Virtual Mindfulness for Pregnancy-Related Stress

Overseen By Olivia J Doyle, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Inability to provide consent

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a feasibility and acceptability study for 4- week virtual mindfulness-based intervention with social support for perinatal individuals at higher risk for substance use. This study builds on the longitudinal collection of questionnaire data from pregnant and postpartum people during the COVID-19 pandemic. Each closed virtual support group will meet weekly for 4 weeks using a video conference platform. Groups will be focused on grounding, thinking patterns, self-compassion and self-care. This approach will foster increase awareness of wellbeing as well as social support between group participants. Primary outcomes include the feasibility and acceptability of this group-based intervention for perinatal individuals.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Virtual Mindfulness-Based Intervention for pregnancy-related stress?

Research shows that mindfulness-based treatments can help reduce stress and anxiety in pregnant women. Studies have found that these interventions can lead to increased mindfulness and decreased pregnancy-related anxiety, although the effects may not last long after the treatment ends. ^{1 2 3 4 5}

Is virtual mindfulness safe for pregnant women?

Virtual mindfulness interventions are generally considered safe for pregnant women, as they are non-pharmacological (not involving medication) and have been shown to help reduce symptoms of stress, anxiety, and depression without reported adverse effects. ^{1 2 6 7 8}

How does the Virtual Mindfulness-Based Intervention treatment differ from other treatments for pregnancy-related stress?

The Virtual Mindfulness-Based Intervention is unique because it is a digital, non-drug approach that focuses on mindfulness practices to help reduce stress, anxiety, and depression during pregnancy. Unlike traditional treatments that may involve medication, this intervention is accessible online, making it a flexible and low-cost option for pregnant women who may be hesitant to use medications. ^{1 4 7 8 9}

Research Team

Kristen Mackiewicz Seghete, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for English-speaking pregnant individuals with a single baby who have had significant substance use or are in treatment for substance abuse. It's not suitable for those unable to consent.

Inclusion Criteria

You have a history of using drugs or alcohol excessively or are currently being treated for addiction.

Currently pregnant

Fluently speak English

Exclusion Criteria

Inability to provide consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-week virtual mindfulness-based intervention with social support

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for psychological distress and pregnancy-specific stress

4 weeks

Treatment Details

Interventions

• Virtual Mindfullness-Based Intervention

Trial Overview The study tests a 4-week virtual mindfulness program with social support, aimed at improving mental health and reducing substance use during pregnancy. Participants will join weekly video group sessions focusing on grounding, thinking patterns, self-compassion, and self-care.

Participant Groups

Group I: Virtual Mindfullness-Based Support Group Experimental Treatment 1 Intervention

The virtual mindfulness-based intervention with social support groups will meet once a week for 4 weeks, each session will be 60 minutes. Each group will have 3-8 participants. The groups will be closed, meaning the same group of participants meet with the same instructor (unless a backup instructor is needed due to unavoidable reasons). Groups will be completed using the video conferencing application.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Findings from Research

This study aims to assess the feasibility of a randomized controlled trial involving 75 pregnant women to compare the effectiveness of two web-based interventions (mindfulness and loving-kindness) against a control (progressive muscle relaxation) over 8 weeks.

If successful, the findings could support the development of accessible and low-cost online programs to improve psychological well-being and reduce distress among pregnant women, which is crucial for both maternal and infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial. Finlay-Jones, AL., Davis, JA., O'Donovan, A., et al.[2020]

A pilot study involving 48 women found that both a mindfulness intervention and a pregnancy support program effectively reduced perceived stress, with the mindfulness group showing greater improvement in present moment awareness.

Participants in the mindfulness program reported enhanced self-acceptance and stress management skills, suggesting that mindfulness may help women become less reliant on external support for their well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial. Beattie, J., Hall, H., Biro, MA., et al.[2018]

Mind-body interventions, including mindfulness, cognitive behavioral therapy, relaxation techniques, and yoga, significantly reduce stress in pregnant women, with a large effect size (SMD=-0.94) based on a systematic review of 28 studies involving 1944 participants.

These interventions not only lower antenatal stress but also help reduce anxiety and depression during pregnancy, suggesting they are safe and effective options for managing mental health in expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. Guo, P., Zhang, X., Liu, N., et al.[2021]

A study is underway involving 240 pregnant women with a history of mental disorders or psychosocial vulnerabilities to evaluate the effectiveness of an adapted Mindfulness-Based Stress Reduction (MBSR) program in improving mental wellbeing and reducing stress during pregnancy.

The primary goal is to assess mental wellbeing nine months after randomization, with secondary outcomes including anxiety, depression, and maternal attachment, highlighting the potential of MBSR as a non-pharmacological intervention for enhancing perinatal mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. Skovbjerg, S., Sumbundu, A., Kolls, M., et al.[2023]

A pilot study involving 59 pregnant patients showed that using a mindfulness app significantly reduced perceived stress levels by an average of 6.3 points between the second and third trimesters, compared to a historical control group.

Despite limited adherence to the app, the findings suggest that prenatal mindfulness practices could be a valuable nonpharmacologic intervention for managing stress during pregnancy, offering a low-cost and accessible option for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness Application for Reducing Prenatal Stress. Porter, AC., Hunter, S., Noonan, K., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial. [2020]

2. Scotland pubmed.ncbi.nlm.nih.gov

Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Randomised controlled pilot trial of mindfulness training for stress reduction during pregnancy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Mindfulness Application for Reducing Prenatal Stress. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Digital Mindfulness Interventions on Depressive, Anxiety, and Stress Symptoms in Pregnant Women: A Systematic Review and Meta-Analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The Effects of MBSR Programme on Prenatal Comfort and Fetal Health Anxiety in Pregnant Women. [2023]