Mindfulness-Based Stress Reduction for Mothers with Preterm Infants

Recruiting at 1 trial location

Overseen By Yimin Chen, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Idaho

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an 8-week mindfulness program focused on self-compassion (Mindfulness-Based Stress Reduction with Self-Compassion, or MBSC) or a daily vitamin D supplement can reduce stress and boost self-compassion in mothers with preterm infants. Researchers are also examining how these treatments might improve breast milk quality and benefit infants' health. The study includes three groups: one receiving mindfulness training, another taking vitamin D gummies, and a control group with no immediate intervention. Mothers with newborns in the Kootenai Health NICU or the Palouse region are eligible to join. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to enhance maternal and infant well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mindfulness-Based Self-Compassion (MBSC) is generally safe for participants. In earlier studies, mothers who joined mindfulness programs reported feeling calmer and more connected, with no major side effects, suggesting that MBSC is well-tolerated.

Vitamin D, a common supplement, is usually safe at doses like 2000 IU per day. Although very high doses can cause problems, the amount used in this study is safe for most people.

Both treatments have demonstrated safety in previous research, making them promising options for this study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mindfulness-based intervention with a focus on self-compassion (MBSC) because it takes a unique approach to stress reduction for mothers with preterm infants. Unlike traditional therapies that might rely on medication or cognitive behavioral therapy, MBSC emphasizes self-compassion through daily mindfulness practices and guided meditations. This intervention aims to empower mothers by fostering a supportive community with group video sessions led by a certified facilitator. Additionally, the inclusion of Vitamin D gummies as an experimental arm acknowledges the potential role of nutrition in supporting mental health. This holistic approach could offer a novel pathway to improving well-being in a population that often experiences high stress levels.

What evidence suggests that this trial's treatments could be effective for reducing stress in mothers of preterm infants?

Research has shown that mindfulness-based self-compassion (MBSC), one of the treatments studied in this trial, can help reduce stress and anxiety in mothers, particularly those facing challenges like having a premature baby. A review of studies found that mindfulness and relaxation techniques significantly lower stress, anxiety, and depression in mothers with babies in neonatal intensive care units. Mothers participating in mindfulness programs reported feeling calmer and more connected, suggesting mindfulness as an effective way to manage stress. However, one study found that mindfulness exercises alone might not reduce stress for all parents of premature babies. These mixed results highlight the potential benefits of MBSC while acknowledging it might not work for everyone. Another arm of this trial evaluates the effects of Vitamin D supplementation, tested for its potential impact on stress and well-being. ^{2 3 6 7 8}

Who Is on the Research Team?

Yimin Chen, PhD

Principal Investigator

University of Idaho

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Mothers of preterm infants (<36 weeks gestation) at Oregon Health and Sciences University

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into control, mindfulness intervention, or vitamin D supplementation groups for 8 weeks

8 weeks

4 video conference group sessions for mindfulness group

Follow-up

Participants are monitored for changes in stress, self-compassion, and human milk composition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MBSC

Trial Overview 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.

How Is the Trial Designed?

Group I: Vitamin D Experimental Treatment 1 Intervention

Vitamin D gummies of 2,000 IU/day for 8 weeks.

Group II: Mindfulness-based intervention (with a focus on self-compassion; MBSC) Experimental Treatment 1 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 III: Control Active Control 1 Intervention

Control group will receive link to a free 8-week Mindfulness Based Stress Reduction intervention AFTER the 8-weel trial period. This group will also receive placebo gummies that appear the same as the vitamin D gummies.

Who Is Running the Clinical Trial?

University of Idaho

Lead Sponsor

Trials

21

Recruited

2,800+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Oregon State University

Collaborator

Trials

51

Recruited

8,300+

Kootenai Health

Collaborator

Trials

3

Recruited

740+

Published Research Related to This Trial

An 8-week mindfulness-based stress reduction (MBSR) and self-compassion (SC) program for parents of children with autism spectrum disorder (ASD) showed promising results in reducing stress and anxiety, as well as increasing mindful attention awareness among participants.

Although the study involved only 12 parents, with 10 completing the program, the findings suggest a need for larger clinical trials to better understand the efficacy of MBSR and SC in this population and to support their integration into community intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction (MBSR) and Self Compassion (SC) Training for Parents of Children with Autism Spectrum Disorders: A Pilot Trial in Community Services in Spain. Rojas-Torres, LP., Alonso-Esteban, Y., López-Ramón, MF., et al.[2021]

Mindfulness-based stress reduction (MBSR) significantly reduced psychological stress, anxiety, and depression in breast cancer patients compared to standard care, based on a review of 14 studies involving 2,224 participants.

While MBSR improved sleep quality, it did not have a significant impact on fatigue or overall quality of life, indicating that while it is beneficial for certain psychological aspects, its effects on physical well-being may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of mindfulness-based stress reduction vs. standard or usual care in patients with breast cancer: a systematic review and meta-analysis of randomized controlled trials. Wu, H., Li, F., Zhang, F.[2022]

Mothers of preterm infants in the NICU reported high levels of stress and depressive symptoms, which were linked to elevated serum cytokines and abnormal cortisol and α-amylase levels, indicating a physiological response to stress.

The study suggests that the psychological distress experienced by these mothers could lead to poorer physical and mental health outcomes, highlighting the need for effective support strategies for maternal mental health during this challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring biobehavioral outcomes in mothers of preterm infants. Howland, LC., Pickler, RH., McCain, NL., et al.[2021]

Mindfulness-based stress reduction significantly decreased posttraumatic stress disorder (PTSD) symptoms in mothers of premature neonates, with notable improvements measured immediately after the intervention and one month later, based on a study of 60 mothers.

