interventions

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.

Also known as: MBSR

MBSR: Mindfulness-based stress reduction

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

Usual care group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Not identifying as a man, trans man, or trans woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• American Heart Association: collaborator

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrea López-Cepero, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea López-Cepero, PhD

CONTACT

404-727-3956; andrea.a.lopez-cepero@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting January 2027