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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 and 8 weeks for reporting.

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 more
Secondary 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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
979 Previous Clinical Trials
7,385,961 Total Patients Enrolled
1 Trials studying Postpartum Depression
56 Patients Enrolled for Postpartum Depression
National Institute of General Medical Sciences (NIGMS)NIH
272 Previous Clinical Trials
246,523 Total Patients Enrolled
Oregon State UniversityOTHER
50 Previous Clinical Trials
7,946 Total Patients Enrolled

Media Library

MBSC (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04821544 — N/A
Postpartum Depression Research Study Groups: Mindfulness-based intervention (with a focus on self-compassion; MBSC), Control
Postpartum Depression Clinical Trial 2023: MBSC Highlights & Side Effects. Trial Name: NCT04821544 — N/A
MBSC (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04821544 — N/A
~122 spots leftby Jun 2025
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