Mindfulness Training for Depression in Pregnancy

Overseen By Patricia Kinser, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Non-pregnant, Not minority, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called "Mindful Moms" can improve mood and health in pregnant women with depressive symptoms. It compares the effects of this mindfulness training to standard group-based prenatal education. Pregnant women between 12-26 weeks along, who identify as minorities or have lower income or education levels, and have depressive symptoms might be a good match. Participants should be comfortable with English and not have been advised against physical activity by a healthcare provider. The trial is not suitable for those already practicing yoga regularly during their current pregnancy.

As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance prenatal care for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research has shown that the "Mindful Moms" program is generally safe for pregnant women. Studies have found it can reduce feelings of depression, stress, and anxiety without causing harm. Women in similar mindfulness programs reported feeling better and more connected with their babies, experiencing no major negative effects. Overall, mindfulness-based approaches appear well-tolerated, making them a safe choice for pregnant women dealing with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Mindful Moms" program because it offers a fresh approach to managing depression during pregnancy, focusing on mindfulness rather than medication. Unlike traditional treatments like antidepressants, which can have side effects and concerns about use during pregnancy, this approach involves weekly sessions designed to enhance mental well-being through mindfulness techniques. This method is non-invasive and empowers expectant mothers with practical skills to manage stress and improve their mental health, potentially offering a safer and more holistic alternative to medication.

What evidence suggests that the "Mindful Moms" program might be an effective treatment for depression in pregnancy?

Research has shown that mindfulness-based programs, such as "Mindful Moms," which participants in this trial may receive, can help reduce depression symptoms in pregnant women. Studies have found that mindfulness activities can decrease anxiety and boost mood during pregnancy. Women who have used mindfulness-based therapy reported feeling less stressed. A small study also suggested that mindfulness yoga can ease depression in expecting mothers. Overall, these findings provide promising evidence that "Mindful Moms" could improve mental health for pregnant women. Meanwhile, another group in this trial will receive "Prenatal Education," serving as an active comparator. ^{1 2 3 4 6}

Who Is on the Research Team?

Patricia Kinser, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for pregnant women between 12-26 weeks gestation, over 18 years old, with depressive symptoms but not in regular yoga practice. It's aimed at those who haven't been advised against physical activity and can understand English. Priority is given to minorities or those with lower income/education.

Inclusion Criteria

You can understand, read and write English.

I am pregnant and between 12 to 26 weeks along.

Your doctor has not advised you to avoid physical activity.

Exclusion Criteria

Does not meet the inclusion criteria above.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either 12 weeks of group-based prenatal yoga or prenatal education sessions

12 weeks

12 weekly sessions (in-person)

Follow-up

Participants are monitored for mood and health changes postpartum

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindful Moms
• Prenatal Education

Trial Overview The 'Mindful Moms' program aims to improve mood and health in pregnant women with depression. This study compares the effects of this mindfulness-based intervention against group prenatal education workshops.

How Is the Trial Designed?

Group I: Mindful Moms Experimental Treatment 1 Intervention

Weekly "Mindful Moms" sessions

Group II: Prenatal Education Active Control 1 Intervention

Weekly prenatal education sessions

Mindful Moms is already approved in United States for the following indications:

Approved in United States as Mindful Moms for:

• Depression in pregnant women
• Anxiety in pregnant women
• Postpartum depression

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

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]

The 'Mindful Moms' intervention, a 12-week program using prenatal yoga and goal-setting, was found to be feasible and acceptable for pregnant women experiencing depressive symptoms, with positive feedback from participants.

Participants in the 'Mindful Moms' program showed significant reductions in depressive symptoms, anxiety, and perceived stress, suggesting its potential effectiveness in improving mental health during pregnancy, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Kinser, PA., Thacker, LR., Rider, A., et al.[2023]

Mindfulness-based interventions (MBIs) were found to significantly reduce perinatal anxiety in pregnant women, with moderate to large effect sizes reported across 18 studies involving various study designs.

The impact of MBIs on perinatal depression was less clear, showing only moderate reductions in symptoms without significant differences compared to control groups, indicating a need for further research to clarify their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mindfulness-Based Interventions on Maternal Perinatal Mental Health Outcomes: a Systematic Review. Shi, Z., MacBeth, A.[2022]

A 10-week mindfulness yoga (M-Yoga) program for 18 psychiatrically high-risk pregnant women significantly reduced depression symptoms and increased mindfulness and maternal-fetal attachment, indicating its potential as a non-pharmacological treatment option.

This pilot study suggests that M-Yoga is not only feasible and well-accepted but may also serve as an effective alternative or complement to traditional medication for managing prenatal mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness yoga during pregnancy for psychiatrically at-risk women: preliminary results from a pilot feasibility study. Muzik, M., Hamilton, SE., Lisa Rosenblum, K., et al.[2021]

The study is a randomized control trial involving 74 women with a history of major depression, comparing the effectiveness of mindfulness-based cognitive therapy for perinatal depression (MBCT-PD) against standard prenatal care.

The trial aims to explore how MBCT-PD influences emotion regulation and cognitive control, using behavioral assessments and neuroimaging to identify mechanisms that could help prevent postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. Mackiewicz Seghete, KL., Graham, AM., Lapidus, JA., et al.[2023]

An 8-week mindfulness-based cognitive therapy (MBCT) intervention significantly reduced depressive and anxiety symptoms in 38 pregnant women with comorbid conditions, showing its potential as a non-pharmacological treatment option.

The benefits of MBCT were maintained one month after the intervention, indicating its effectiveness in enhancing emotional regulation and overall psychological well-being during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Zemestani, M., Fazeli Nikoo, Z.[2020]

Mindfulness-based cognitive therapy adapted for perinatal depression (MBCT-PD) was found to be acceptable and well-received by pregnant women with histories of depression, showing higher satisfaction and completion rates compared to treatment as usual (TAU).

Participants in the MBCT-PD group experienced significantly lower rates of depressive relapse and reduced depressive symptoms over the 6 months postpartum, indicating its efficacy in preventing depression during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. Dimidjian, S., Goodman, SH., Felder, JN., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05137925

Mechanisms of Mindfulness-based Cognitive Therapy ... Mindfulness Based Cognitive Therapy (MBCT) is an effective approach to mitigate pregnancy-related worsening of psychological distress. However, prior research ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8366589/

Feasibility, Acceptability, and Preliminary Effects of “Mindful ... The 12-week “Mindful Moms” intervention was designed to empower pregnant women with depressive symptomatology to create personal goals and engage in mindful ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1601-0

Mindfulness-based cognitive therapy for psychological ... The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5506176/

The Effectiveness of Mindfulness-Based Interventions on ... Our review offers preliminary evidence for the effectiveness of MBIs in reducing perinatal anxiety, with more equivocal findings with regard to perinatal ...

5. womensmentalhealth.org womensmentalhealth.org/posts/mindfulness-yoga-for-the-treatment-of-depression-during-pregnancy-a-pilot-study/

Mindfulness Yoga for the Treatment of Depression During ... A pilot study from theUniversityofMichigansuggests that mindfulness yoga may also be helpful for relieving depressive symptoms in this setting.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4107206/

CALM Pregnancy: Results of a Pilot Study of Mindfulness ... Three small studies have demonstrated that MBIs are effective in reducing stress, anxiety, depressive symptoms, and emotional distress during pregnancy in ...