Mindfulness Training for Postpartum Depression

(MORPHE Trial)

Recruiting at 1 trial location

Overseen By Emily S Miller, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nina Ayala

Disqualifiers: Mind-body practice, Hypertension, Diabetes, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness app designed to help first-time pregnant mothers who feel less optimistic about the future. Researchers aim to determine if the app can boost optimism and improve pregnancy and mental health outcomes. Participants will either use the mindfulness app, Digital Mindfulness Training, or receive standard prenatal care. The trial seeks first-time mothers who are less than 20 weeks pregnant, have a single baby, and own a smartphone. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance prenatal care and mental 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.

What prior data suggests that this mindfulness training is safe for postpartum depression?

A previous study found that using technology to support mindfulness exercises helped prevent depression in new mothers, particularly in countries with fewer resources. This suggests that digital mindfulness training could improve mental health during and after pregnancy. However, specific safety information for using mindfulness training to address postpartum depression is not available.

Research on digital mindfulness apps typically examines their effectiveness in reducing depression symptoms and enhancing well-being. These studies have not reported major safety issues, but they note that some users might stop using the app early due to limited support or guidance.

Overall, digital mindfulness training appears safe, but it's important to consider personal comfort with using an app. If there are any concerns, consulting a healthcare provider can help determine if it's the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital mindfulness training for postpartum depression because it offers a fresh, accessible approach compared to traditional treatments like therapy and medication. This method leverages an app to deliver daily mindfulness exercises, making it convenient for new moms who might struggle to find time for regular therapy sessions. Unlike medications, which can have side effects, mindfulness focuses on mental wellness through stress reduction and emotional regulation, potentially offering a gentler alternative for managing postpartum depression.

What evidence suggests that this digital mindfulness training is effective for postpartum depression?

Research has shown that digital mindfulness training, which participants in this trial may receive, can help reduce postpartum depression. One study found that mindfulness activities specifically benefited women with postpartum depression. Another study suggested that using technology for mindfulness could help prevent depression in new mothers, especially in low-income areas. Although one electronic mindfulness program did not significantly reduce depression or anxiety, it positively affected pregnancy-related outcomes. Overall, digital health tools, like mindfulness apps, seem promising in helping new mothers manage their mental health. Participants in this trial will receive either app-based mindfulness training or usual care to evaluate these effects. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for first-time pregnant mothers with low optimism early in pregnancy (less than 20 weeks), who speak English, can consent, and have a smartphone. They must not have had a prior delivery at or beyond 20 weeks gestation.

Inclusion Criteria

English speaking

Owns a smart phone

Pregnant with singleton fetus

Exclusion Criteria

I regularly practice mindfulness, meditation, or yoga at least once a week.

Plan to deliver at another institution

Pre-gestational hypertensive disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the mindfulness training arm complete 8 weeks of daily mindfulness training exercises using Expectful

8 weeks

4 visits (virtual) for questionnaire completion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum assessments

6-12 weeks postpartum

1 visit (virtual) for postpartum assessment

What Are the Treatments Tested in This Trial?

Interventions

• Digital Mindfulness Training

Trial Overview

The study tests the use of Expectful, a mindfulness app designed for pregnant women, against standard care to see if it improves optimism and reduces negative outcomes like cesarean deliveries and postpartum stress.

How Is the Trial Designed?

Group I: App-based mindfulness training Experimental Treatment 1 Intervention

App-based daily mindfulness training Standard prenatal and pregnancy care

Group II: Usual Care Active Control 1 Intervention

Standard prenatal and pregnancy care

Who Is Running the Clinical Trial?

Nina Ayala

Lead Sponsor

Trials

1

Recruited

100+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

Published Research Related to This Trial

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]

A study involving 168 pregnant women showed that an 8-week smartphone-based mindfulness training significantly improved symptoms of perinatal depression and anxiety compared to a control group, with medium effect sizes observed.

