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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual mindfulness program designed to reduce stress in pregnant individuals at higher risk for substance use. Participants will join small online support groups once a week for four weeks, focusing on grounding techniques, self-compassion, and self-care. The goal is to assess the practicality and effectiveness of this approach in improving well-being and social support during pregnancy. This trial may suit those who are currently pregnant, expecting a single baby, speak English, and have significant substance use issues or are in treatment for it. As an unphased trial, this study offers a unique opportunity to explore innovative stress-reduction techniques during pregnancy.

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 prior data suggests that this virtual mindfulness-based intervention is safe for perinatal individuals?

Research shows that mindfulness activities are generally safe for pregnant people. Studies have found that these activities can help reduce stress and anxiety during pregnancy. For instance, one study found that using a mindfulness app early in pregnancy was practical and helped lower stress levels. Another study showed that mindfulness techniques might improve mood and reduce anxiety.

These findings suggest that pregnant people tolerate mindfulness practices well, with no major negative effects reported. Therefore, those considering a mindfulness program can rely on current research, which supports its safety and potential mental health benefits during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual mindfulness-based interventions for pregnancy-related stress because they offer a unique blend of mental health support and accessibility. Unlike traditional therapies, which often require in-person visits, this treatment is delivered through video conferencing, making it convenient for expectant mothers to participate from the comfort of their homes. This approach not only reduces the stress of scheduling and travel but also fosters a supportive community by connecting small groups of participants with consistent guidance from the same instructor. These features make it a promising alternative to traditional options like in-person therapy or medication.

What evidence suggests that this virtual mindfulness-based intervention is effective for pregnancy-related stress?

Research has shown that mindfulness-based treatments can reduce stress and anxiety in pregnant women. Studies have found these methods lead to less stress and fewer feelings of anxiety and depression. This trial will evaluate a Virtual Mindfulness-Based Intervention, where participants join a virtual mindfulness-based support group. One study specifically examined online mindfulness programs for pregnant women and found them effective in reducing pregnancy-related stress. Another study noted that mindfulness group therapy lowered stress, anxiety, and depressive symptoms in women expecting twins. Even self-guided online mindfulness programs have demonstrated benefits for managing stress during pregnancy. Thus, there is strong evidence that mindfulness can help manage stress during this time. ^{4 6 7 8 9}

Who Is on the Research Team?

Kristen Mackiewicz Seghete, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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

Have a single gestation pregnancy

Exclusion Criteria

Inability to provide consent

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

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