The intervention group showed a more substantial reduction in PTSD symptoms over time compared to the control group, suggesting that mindfulness techniques could be beneficial in care programs for these mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Stress Reduction on Posttraumatic Stress of Mothers With Premature Neonates Admitted to a Neonatal Intensive Care Unit. Izadi, M., Ghaedi-Heidari, F., Sadeghi, T., et al.[2022]

A brief self-compassion intervention significantly improved mental health outcomes, including reduced posttraumatic stress symptoms and depression, for mothers of infants, with 62.8% of participants actively using the online resources provided.

The effectiveness of the intervention was influenced by the mothers' initial fears of compassion, suggesting that addressing these fears may enhance the benefits of self-compassion training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a brief online self-compassion intervention for mothers of infants: Effects on mental health outcomes. Lennard, GR., Mitchell, AE., Whittingham, K.[2021]

Parents of infants in the NICU experience significant stress due to factors like prematurity, high-tech environments, and concerns about their infant's health, which can negatively impact bonding and lead to postpartum depression.

Mindfulness-based strategies have been shown to reduce stress in the general population, and this article explores their potential application for NICU parents, suggesting that effective stress management could improve both parental adaptation and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Strategies: A Cost-Effective Stress Reduction Method for Parents in the NICU. Joseph, R., Wellings, A., Votta, G.[2020]

The Mindfulness-Based Childbirth and Parenting Program (MBCP) significantly reduced perceived stress and depressive symptoms in first-time pregnant women at risk of perinatal depression, compared to a Lamaze childbirth class, with 197 participants involved in the study.

MBCP also increased positive states of mind and self-reported mindfulness, suggesting that enhancing mindfulness may be a key mechanism in reducing stress and depression during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a mindfulness based childbirth and parenting program on pregnant women's perceived stress and risk of perinatal depression-Results from a randomized controlled trial. Lönnberg, G., Jonas, W., Unternaehrer, E., et al.[2021]

In a pilot study involving 30 mothers of premature babies, practicing mindfulness during Kangaroo Care (MKC) significantly reduced anxiety, depression, and stress levels, indicating its potential as a supportive intervention in the NICU.

The majority of mothers found the MKC intervention acceptable and feasible, suggesting that integrating mindfulness practices into Kangaroo Care could be beneficial for parental well-being during stressful NICU experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful Kangaroo Care: mindfulness intervention for mothers during skin-to-skin care: a randomized control pilot study. Landry, MA., Kumaran, K., Tyebkhan, JM., et al.[2022]

Mindfulness-Based Stress Reduction (MBSR) significantly increased Posttraumatic Growth (PTG) in mothers of premature infants, as shown by a study involving 60 mothers over three weeks.

The study found a statistically significant difference in PTG scores between the intervention and control groups, suggesting that MBSR should be included in psychological support programs for these mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness on Posttraumatic Growth of Mothers of Premature Infants Admitted to Neonatal Intensive Care Unit. Ghaedi-Heidari, F., Izadi, M., Seyedbagheri, S., et al.[2023]

A mindfulness-based training session (MBTS) was successfully implemented for parents of neonates in a level 3 NICU, with 51 out of 98 parents consenting to participate and 28 completing the program.

Most parents (79%) found the mindfulness practice helpful, and 71% intended to continue practicing after discharge, indicating potential benefits for coping, although no significant changes were observed in stress levels or mindfulness scores at discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Training among Parents with Preterm Neonates in the Neonatal Intensive Care Unit: A Pilot Study. Marshall, A., Guillén, Ú., Mackley, A., et al.[2020]

Citations

1. withpower.com withpower.com/trial/mindfulness-based-stress-reduction-for-mothers-with-preterm-infants-6b06d

Mindfulness-Based Stress Reduction for Mothers with ... The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9388971/

Mindfulness and Relaxation-Based Interventions to ... The aim of this systematic review was to evaluate whether mindfulness and/or relaxation-based interventions reduce stress, anxiety, and depression in NICU ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12181856/

Mindfulness-Based Stress Reduction adapted to pregnant ... The results from this trial suggest that prenatal MBSR is a feasible intervention for a clinical setting, supporting the conduct of an RCT.

4. link.springer.com link.springer.com/article/10.1007/s12671-022-02060-w

Exploring the Influence of a Mindfulness Intervention on ... Mothers reported that participation in the mindfulness intervention helped them to calm the chaos through recentering and fostering connections.

5. researchgate.net researchgate.net/publication/330769804_Mindfulness_Training_among_Parents_with_Preterm_Neonates_in_the_Neonatal_Intensive_Care_Unit_A_Pilot_Study

Mindfulness Training among Parents with Preterm ... [11] in America revealed that the use of mindfulness exercises is not effective in reducing the stress of parents of premature babies, which is ...

6. mdpi.com mdpi.com/2227-9067/8/5/316

Mindfulness-Based Stress Reduction (MBSR) and Self ... This study aims to develop a clinical trial to test the efficacy of a mindfulness-based stress reduction (MBSR) and self-compassion (SC) program

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9838379/

Exploring the Influence of a Mindfulness Intervention on ... Mothers reported that participation in the mindfulness intervention helped them to calm the chaos through recentering and fostering connections.

8. link.springer.com link.springer.com/article/10.1007/s10567-025-00549-z

A Compassion-Focused Approach to Support Parents After ... This paper explores the complex psychological experiences and intrapersonal processes of parents after preterm birth, highlighting their ...