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Behavioral Intervention
Mindfulness-Based Stress Reduction for Mothers with Preterm Infants
N/A
Recruiting
Led By Yimin Chen, PhD
Research Sponsored by University of Idaho
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mothers of preterm infants (<36 weeks gestation) at Oregon Health and Sciences University
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 and 8 weeks
Awards & highlights
Study Summary
This trial will study if a 8-week mindfulness intervention will help reduce stress for mothers of preterm infants and improve the health of their infants.
Who is the study for?
This trial is for mothers of preterm infants born before 36 weeks gestation at Oregon Health and Sciences University. It's designed to help those experiencing stress postpartum, aiming to improve both maternal mental health and infant outcomes.Check my eligibility
What is being tested?
The study tests an 8-week mindfulness-based intervention focused on self-compassion (MBSC). The goal is to see if this approach can reduce maternal stress, enhance the quality of human milk produced, and positively affect the health of preterm infants.See study design
What are the potential side effects?
Mindfulness-based interventions are generally considered safe with minimal side effects. Participants may experience emotional discomfort when addressing stressful experiences but benefits often include improved mental well-being.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 and 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maternal Self-compassion - Biomarker Change
Maternal Self-compassion - Psychometric Measure Change
Maternal Stress - Biomarker Change
+1 moreSecondary outcome measures
Human Milk Proteins & Peptides Change
Infant Metabolomic & Transcriptomic Changes
Maternal Metabolomic & Transcriptomic Changes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-based intervention (with a focus on self-compassion; MBSC)Experimental Treatment1 Intervention
8-week MBSC intervention with a focus on increasing self-compassion. The MBSC program includes previously developed daily mindfulness practices, guided meditations, routine mindfulness prompts, and four video conference group sessions with a certified mindfulness facilitator.
Group II: ControlActive Control1 Intervention
Control group will receive link to a free 8-week Mindfulness Based Stress Reduction intervention AFTER the 8-weel trial period.
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Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,845,529 Total Patients Enrolled
1 Trials studying Postpartum Depression
56 Patients Enrolled for Postpartum Depression
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,260 Total Patients Enrolled
Oregon State UniversityOTHER
49 Previous Clinical Trials
7,881 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-based intervention (with a focus on self-compassion; MBSC)
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to enroll in this scientific research project?
"Applicants to this trial must meet two conditions: they have a medical history of preterm labor and be between 18-50 years old. The study aims to recruit 500 participants in total."
Answered by AI
Are participants of a geriatric age welcome in this research endeavor?
"In order to be included in this trial, patients must be between 18 and 50 years of age."
Answered by AI
Are there opportunities to join this research initiative at present?
"Affirmative, the information accessible on clinicaltrials.gov verifies that this research is seeking participants. This study was initially listed on May 1st 2021 and has undergone its latest revision as of August 11th 2022; it requires 500 individuals from 2 sites to be enrolled in total."
Answered by AI
How many participants is this project recruiting?
"Affirmative. According to the details on clinicaltrials.gov, recruitment for this trial is currently in progress; it was initially advertised on May 1st 2021 and has since been updated as recently as August 11th 2022. 500 participants will be enrolled across two sites of medical care centres."
Answered by AI
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