Mindfulness Training for Depression in Pregnancy

Overseen by Patricia Kinser, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Commonwealth University

Disqualifiers: Non-pregnant, Not minority, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether a program called "Mindful Moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.

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.

What data supports the effectiveness of the treatment Mindful Moms, Mindfulness-Based Cognitive Therapy (MBCT), Yoga-based mindfulness intervention, Prenatal Education, Antenatal Education, Childbirth Education, Pregnancy Classes for depression in pregnancy?

Research shows that mindfulness-based interventions, like Mindful Moms and mindfulness yoga, can significantly reduce depression symptoms in pregnant women. Mindfulness-Based Cognitive Therapy (MBCT) has strong evidence for preventing depression relapse and shows promise when adapted for perinatal depression. ^{1 2 3 4 5}

Is mindfulness training safe for pregnant women with depression?

Mindfulness-based interventions, including Mindful Moms and Mindfulness-Based Cognitive Therapy, have been studied in pregnant women and are generally considered safe. These non-drug treatments focus on self-management and have shown potential benefits for mental health without significant safety concerns. ^{1 4 5 6 7}

How is the Mindful Moms treatment different from other treatments for depression in pregnancy?

Mindful Moms is unique because it combines mindfulness-based cognitive therapy with yoga, focusing on empowering pregnant women to set personal goals and engage in mindful physical activity, offering a non-drug alternative to traditional pharmacological treatments. ^{1 2 3 4 5}

Research Team

Patricia Kinser, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Mindful Moms (Behavioral Intervention)
• Prenatal Education (Behavioral Intervention)

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.

Participant Groups

Group I: Mindful Moms Experimental Treatment 1 Intervention

Weekly "Mindful Moms" sessions

Group II: Prenatal Education Active Control 1 Intervention

Weekly prenatal education sessions

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness yoga during pregnancy for psychiatrically at-risk women: preliminary results from a pilot feasibility study. [2021]

3. United States 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. [2022]

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

Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. [2023]

5. Netherlands 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. [2021]

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

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

7. Austria pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. [2020]