The mindfulness training was particularly beneficial for nulliparous women (first-time mothers), who experienced greater reductions in depression symptoms, indicating that this group may be especially responsive to mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. Sun, Y., Li, Y., Wang, J., et al.[2021]

Mindfulness-Based Interventions (MBIs) delivered during pregnancy significantly reduce the severity of postpartum depression (PPD) symptoms in the first three months after childbirth, based on a systematic review of six randomized controlled trials involving pregnant women.

The effectiveness of MBIs was particularly notable in women who began the interventions with a low risk of developing PPD, suggesting that MBIs could be a beneficial preventive strategy for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions During Pregnancy and Long-Term Effects on Postpartum Depression and Maternal Mental Health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Trapani, S., Caglioni, M., Villa, G., et al.[2023]

This study will evaluate the effectiveness of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program, including compassion training, for reducing perinatal depression in 122 pregnant women and their partners in primary care settings.

The trial aims to provide evidence for a low-cost, non-pharmacological intervention that could serve as a preventive measure against mood disorders during pregnancy and postpartum, with outcomes assessed at multiple time points using standardized measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial. Sacristan-Martin, O., Santed, MA., Garcia-Campayo, J., et al.[2020]

The study involved 16 women with probable perinatal depression who participated in an 8-week mindfulness-based program, revealing that mindfulness training helped them become more aware of their physical and emotional changes during and after pregnancy.

Participants reported improved family relationships and greater confidence in managing childbirth challenges, suggesting that mindfulness interventions can be effective in addressing depressive symptoms in perinatal women and should be included in prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Mindfulness Techniques to the Management of Depressive Tendencies in Women in Taiwan in the Perinatal Period: A Qualitative Study. Pan, WL., Gau, ML., Hsu, TC., et al.[2022]

Mindfulness training significantly reduced symptoms of postpartum depression in new mothers, as evidenced by a decrease in Beck Depression Inventory scores from a mean of 24.75 to 18.5 after 8 sessions of training.

In a study involving 67 mothers, the experimental group that received mindfulness training showed a statistically significant improvement (p<0.001) compared to the control group, which did not receive any training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness training on reducing the symptoms of postpartum depression. Sheydaei, H., Ghasemzadeh, A., Lashkari, A., et al.[2020]

Mindfulness-based interventions (MBIs) significantly reduce depressive symptoms in pregnant women, with a strong effect size in both case-control and self-control studies, indicating their potential effectiveness in preventing postpartum depression.

However, MBIs are not effective for high-risk pregnant women with severe depressive symptoms prior to delivery and do not show significant advantages over other intervention methods, suggesting that they may not be suitable for all pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based interventions during pregnancy on postpartum mental health: A meta-analysis. Min, W., Jiang, C., Li, Z., et al.[2023]

A mobile-delivered mindfulness-based intervention (MBI) significantly reduced perinatal depression in 75 pregnant women, with effects lasting into the postpartum period, as evidenced by a substantial decrease in depression scores.

The MBI also correlated with improved obstetric outcomes, including a reduced risk of emergency cesarean sections and higher Apgar scores for newborns, suggesting that addressing maternal mental health can positively impact both mother and baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antenatal mobile-delivered mindfulness-based intervention to reduce perinatal depression risk and improve obstetric and neonatal outcomes: A randomized controlled trial. Leng, LL., Yin, XC., Chan, CLW., et al.[2023]

In a study of 45 new mothers with postpartum depression (PPD) treated with an SSRI, those who received additional detached mindfulness (DM) or stress management training (SMT) showed significantly greater reductions in depression symptoms compared to those receiving only medication.

The improvements in depression symptoms were not only significant during the 8-week treatment period but also remained stable at the follow-up, indicating that combining psychotherapy with pharmacological treatment can lead to longer-lasting benefits for mothers with PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of adjuvant detached mindfulness and stress management training compared to pharmacologic treatment in primiparae with postpartum depression. Ahmadpanah, M., Nazaribadie, M., Aghaei, E., et al.[2018]

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